A PHASE 1b/2 STUDY OF PF-07901801, A CD47 BLOCKING AGENT, WITH TAFASITAMAB AND LENALIDOMIDE FOR PARTICIPANTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B CELL LYMPHOMA NOT ELIGIBLE FOR STEM CELL TRANSPLANTATION
Phase: PHASE1
Conditions: Diffuse Large B-Cell Lymphoma
Sponsor: Pfizer

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1
A P H A S E 1 b / 2 S T U D Y O F P F-0 7 9 0 1 8 0 1, A C D 4 7 B L O C KI N G A G E N T, WI T H 
T A F A SI T A M A B A N D L E N A LI D O M I D E F O R P A R TI CI P A N T S WI T H 
R E L A P S E D/ R E F R A C T O R Y DI F F U S E L A R G E B C E L L L Y M P H O M A N O T E LI GI B L E 
F O R S T E M C E L L T R A N S P L A N T A T I O N
St u d y I nter ve nti o n N u m ber:
P F -0 7 9 0 1 8 0 1
St u d y I nter ve nti o n N a me:
N A
U S I N D N u m ber:
I ND 1 3 5 4 2 1
E U C T N u m ber:
N A
Cli nic al Tri als. g o v I D:
N C T 0 5 6 2 6 3 2 2
Pe di atric I n vesti g ati o n al Pl a n N u m ber
N A
Pr ot oc ol N u m ber:
C 4 9 7 1 0 0 3
P h ase:
1 b/ 2
S p o ns or Le g al A d dress:
Pfizer I nc.
6 6 H u ds o n B o ule var d East
Ne w Y or k, N Y 1 0 0 0 1
U nite d States
Brief Title: P hase 1 b/ 2 St u d y  of P F-0 7 9 0 1 8 0 1, Tafasita ma b, a n d Le nali d o mi de i n 
Tra ns pla nt I neli gi ble Rela pse d/ Refract or y  Diff use Lar ge B Cell L ym p h o ma P artici pa nts
T his d oc u me nt a n d acc o m pa n y i n g materials c o ntai n c o nfi de ntial i nf or mati o n bel o n gi n g t o 
Pfizer. E xce pt a s ot her wise a gree d t o i n writi n g, b y acce pti n g or re vie wi n g t hese 
d oc u me nts, y o u a gree t o h ol d t his i nf or mati o n i n c o nfi de nce a n d n ot c o p y o r discl ose it t o 
ot hers (e xce pt w here re q uire d b y  a p plica ble la w) or use it f or u na ut h orize d p ur p oses. I n 
t he e ve nt of a n y act ual or s us pecte d breac h of t his o bli gati o n, Pfizer m ust be pr o m ptl y  
n otifie d.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2
D oc u me nt Hist or y
D oc u me nt
Versi o n D ate
A me n d me nt 2
0 9 Dec 2 0 2 4
A me n d me nt 1
1 4 Marc h 2 0 2 3
Ori gi nal pr ot oc ol
1 8 A u g 2 0 2 2
T his a me n d me nt i nc or p orates all re visi o ns t o date, i ncl u di n g a me n d me nts ma de at t he 
re q uest of c o u ntr y healt h a ut h orities a n d I R Bs/ E Cs a n d a n y pr ot oc ol a d mi nistrati ve c ha n ge 
letter(s).
Pr ot oc ol a n d A me n d me nt S u m m ar y of C h a n ges T a ble
A m e n d me nt 2 (0 9 Dec 2 0 2 4 )
O ver all R ati o n ale f or t he A me n d me nt:
T he p ur p ose of A me n d me nt 2 is t o m o ve t he sec o n dar y  o bjecti ves a n d e n d p oi nts f or P K of 
tafasita ma b a n d le nali d o mi de, as well as i m m u n o ge nicit y of tafasita ma b, t o e x pl orat or y 
o bjecti ves a n d e n d p oi nts . A me n d me nt is als o t o c o nfir m st u d y ter mi nati o n d ue t o b usi ness
decisi o n ma de b y Pfizer . As a res ult of t his decisi o n, P hase 1 b will be disc o nti n ue d after t he 
last partici pa nt last visit a n d P hase 2 of t he st u dy will n ot be i nitiate d .
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
S u bst a nti al M o dific ati o n(s) 
M o ve d t he sec o n dar y  o bjecti ves a n d 
e n d p oi nts f or P K of tafasita ma b a n d 
le nali d o mi de, as well as 
i m m u n o ge nicity of tafasita ma b t o 
e x pl orat or y o bjecti ves a n d e n d p oi nts.
T he P K of tafasita ma b 
a n d le nali d o mi de, as 
well as 
i m m u n o ge nicity of 
tafasita ma b will n ot be 
a nal yz e d d ue t o t he 
li mite d n u m ber of 
sa m ples c ollecte d i n 
P hase 1 b a n d t he 
decisi o n t o disc o nti n ue 
de vel o p me nt of t his 
dr u g c o m bi nati o n
acr oss t he pr o gra m .
Secti o n 1. 1 S y n o psis 
Secti o n 3 O bjecti ves, 
E n d p oi nts, a n d 
Esti ma n ds
Secti o n 9. 3. 3. 3 
P har mac o ki netic 
A nal y ses f or 
P F - 0 7 9 0 1 8 0 1
Secti o n 9. 3. 3. 4 
I m m u n o ge nicity 
A nal y ses f or 
P F - 0 7 9 0 1 8 0 1
Secti o n 9. 3. 4
Tertiar y / E x pl orat or y 
E n d p oi nt(s) A nal ys is
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
A d de d state me nts a b o ut t he st u d y  
ter mi nati o n decisi o n
St u d y  t o be ter mi nate d 
d ue t o strate gic 
b usi ness decisi o n.
Secti o n 1. 1 S y n o psis
Secti o n 1. 2 Sc he ma
Secti o n 2. 1 St u d y  
Rati o nale
Secti o n 2. 3. 1 Ris k 
Assess me nt
Secti o n 3 O bjecti ves, 
E n d p oi nts a n d 
Esti ma n ds
Secti o n 4. 1 O verall 
Desi g n
Secti o n 4. 3. 1. D osi n g 
Re gi me ns of 
P F - 0 7 9 0 1 8 0 1 
Secti o n 6. 3 Assi g n me nt
t o St u d y  Inter ve nti o n
Secti o n 9 Statistical 
C o nsi derati o ns
Secti o n 9. 5 Sa m ple Size 
Deter mi nati o n
Secti o n 1 0. 1 0. 2 
C o u ntr y -s pecific 
Re q uire me nts (Ja pa n)
N o n -S u bst a nti al M o dific ati o n(s)
U p date d t he E U C T n u m ber t o N A ; 
A d de d Cli nical Trials. g o v I D
T he st u d y  was n ot 
s u b mitte d t o t he E U 
a n d n o E U partici pa nts 
were e nr olle d.
Title Pa ge , Secti o n 1. 1 
S y n o psis
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
U p date d t he te xt t o ali g n wit h t he 
latest pr ot oc ol te m plate secti o ns
As re q uire d b y Pfizer 
S O P t o ali g n wit h t he 
res pecti ve pr ot oc ol 
te m plate secti o ns 
Secti o n 1 0. 1. 1 
Re g ulat or y  a n d Et hical 
C o nsi derati o ns
Secti o n 1 0. 1. 4 Data 
Pr otecti o n
Secti o n 1 0. 1. 6 
Disse mi nati o n of 
Cli nical St u d y Data
Secti o n 1 0. 1. 7 Data 
Q ualit y  Ass ura nce
Secti o n 1 0. 1. 1 0. St u d y  
a n d Site Start a n d 
Cl os ure
Secti o n 1 0. 1. 1 1 
P u blicati o n P olic y
Secti o n 1 0. 1. 1 2 
S p o ns or’s Me dicall y 
Q ualifie d I n di vi d ual
A d diti o n of A p pe n di x 1 5.
Rel ocate d t he 
s u m mar y of c ha n ges 
f or pri or a me n d me nts 
t o ali g n wit h t he 
c urre nt pr ot oc ol 
te m plate pr ocesses.
A p pe n di x 1 5: Pr ot oc ol 
A me n d me nt Hist or y
Clarificati o n t hat bl o o d sa m ple f or 
C D 4 7 rece pt or occ u pa nc y will n ot be 
c ollecte d fr o m partici pa nts i n Ja pa n.
( P A C L 3 0 J u n 2 0 2 3)
T his c ha n ge is d ue t o 
l o gistical c halle n ges 
a n d li mitati o ns.
Secti o n 1. 3 Sc he d ule of 
Acti vities:
Bl o o d sa m ple f or C D 4 7 
rece pt or occ u pa nc y
Clarifie d t hat bl o o d sa m ple f or C D 4 7 
rece pt or occ u pa nc y will o nl y be 
c ollecte d fr o m partici pa nts i n t he 
U nite d States a n d its territ ories. 
( P A C L 1 7 N o v 2 0 2 3 )
T his c ha n ge is d ue t o 
l o gistical c halle n ges/ 
li mitati o ns.
Secti o n 1. 3 Sc he d ule of 
Acti vities:
Bl o o d sa m ple f or C D 4 7 
rece pt or occ u pa nc y
T he f oll o wi n g se nte nce was re m o ve d:
“A p pr o xi matel y  6 0 mi n utes m ust 
ela pse after t he c o m pleti o n of 
P F - 0 7 9 0 1 8 0 1 pri or t o t he start of 
i nf usio n of tafasita ma b. ” ( P A C L 
1 7 N o v 2 0 2 3)
T o pr o vi de clarit y a n d 
c o nsiste nc y wit h t he 
la n g ua ge t hat was 
pre vi o usl y  u p date d i n 
S ecti o n 6. 1. 1. 1.
Secti o n 6. 1. 1 
A d mi nistrati o n
A d de d te xt f or Pfizer re vie w of 
eli gi bilit y data. ( P A C L 1 7 N o v 2 0 2 3)
T o re d uce ris k f or 
e nr ollme nt of n o n -
Secti o n 5. St u d y  
P o p ulati o n
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
eli gi ble partici pa nts, 
d ue t o t he c o m ple xities 
of t he 
i ncl usi o n/e xcl usi o n 
criteria.
A d de d te xt Fl u oresce nce i n sit u 
h y bri dizati o n ( FI S H) testi n g is 
re q uire d pri or t o e nr oll me nt if 
hist orical res ults are n ot a vaila ble . 
( P A C L 1 7 N o v 2 0 2 3) 
Clarifie d t hat if t hese 
tests were n ot d o ne as 
part of pri mar y  
dia g n osis or res ults are 
n ot a vaila ble i n 
me dical hist or y , 
detecti o n of M Y C a n d 
B C L 2 a n d/ or B C L 6 
rearra n ge me nts s h o ul d 
be c o n d ucte d pri or t o 
e nr oll me nt t o verif y  
e xcl usi o n criteria 3 
hi g h -gra de l y m p h o ma.
Secti o n 5. 2 E xcl usi o n 
Criteria, f or E xcl usi o n 
Criteria 3
A d de d te xt f or ti mi n g of bl o o d 
c ollecti o n f or la b orat or y tests, vital 
si g ns a n d E C Gs. ( P A C L 
0 6 Fe b 2 0 2 4 )
T his c ha n ge is d ue t o 
l o gistical c halle n ges 
wit h ti mi n g of 
c ollecti o n f or 
la b orat or y tests, vital 
si g ns a n d E C Gs
Secti o n 8. 3. 2. 1 Bl o o d 
Press ure a n d P ulse Rate
Secti o n 8. 3. 3. 
Electr ocar di o gra ms
T he E mer ge nc y  C o ntact Car d is
bei n g re place d b y a st u d y
i nf or mati o n car d a n d will n o
l o n ger be refere nce d. ( P A C L 
0 2 A pr 2 0 2 4)
T he pr ocess f or 
c o ntacti n g a me dicall y 
q ualifie d i n di vi d ual 
has c ha n ge d fr o m a 
me dical escalati o n 
pr ocess via a Pfizer 
Call Ce nter t o direct 
cli nical tea m c o ntact 
usi n g a St u d y Tea m 
C o ntact L ist. 
Ta ble 1: Sc he d ule of 
Assess me nts
Secti o n 1 0. 1. 1 2 
S p o ns or’s Me dicall y 
Q ualifie d I n di vi d ual
A p pe n di x 1 6:
A b bre viati o ns
E dit orial a n d f or matti n g
c ha n ges a n d clarificati o ns
F or d oc u me nt 
acc urac y
a n d c o nsiste nc y.
T hr o u g h o ut t he 
d oc u me nt
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6
T A B L E O F C O N T E N T S
LI S T O F T A B L E S ...................................................................................................................1 3
LI S T O F FI G U R E S .................................................................................................................1 3
1. P R O T O C O L  S U M M A R Y...................................................................................................1 4
1. 1. S y n o psis ..................................................................................................................1 4
1. 2. Sc he ma ....................................................................................................................2 2
1. 3. Sc he d ule of Acti vities .............................................................................................2 3
2. I N T R O D U C TI O N ...............................................................................................................3 7
2. 1. St u d y  Rati o nale.......................................................................................................3 9
2. 2. Bac k gr o u n d .............................................................................................................3 9
2. 2. 1. Dr u g Mec ha nis m of Acti o n -
P F - 0 7 9 0 1 8 0 1...............................................3 9
2. 2. 2. N o ncli nical O ver vie w of P F - 0 7 9 0 1 8 0 1...................................................... 4 0
2. 2. 3. Cli nical O ver vie w .......................................................................................4 1
2. 2. 3. 1. Cli nical Safet y ...........................................................................4 1
2. 2. 3. 2. Cli nical Acti vit y ........................................................................4 2
2. 2. 3. 3. Cli nical P har mac ol o g y ..............................................................4 3
2. 3. Be nefit/ Ris k Assess me nt................................ .........................................................4 5
2. 3. 1. Ris k Assess me nt......................................................................................... 4 6
2. 3. 2. Be nefit Assess me nt .....................................................................................5 0
2. 3. 3. O verall Be nefit/ Ris k C o ncl usi o n ................................................................5 0
3. O BJ E C TI V E S, E N D P OI N T S, A N D E S TI M A N D S........................................................... 5 1
4. S T U D Y D E SI G N .................................................................................................................5 4
4. 1. O verall Desi g n .........................................................................................................5 4
4. 2. Scie ntific Rati o nale f or St u d y  Desi g n.....................................................................5 5
4. 2. 1. Di versit y  of St u d y P o p ulati o n ....................................................................5 5
4. 2. 2. D ose Le vel Re vie w Meeti n g ...................................................................... 5 5
4. 2. 3. C h oice of C o ntrace pti o n/ Barrier Re q uire me nts .........................................5 5
4. 2. 4. C ollecti o n of Retai ne d Researc h Sa m ples ..................................................5 6
4. 3. J ustificati o n f or D ose ..............................................................................................5 6
4. 3. 1. D osi n g Re gi me ns of P F- 0 7 9 0 1 8 0 1............................................................. 5 6
4. 3. 2. D osi n g re gi me n of Tafasita ma b a n d Le nali d o mi de ....................................5 6
4. 3. 3. Criteria f or D ose Escalati o n........................................................................ 5 7
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7
4. 3. 4. D ose L i miti n g T o xicit y Defi niti o n.............................................................5 8
4. 3. 4. 1. He mat ol o gical D L Ts .................................................................5 8
4. 3. 4. 2. N o n - He mat ol o gic D L Ts............................................................ 5 9
4. 3. 5. Ma xi m u m T olerate d D ose ..........................................................................5 9
4. 4. E n d of St u d y  Defi niti o n ..........................................................................................5 9
5. S T U D Y P O P U L A T I ON................................ ......................................................................5 9
5. 1. I n c l usi o n Criteria.....................................................................................................6 0
5. 2. E xcl usi o n Criteria ....................................................................................................6 2
5. 3. L ifest yle C o nsi derati o ns..........................................................................................6 4
5. 3. 1. C o ntrace pti o n ..............................................................................................6 4
5. 3. 2. P h ot ose nsiti vit y ...........................................................................................6 5
5. 4. Scree n Fail ures ........................................................................................................6 5
6. S T U D Y I N T E R V E N TI O N( S) A N D C O N C O MI T A N T T H E R A P Y .................................6 5
6. 1. St u d y  Inter ve nti o n(s) A d mi nistere d ........................................................................6 5
6. 1. 1. A d mi nistrati o n ............................................................................................6 7
6. 1. 1. 1. P F - 0 7 9 0 1 8 0 1............................................................................. 6 8
6. 1. 1. 2. Tafasita ma b ...............................................................................6 8
6. 1. 1. 3. Le nali d o mi de................................ .............................................6 9
6. 2. Pre parati o n, Ha n dli n g, St ora ge a n d Acc o u nta bilit y ................................................7 0
6. 2. 1. Pre parati o n a n d Dis pe nsi n g ........................................................................7 1
6. 3. Assi g n me nt t o St u d y I nter ve nti o n ...........................................................................7 1
6. 4. Bli n di n g................................ ...................................................................................7 2
6. 5. St u d y  Inter ve nti o n C o m plia nce ...............................................................................7 2
6. 6. D ose M o dificati o n ...................................................................................................7 3
6. 6. 1. D ose -M o dificati o n G ui deli nes ....................................................................7 3
6. 6. 2. Re -Treat me nt After T o xicit y ......................................................................8 1
6. 7. C o nti n ue d Access t o St u d y  Inter ve nti o n After t he E n d of t he St u d y ......................8 1
6. 8. Treat me nt of O ver d ose................................ ............................................................8 2
6. 9. Pri or a n d C o nc o mita nt T hera p y................................ ..............................................8 2
6. 9. 1. Pr o hi bite d I n hi bit ors/I n d ucers ....................................................................8 2
6. 9. 1. 1. P F - 0 7 9 0 1 8 0 1.............................................................................8 2
6. 9. 1. 2. Tafasita ma b ...............................................................................8 2
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8
6. 9. 1. 3. Le nali d o mi de .............................................................................8 2
6. 9. 2. Ot her Pr o hi bite d a n d/ o r Li mite d Use of A nti-T u m or/ A nt i-Ca ncer or 
E x peri me ntal Dr u gs or Pr oce d ures ..................................................................8 3
6. 9. 3. S u p p orti ve Care ..........................................................................................8 3
6. 9. 4. He mat o p oietic Gr o wt h Fact ors a n d Bl o o d Pr o d uct Tra nsf usi o ns ..............8 4
6. 9. 5. C ortic oster oi ds............................................................................................ 8 4
6. 9. 6. I nfecti o n P r o p hyl a xis a n d V acci nes ...........................................................8 5
6. 9. 7. S ur ger y ........................................................................................................8 5
6. 9. 8. Ra di ot hera p y............................................................................................... 8 5
7. DI S C O N T I N U A TI O N O F S T U D Y I N T E R V E N TI O N A N D P A RTI CI P A N T 
DI S C O N TI N U A TI O N/ WI T H D R A W A L ...........................................................................8 5
7. 1. Disc o nti n uati o n of St u d y  Inter ve nti o n ....................................................................8 5
7. 1. 1. C O VI D - 1 9 ..................................................................................................8 6
7. 2. Partici pa nt Disc o nti n uati o n/ Wit h dra wal Fr o m t he St u d y .......................................8 6
7. 2. 1. Wit h dra wal of C o nse nt ...............................................................................8 7
7. 3. L ost t o F oll o w -U p ...................................................................................................8 7
8. S T U D Y A S S E S S M E N T S A N D P R O C E D U R E S ...............................................................8 7
8. 1. A d mi nistrati ve Pr oce d ures ......................................................................................8 7
8. 1. 1. Scree ni n g a n d Baseli ne Pr oce d ures................................ ............................8 8
8. 1. 2. F oll o w -U p Visits a n d L T F U .......................................................................8 8
8. 2. Efficac y  Assess me nts..............................................................................................8 9
8. 2. 1. C o m p ute d T o m o gra p h y  Sca ns....................................................................9 0
8. 2. 2. P ositr o n E missi o n T o m o gra p h y Sca ns .......................................................9 1
8. 3. Safet y Assess me nts .................................................................................................9 1
8. 3. 1. P h y sical E xa mi nati o ns ................................................................................9 1
8. 3. 2. Vital Si g ns ..................................................................................................9 1
8. 3. 2. 1. B l o o d Press ure a n d P ulse Rate..................................................9 2
8. 3. 2. 2. Te m perat ure a n d Res pirat or y  Rate............................................9 2
8. 3. 3. Electr ocar di o gra ms..................................................................................... 9 2
8. 3. 4. Cli nical Safet y  La b orat or y Assess me nts....................................................9 3
8. 3. 4. 1. Alter nati ve Facilities f or Cli nical Safet y  La b orat or y 
Assess me nt ........................................................................................9 4
8. 3. 5. Pre g na nc y  Testi n g ......................................................................................9 4
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9
8. 3. 6. B- S y m pt o ms ...............................................................................................9 4
8. 4. A d verse E ve nts, Seri o us A d verse E ve nts, a n d Ot her Safet y Re p orti n g ................. 9 4
8. 4. 1. Ti me Peri o d a n d Fre q ue nc y  f or C ollecti n g A E a n d S A E I nf or mati o n....... 9 5
8. 4. 1. 1. Re p orti n g S A Es t o Pfizer Safet y ............................................... 9 6
8. 4. 1. 2. Rec or di n g N o nseri o us A Es a n d S A Es o n t he C R F ................... 9 6
8. 4. 2. Met h o d of Detecti n g A Es a n d S A Es .......................................................... 9 6
8. 4. 3. F oll o w -U p of A Es a n d S A Es ...................................................................... 9 6
8. 4. 4. Re g ulat or y  Re p orti n g Re q uire me nts f or S A Es........................................... 9 7
8. 4. 5. E n vir o n me ntal E x p os ure, E x p os ure D uri n g Pre g na nc y  or 
Breastfee di n g, a n d Occ u pati o nal E x p os ure ..................................................... 9 7
8. 4. 5. 1. E x p os ure D uri n g Pre g na nc y ...................................................... 9 7
8. 4. 5. 2. E x p os ure D uri n g Breastfee di n g ................................................ 9 9
8. 4. 5. 3. Occ u pati o nal E x p os ure ............................................................. 9 9
8. 4. 6. Car di o vasc ular a n d Deat h E ve nts .............................................................1 0 0
8. 4. 7. Disease -Relate d E ve nts a n d/ or Disease -Relate d O utc o mes N ot 
Q ualif yi n g as A Es or S A Es ............................................................................ 1 0 0
8. 4. 8. A d verse E ve nts of S pecial I nteres t........................................................... 1 0 0
8. 4. 8. 1. Lac k of Efficac y ...................................................................... 1 0 0
8. 4. 9. Me dical De vice Deficie ncies .................................................................... 1 0 0
8. 4. 1 0. Me dicati o n Err ors ................................................................................... 1 0 0
8. 5. P har mac o ki netics .................................................................................................. 1 0 1
8. 6. G e netics ................................................................................................................. 1 0 2
8. 6. 1. S pecifie d Ge netics .................................................................................... 1 0 2
8. 6. 2. Retai ne d Researc h Sa m ples f or Ge netics ................................................. 1 0 2
8. 7. Bi o mar kers ............................................................................................................ 1 0 2
8. 7. 1. Bl o o d Sa m ple f or Circ ulati n g Bi o mar ker A nal y sis .................................. 1 0 3
8. 7. 2. Bl o o d Sa m ple f or C D 4 7 Rece pt or Occ u pa nc y  A nalys is.......................... 1 0 3
8. 7. 3. Bl o o d Sa m ple f or
........................................1 0 3
8. 7. 4. Bl o o d Sa m ple f or
.................................................1 0 3
8. 7. 5. Bl o o d Sa m ple f or S pecifie d Ge netic Researc h......................................... 1 0 4
8. 7. 6. 
Sa m ple f or Matc he d C o ntr ol a n d S pecifie d Ge netic Researc h .....1 0 4
8. 7. 7. Bl o o d Sa m ple f or
A nal y sis..............................1 0 4
8. 7. 8. T u m or Tiss ue f or Ge netic/ Bi o mar ker A nal y sis........................................ 1 0 4
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)
C CI
C CI
C CI
C CI

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0
8. 8. I m m u n o ge nicit y Assess me nts ...............................................................................1 0 5
8. 8. 1. A nti -P F -0 7 9 0 1 8 0 1 A nti b o d y  ( A D A) a n d Ne utralizi n g A nti-P F -
0 7 9 0 1 8 0 1 A nti b o d y  ( N A b)............................................................................1 0 5
8. 8. 2. A nti- Tafasita ma b A nti b o d y  ( A D A) a n d Ne utralizi n g A nti -
Tafasita ma b A nti b o d y ( N A b) ........................................................................1 0 6
8. 9. P har mac o d y na mics ................................................................................................1 0 6
9. S T A TI S TI C A L C O N SI D E R A TI O N S .............................................................................. 1 0 6
9. 1. Healt h Ec o n o mics .................................................................................................1 0 7
9. 2. Statistical H y p ot hesis ............................................................................................1 0 7
9. 2. 1. Pri mar y  Esti ma n ds....................................................................................1 0 7
9. 2. 1. 1. P hase 1 b Pri mar y  Esti ma n d.....................................................1 0 7
9. 2. 1. 2. P hase 2 Pri mar y  Esti ma n d.......................................................1 0 8
9. 3. A nal y sis Sets .........................................................................................................1 0 8
9. 4. Statistical A nal y ses ...............................................................................................1 0 9
9. 4. 1. Ge neral C o nsi derati o ns .............................................................................1 0 9
9. 4. 2. Pri mar y  E n d p oi nts/ A nal ysis .....................................................................1 0 9
9. 4. 2. 1. P hase 1 b ...................................................................................1 0 9
9. 4. 2. 2. P hase 2 .....................................................................................1 0 9
9. 4. 3. Sec o n dar y  E n d p oi nts/ A nal ysis .................................................................1 1 0
9. 4. 3. 1. Ef ficac y A nalys es ....................................................................1 1 0
9. 4. 3. 2. Safet y A nal ys es .......................................................................1 1 1
9. 4. 3. 3. P har mac o ki netic A nal y ses f or P F-0 7 9 0 1 8 0 1 ..........................1 1 2
9. 4. 3. 4. I m m u n o ge nicit y A nal y ses f or P F-0 7 9 0 1 8 0 1 ..........................1 1 2
9. 4. 4. Tertiar y / E x pl orat or y E n d p oi nt(s) A nalys is ..............................................1 1 2
9. 4. 5. Ot her Safet y A nal yses ..............................................................................1 1 3
9. 4. 5. 1. Electr ocar di o gra m A nal y ses....................................................1 1 3
9. 4. 6. Ot her A nal ys es ..........................................................................................1 1 3
9. 5. I nteri m A nal ys es ...................................................................................................1 1 3
9. 6. Sa m ple Size Deter mi nati o n ...................................................................................1 1 3
9. 7. Statistical Met h o ds a n d Decisi o n Criteria................................ .............................1 1 5
1 0. S U P P O R TI N G D O C U M E N T A TI O N A N D O P E R A TI O N A L 
C O N SI D E R A TI O N S................................ ........................................................................1 1 7
1 0. 1. A p pe n di x 1: Re g ulat or y , Et hical, a n d St u d y O versi g ht C o nsi derati o ns.............1 1 7
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1
1 0. 1. 1. Re g ulat or y  a n d Et hical C o nsi derati o ns ..................................................1 1 7
1 0. 1. 1. 1. Re p orti n g of Safet y  Iss ues a n d Seri o us Breac hes of t he 
Pr ot oc ol or I C H G C P .......................................................................1 1 7
1 0. 1. 2. Fi na ncial Discl os ure ...............................................................................1 1 8
1 0. 1. 3. I nf or me d C o nse nt/ Asse nt Pr ocess ..........................................................1 1 8
1 0. 1. 4. Data Pr otecti o n .......................................................................................1 1 9
1 0. 1. 5. C o m mittees Str uct ure .............................................................................1 1 9
1 0. 1. 6. Disse mi nati o n of Cli nical St u d y  Data ....................................................1 2 0
1 0. 1. 7. Data Q ualit y Ass ura nce ..........................................................................1 2 1
1 0. 1. 8. S o urce D oc u me nts ..................................................................................1 2 2
1 0. 1. 9. Use of Me dical Rec or ds ..........................................................................1 2 2
1 0. 1. 1 0. St u d y  a n d Site Start a n d Cl os ure ..........................................................1 2 3
1 0. 1. 1 1. P u blicati o n P olic y .................................................................................1 2 4
1 0. 1. 1 2. S p o ns or’s Me dicall y  Q ualifie d I n di vi d ual............................................1 2 5
1 0. 2. A p pe n di x 2: Cli nical La b orat or y  Assess me nts...................................................1 2 6
1 0. 3. A p pe n di x 3: A d verse E ve nts: Defi niti o ns a n d Pr oce d ures f or Rec or di n g, 
E val uati n g, F oll o w -U p, a n d Re p orti n g ...................................................................1 2 8
1 0. 3. 1. Defi niti o n of A E .....................................................................................1 2 8
1 0. 3. 2. Defi ni ti o n of a n S A E..............................................................................1 2 9
1 0. 3. 3. Rec or di n g/ Re p orti n g a n d F oll o w- U p of A Es a n d/ or S A Es D uri n g 
t he Acti ve C ollecti o n Peri o d..........................................................................1 3 1
1 0. 3. 4. Re p orti n g of S A Es.................................................................................. 1 3 4
1 0. 4. A p pe n di x 4: C o ntrace pti ve a n d Barrier G ui da nce ..............................................1 3 5
1 0. 4. 1. Male Partici pa nt Re pr o d ucti ve I ncl usi o n Criteria.................................. 1 3 5
1 0. 4. 2. Fe male Partici pa nt Re pr o d ucti ve I n cl usi o n Criteria ...............................1 3 5
1 0. 4. 3. W o ma n of C hil d beari n g a n d N o n - C hil d beari n g P ote ntial .....................1 3 6
1 0. 4. 4. C o ntrace pti o n Met h o ds ...........................................................................1 3 7
1 0. 4. 5. Le nali d o mi de Pre g na nc y  Pre ve nti o n Pr o gra m....................................... 1 3 8
1 0. 5. A p pe n di x 5: Ge netics................................ ..........................................................1 4 2
1 0. 6. A p pe n di x 6: L i ver Safet y: S u g geste d Acti o ns a n d F oll o w-U p Assess me nts .....1 4 3
1 0. 7. A p pe n di x 7: Ki d ne y  Safet y: M o nit ori n g G ui deli nes ..........................................1 4 5
1 0. 7. 1. La b orat or y  Assess me nt of C ha n ge i n Ki d ne y F u ncti o n a n d 
Detecti o n of Ki d ne y  Inj ur y ............................................................................1 4 5
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 2
1 0. 7. 2. A ge -S pecific Ki d ne y  F u ncti o n Calc ulati o n Rec o m me n dati o ns.............1 4 6
1 0. 7. 2. 1. A d ults ( 1 8 Years a n d A b o ve) — 2 0 2 1 C K D - E PI 
E q uati o ns......................................................................................... 1 4 6
1 0. 7. 3. A d verse E ve nt Gra di n g f or Ki d ne y  Safety La b orat or y  
A b n or malities .................................................................................................1 4 6
1 0. 8. A p pe n di x 8: E C G Fi n di n gs of P ote ntial Cli nical C o ncer n .................................1 4 7
1 0. 9. A p pe n di x 9: Pr o hi bite d C o nc o mita nt Me dicati o ns T hat Ma y  Res ult i n D DI.....1 4 9
1 0. 1 0. A p pe n di x 1 0: C o u ntr y -S pecific Re q uire me nts .................................................1 5 0
1 0. 1 0. 1. Fra nce ...................................................................................................1 5 0
1 0. 1 0. 2. Ja pa n .....................................................................................................1 5 0
1 0. 1 1. A p pe n di x 1 1: L u ga n o M o dificati o n of A n n Ar b or Sta gi n g S ys te m (f or 
Pri mar y  N o dal L ym p h o mas) ...................................................................................1 5 4
1 0. 1 2. A p pe n di x 1 2: L u ga n o Criteria ...........................................................................1 5 5
1 0. 1 3. A p pe n di x 1 3: E C O G Perf or ma nce Stat us .........................................................1 5 6
1 0. 1 4. A p pe n di x 1 4: I nter nati o nal Pr o g n ostic I n de x (IPI )...........................................1 5 7
1 0. 1 5. A p pe n di x 1 5: Pr ot oc ol A me n d me nt Hist or y .....................................................1 5 8
1 0. 1 6. A p pe n di x 1 6: A b bre viati o ns .............................................................................1 6 3
1 1. R E F E R E N C E S ................................................................................................................1 6 9
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 3
LI S T O F T A B L E S
Ta ble 1.
St u d y  Sc he d ule of Assess me nt.................................................................2 3
Ta ble 2.
Cli nical Acti vit y  wit h P F - 0 7 9 0 1 8 0 1 M o n ot hera p y at D oses 
Ra n gi n g fr o m 0. 8 -1 8 m g/ k g - St u d y  C 4 9 7 1 0 0 1 (as of 1 2 A pril 
2 0 2 1)......................................................................................................... 4 2
Ta ble 3.
Pr o visi o nal D ose Le vels P F - 0 7 9 0 1 8 0 1 i n D ose-Escalati o n .....................5 7
Ta ble 4.
St u d y  Inter ve nti o n(s) - I M P......................................................................6 5
Ta ble 5.
St u d y  Inter ve nti o ns Classifie d as NI M Ps/ A x M Ps ....................................6 7
Ta ble 6.
D ose M o dificati o ns f or Relate d He mat ol o gic T o xicities .........................7 5
Ta ble 7.
D ose M o dificati o ns f or N o n -He mat ol o gic T o xicities ..............................7 7
Ta ble 8.
D ose M o dificati o ns f or Le nali d o mi de T o xicities .....................................7 9
Ta ble 9.
D ose M o dificati o ns f or I nf usi o n-Relate d Reacti o ns ................................8 0
Ta ble 1 0.
Re d ucti o ns f or Le nali d o mi de ...................................................................8 1
Ta ble 1 1.
Sa m ple Size a n d 9 5 % CI f or O R R base d o n Wils o n M et h o d ( wit h 
C o nti n uit y  C orrecti o n)............................................................................1 1 5
Ta ble 1 2.
m T PI -2 Decisi o n R ules ( p T = 0. 3, e 1 = 0. 0 5, e 2 = 0. 0 5) .............................1 1 6
Ta ble 1 3.
St u d y -S pecific Cli nical La b orat or y  Assess me nts...................................1 2 6
LI S T O F FI G U R E S
Fi g ure 1.
P F -0 7 9 0 1 8 0 1 Str uct ure a n d Mec ha nis m of Acti o n ..................................3 9
Fi g ure 2.
P F -0 7 9 0 1 8 0 1 Bi n ds Mi ni mall y t o H u ma n Re d Bl o o d Cells ....................4 0
Fi g ure 3.
I n Vitr o a n d I n Vi v o A nti-T u m or Acti vit y  of P F-0 7 9 0 1 8 0 1 ....................4 1
Fi g ure 4.
Pre g na nc y  Pre ve nti o n Pla n Al g orit h m ...................................................1 4 1
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 4
1. P R O T O C O L S U M M A R Y 
1. 1. S y n o psis 
Pr ot oc ol Title: 
A P hase 1 b/ 2 st u d y  of P F- 0 7 9 0 1 8 0 1, a C D 4 7 bl oc ki n g a ge nt, wit h tafasita ma b a n d 
le nali d o mi de f or partici pa nts wit h rela pse d/refract or y diff use lar ge B cell l y m p h o ma n ot 
eli gi ble f or ste m cell tra ns pla ntati o n
Brief Title: 
P hase 1 b/ 2 st u d y  of P F -0 7 9 0 1 8 0 1, tafasita ma b, a n d le nali d o mi de i n tra ns pla nt i neli gi ble 
rela pse d/refract or y diff use lar ge B cell l ym p h o ma partici pa nts
Re g ul at or y A ge nc y I de ntific ati o n N u m ber(s):
U S I N D N u m ber:
I N D 1 3 5 4 2 1
E U C T N u m ber:
N A
Cli nic al Tri als. g o v I D:
N C T 0 5 6 2 6 3 2 2
Pe di atric I n vesti g ati o n al Pl a n N u m ber:
N ot a p plica ble
Pr ot oc ol N u m ber:
C 4 9 7 1 0 0 3
P h ase:
1 b/ 2
R ati o n ale:
T he p ur p ose of t his P hase 1 b/ 2 st u d y  is t o e val uate t he safet y, t olera bilit y a n d p ote ntial 
cli nical be nefits of P F - 0 7 9 0 1 8 0 1 i n c o m bi nati o n wit h sta n dar d d oses of tafasita ma b a n d 
le nali d o mi de i n partici pa nts wit h rela pse d-refract or y diff use lar ge B cell ly m p h o ma ( R/ R 
D L B C L) n ot eli gi ble f or hi g h d ose c he m ot hera p y f oll o we d by a ut ol o g o us ste m cell 
tra ns pla ntati o n ( A S C T).  
A b usi ness decisi o n was ma de b y Pfizer t o ter mi nate t he C 4 9 7 1 0 0 3 st u d y. T he reas o n f or 
st u d y ter mi nati o n is n ot d ue t o a n y safet y c o ncer ns or re q uests fr o m re g ulat or y  a ut h orities. 
As a res ult of t his decisi o n, P hase 1 b will be disc o nti n ue d after t he last partici pa nt last visit 
a n d P hase 2 of t he st u d y will n ot be i nitiate d.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 5
O bjecti ves, E n d p oi nts, a n d Esti m a n ds:
P H A S E 1 b
O bjecti ves
E n d p oi nts
Esti m a n ds
Pri m ar y
T o assess d ose li miti n g t o xicit y ( D L Ts), 
safet y a n d t olera bilit y of P F-0 7 9 0 1 8 0 1 i n 
c o m bi nati o n wit h tafasita ma b a n d 
le nali d o mi de i n a d ult partici pa nts wit h R/ R 
D L B C L i n or der t o select u p t o 2 d oses of P F -
0 7 9 0 1 8 0 1 f or f urt her e val uati o n i n P hase 2 of 
t he st u d y.
D L Ts d uri n g t he D L T o bser vati o n peri o d ( 2 8 
da ys f oll o wi n g C 1 D 1).
D L T rate esti mate d base d o n data fr o m D L T -e val ua ble 
partici pa nts d uri n g t he D L T o bser vati o n peri o d ( 2 8 da ys 
f oll o wi ng C 1 D 1).
Sec o n d ar y 
T o e val uate t he o verall safet y pr ofile of t he 
c o m bi nati o n.

A d verse e ve nts ( A E s) as c haracterize d b y 
t ype, fre q ue nc y, se verit y (as gra de d b y 
Nati o nal Ca ncer I nstit ute C o m m o n 
Ter m i n ol o g y Criteria f or A d verse E ve nts 
[ N CI C T C A E] v 5. 0), ti mi n g, seri o us ness, a n d 
relati o ns hi p t o st u d y treat me nt.

La b orat or y a b n or malities as c haracterize d b y 
t ype, fre q ue nc y, se verit y (as gra de d b y N CI 
C T C A E v 5. 0), a n d ti mi n g.
N ot A p plica ble
T o e val uate t he a nti-t u m or acti vit y of 
P F -0 7 9 0 1 8 0 1 i n c o m bi nati o n wi t h tafasita ma b 
a n d le nali d o mi de.
O bjecti ve res p o nse ( O R), d urati o n of res p o nse 
( D o R), c o m plete res p o nse ( C R), d urati o n of 
c o m plete res p o nse ( D o C R), a n d pr o gressi o n -free 
s ur vi val ( P F S) per L u ga n o Res p o nse 
Classificati o n Criteria 2 0 1 4 as assesse d b y t he 
i n vesti gat or.
N ot a p plica ble
T o e val uate t he p har mac o ki netics ( P K) of 
P F -0 7 9 0 1 8 0 1.
Pre - a n d p ost-d ose c o nce ntrati o n of P F -0 7 9 0 1 8 0 1.
N ot a p plica ble
T o e val uate i m m u n o ge nicit y of P F -0 7 9 0 1 8 0 1.
A nti dr u g a nti b o dies ( A D As) a n d ne utralizi n g 
a nti b o dies ( Na bs) a gai nst P F -0 7 9 0 1 8 0 1.
N ot a p plica ble
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 6
P H A S E 2 
O bjecti ves
E n d p oi nts
Esti m a n ds
Pri m ar y
T o assess t he cli nical a nti -t u m or acti vit y of 
P F -0 7 9 0 1 8 0 1 i n c o m bi nati o n wit h tafasita ma b 
a n d le nali d o mi de.
O R per L u ga n o Res p o nse Classificati o n Criteria 
2 0 1 4 as assesse d b y t he i n vesti gat or.
T he treat me nt effect of P F -0 7 9 0 1 8 0 1 i n c o m bi nati o n 
wit h tafasita ma b a n d le nali d o mi de o n O R per t he 
L u ga n o 2 0 1 4 res p o nse criteria as deter mi ne d b y 
i n vesti gat or assess me nt fr o m t he date of first d ose u ntil 
t he first d oc u me ntati on of P D, deat h, or start of ne w  
a ntica ncer t hera p y. Partici pa nts w h o d o n ot ha ve a p ost -
baseli ne disease assess me nt d ue t o earl y P D, w h o 
recei ve a ntica ncer t hera pies ot her t ha n t he st u d y 
i nter ve nti o n pri or t o ac hie vi n g a n o bjecti ve res p o nse, or 
w h o die, e x perie nce P D, or st o p disease assess me nts f or 
a n y reas o n pri or t o ac hie vi n g a n o bjecti ve res p o nse will 
be c o u nte d as n o n -res p o n ders.
Sec o n d ar y
T o assess a d diti o nal efficac y o utc o mes of P F -
0 7 9 0 1 8 0 1 i n c o m bi nati o n wit h tafasita ma b 
a n d le nali d o mi de.
D o R, C R, D o C R a n d P F S b y i n vesti gat or per 
L u ga n o Res p o nse Classificati o n Criteria 2 0 1 4.
N ot a p plica ble
Select t he R P 3 D f or P F -0 7 9 0 1 8 0 1 i n 
c o m bi nati o n wit h tafasita ma b a n d 
le nali d o mi de.
All e n d p oi nts i n t his st u d y.
N ot a p plica ble
T o f urt her e val uate t he o verall safet y pr ofile 
a n d t olera bilit y of P F -0 7 9 0 1 8 0 1 i n 
c o m bi nati o n wit h tafasita ma b a n d 
le nali d o mi de.

A E s as c haracterize d b y t y pe, fre q ue nc y, 
se verit y (as gra de d b y N CI C T C A E v 5. 0), 
ti mi n g, seri o us ness, a n d relati o ns hi p t o st u d y 
treat me nt.

La b orat or y a b n or mali ties as c haracterize d b y 
t ype, fre q ue nc y, se verit y (as gra de d b y N CI 
C T C A E v 5. 0), a n d ti mi n g.
N ot a p plica ble
T o e val uate t he P K of P F -0 7 9 0 1 8 0 1.
Pre - a n d p ost-d ose c o nce ntrati o ns of 
P F -0 7 9 0 1 8 0 1.
N ot a p plica ble
T o e val uate i m m u n o ge nicit y of P F -0 7 9 0 1 8 0 1 .
A D As a n d N A bs a gai nst P F -0 7 9 0 1 8 0 1 .
N ot a p plica ble 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 7
O ver all Desi g n
T his is a m ultice nter, i nter nati o nal, P hase 1 b/ 2 st u d y  of differe nt d oses of P F-0 7 9 0 1 8 0 1 i n 
c o m bi nati o n wit h tafasita ma b a n d le nali d o mi de i n partici pa nts wit h R/ R D L B C L  w h o ha ve 
c o m plete d at least 1 li ne of s yste mic treat me nt (at least 1 c o ntai ni n g a n a nti-C D 2 0 t hera p y), 
a n d w h o are n ot ca n di dates f or hi g h d ose t hera p y/ A S C T .
A n escalati o n/ de -escalati o n a p pr oac h will be use d i n P hase 1 b t o deter mi ne t he P F - 0 7 9 0 1 8 0 1 
rec o m me n de d P hase 2 d ose ( R P 2 D) ( 2 d ose le vels) i n c o m bi nati o n wit h tafasita ma b a n d 
le nali d o mi de; t he t w o d ose le vels will be f urt her e val uate d i n P hase 2. 
N u m ber of P artici p a nts
A p pr o xi matel y  7 0 partici pa nts will be e nr olle d i n t he st u d y: a p pr o xi matel y 2 0 partici pa nts i n 
t he P hase 1 b a n d 5 0 partici pa nts i n t he P hase 2.
N ote: " E nr olle d" mea ns a partici pa nt's, or t heir le gall y a ut h orize d re prese ntati ve’s, a gree me nt 
t o partici pate i n a cli nical st u d y f oll o wi n g c o m pleti o n of t he i nf or me d c o nse nt pr ocess a n d 
assi g n me nt t o st u d y i nter ve nti o n. 
St u d y P o p ul ati o n 
A d ult partici pa nts ( ≥1 8 years of a ge) wit h hist ol o gicall y  c o nfir me d meas ura ble rela pse d or 
refract or y D L B C L n ot eli gi ble f or ste m cell tra ns pla ntati o n will be e nr olle d i n t he st u d y. 
Ke y I ncl usi o n Criteri a

Hist ol o gicall y c o nfir me d D L B C L; rela pse d or refract or y disease.

Partici pa nt is n ot a ca n di date f or or is u n willi n g t o u n der g o hi g h d ose c he m ot hera p y 
a n d s u bse q ue nt ste m cell tra ns pla nt or is u na ble t o recei ve a p pr o ve d c hi meric a nti ge n 
rece pt or ( C A R-T) t her a p y.

Pri or treat me nt wit h at least 1 li ne of s y ste mic t hera p y (f or p hase 2: at least 1 a n d n o 
m ore t ha n 2 li nes of s ys te mic t hera py) . Pri or t hera p y m ust i ncl u de a n a nti-C D 2 0 
c o ntai ni n g re gi me n.

A de q uate he mat ol o gic, he patic a n d re nal f u ncti o n. 

Easter n C o o perati ve O nc ol o g y  Gr o u p ( E C O G) perf or ma nce stat us ≤2.

Partici pa nts are a ble t o pr o vi de a t u m or tiss ue sa m ple c ollecte d bef ore start of 
treat me nt (fres h or arc hi val).  
Ke y E xcl usi o n Criteri a 

Pri or treat me nt wit h a n a nti- C D 4 7 or a nti -C D 1 9 ( ot her t ha n C A R -T) or 
i m m u n o m o d ulat or y a ge nts.  
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 8

Pri mar y  refract or y D L B C L 

Hi g h -gra de l y m p h o ma (f or merl y k n o w n as ‘ d o u ble’ or ‘tri ple hit’ D L B C L) or C N S 
l ym p h o ma i n v ol ve me nt.  

Pri or all o ge neic ste m cell tra ns pla ntati o n; a ut ol o g o us ste m cell tra ns pla ntati o n wit hi n 
1 2 wee ks pri or t o e nr o ll me nt.

Si g nifica nt car diac/car di o vasc ular/t hr o m b oe m b olic disease.  

Partici pa nts wit h acti ve, u nc o ntr olle d bacterial, f u n gal, or viral i nfecti o n. 
St u d y Ar ms a n d D ur ati o n St u d y I nter ve nti o n(s)
I nter ve nti o n N a me
P F -0 7 9 0 1 8 0 1
T af asit a m a b
Le n ali d o mi de
Ar m N a me
( gr o u p of p artici p a nts recei vi n g a 
s pecific tre atme nt or n o tre at me nt)
A d mi nistere d t o all 
partici pa nts 
A d mi nistere d t o all 
partici pa nts
A d mi nistere d t o all 
partici pa nts 
U nit D ose Stre n gt h(s)
1 0 m g/ m L s ol uti o n 
f or i njecti o n; 1 4 
m L/ vial
2 0 0 m g/ vial
2. 5 m g, 5 m g, 1 0 m g, 
1 5 m g, 2 0 m g, 2 5 m g
R o ute of A d mi nistr ati o n
I ntra ve n o us (I V) 
i nf usi o n
I V i nf usi o n
B y  mo ut h ( P O)
Use
E x peri me ntal 
E x peri me ntal w he n 
c o m bi ne d wit h
P F -0 7 9 0 1 8 0 1 
E x peri me ntal w he n 
c o m bi ne d wit h 
P F -0 7 9 0 1 8 0 1 
I n vesti g ati o n al me dici n al pr o d uct (I M P) 
or n o n -I M P ( NI M P)/ a u xili ar y me dici n al 
pr o d uct ( A x M P)
I M P
I M P
I M P
D ose F or m ul ati o n 
Si n gle -use vials
Si n gle -use vials
Ca ps ules
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 9
St u d y I nter ve nti o ns Cl assifie d as NI M Ps/ A x M Ps
I nter ve nti o n 
N a me
Fl u de o x y gl uc
ose ( 1 8F) 
( F D G)
P ar acet a m ol a
Di p he n h y dr a m i ne 
h y dr oc hl ori de a .
Ci meti di ne a .
Met h yl pre d nis ol o ne
a.
A R M N a m e
( gr o u p of 
p artici p a nts 
recei vi n g a 
s pecific 
tre atme nt) 
Ma y be 
a d mi nistere d 
t o all 
partici pa nts 
f or use wit h 
P E T sca n
Ma y be 
a d mi nistere d 
t o all 
partici pa nts as 
pre me dicati o n
a
Ma y be 
a d mi nistere d t o all 
partici pa nts as 
pre me dicati o n a
Ma y be 
a d mi nistere d t o 
all partici pa nts 
as 
pre me dicati o n a
Ma y be a d mi nistere d 
t o all partici pa nts as 
pre me dicati o n a
D ose 
F or m ul ati o n
As per S m P C 
As per S m P C  
As per S m P C  
As per S m P C  
As per S m P C
U nit D ose 
Stre n gt h(s)
As per S m P C  
As per S m P C  
As per S m P C  
As per S m P C  
As per S m P C
R o ute of 
A d mi nistr ati o n
I V i njecti o n
P O
P O or I V
P O
I V i njecti o n or 
i nf usi o n
Use
F or use wit h 
P E T
Pre me dicati o n 
Pre me dicati o n 
Pre me dicati o n 
Pre me dicati o n
I M P or 
NI M P/ A x M P
A x M P  
A x M P  
A x M P
A x M P
A x M P
a.
Pre me dicati o ns t hat ma y be gi ve n as per MI NJ U VI S m P C [e q ui vale nt pre me dicati o n(s) i ncl u des variati o ns t o 
t he state d o nes, de pe n di n g o n t he f or m ulati o ns a vaila ble l ocall y a n d or i n acc or da nce wit h i nstit uti o nal g ui deli nes].
A d mi nistr ati o n
St u d y  i nter ve nti o ns will be a d mi nistere d i n 2 8-da y  c ycles. Le nali d o mi de will be a d mi nistere d 
u p t o C 1 2 w hile P F - 0 7 9 0 1 8 0 1 a n d tafasita ma b will be a d mi nistere d u ntil P D, n o n-t olera ble 
t o xicit y, or deat h. P F -0 7 9 0 1 8 0 1 will be a d mi nistere d b y  i ntra ve n o us (I V) i nf usi o n wee kly f or 
t he first t hree c ycles a n d t he n e ver y t w o wee ks f or C ycle 4 a n d be yo n d. Partici pa nts will 
recei ve differe nt d ose le vels as per assi g ne d c o h ort.   
Tafasita ma b will be a d mi nistere d 1 2 m g/ k g I V o n Da y s 1, 4, 8, 1 5 a n d 2 2 i n C ycle 1, wee kl y 
f or C ycle 2 a n d 3 a n d t he n e ver y 2 wee ks f or C ycle 4 a n d be yo n d.  Le nali d o mi de will be 
a d mi nistere d 2 5 m g P O dail y o n Da ys 1 t hr o u g h 2 1 of eac h 2 8-d a y  c ycle f or u p to 1 2 c ycles.
St atistic al Met h o ds: 
T here is n o f or mal h y p ot hesis testi n g f or t he st u dy. All a nal y ses will be perf or me d f or t he 
P hase 1 b a n d P hase 2 of t he st u d y  se paratel y. All efficac y a nalys es a n d safet y a nal yses will 
be perf or me d usi n g t he Safet y A nal y sis Set (if n ot ot her wise s pecifie d).
P h ase 1 b:
T he pri mar y  e n d p oi nt of t he P hase 1 b of t he st u dy is t he D LTs d uri n g t he D L T o bser vati o n 
peri o d . T he tar get n u m ber of partici pa nts per c o h ort is 2- 4, a n d a mi ni m u m of 
2 - 4 D L T -e val ua ble partici pa nts is re q uire d at eac h teste d d ose le vel of P F- 0 7 9 0 1 8 0 1. 
A p pr o xi matel y  6 t o 9 D L T-e val ua ble partici pa nts will be treate d at t he M T D or hi g hest safe 
teste d d ose le vel f or P F-0 7 9 0 1 8 0 1 bef ore pr ocee di n g t o P hase 2. T he n u m ber a n d pr o p orti o n 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 0
of partici pa nts e x perie nci n g D L Ts d uri n g t he D L T o bser vati o n peri o d will be s u m marize d 
a n d liste d b y d ose le vel.
P h ase 2:
U p t o 2 d oses will be selecte d f or f urt her e val uati o n i n P hase 2 of t he st u d y. A p pr o xi matel y  
2 5 partici pa nts will be treate d f or eac h selecte d d ose.
T he pri mar y  e n d poi nt i n t he P hase 2 of t he st u d y  is O R per L u ga n o Res p o nse Classificati o n 
Criteria 2 0 1 4 as assesse d b y  t he i n vesti gat or. O R is defi ne d as a B O R of C R or P R acc or di n g 
t o Lu ga n o Res p o nse Classificati o n Criteria 2 0 1 4.
O R R will be calc ulate d al o n g wit h t he 2 -si de d 9 5 % CI usi n g t he Wils o n met h o d.
F or b ot h p h ases :

Sec o n dar y  efficac y e n d p oi nts ( O R [ P hase 1 b o nl y], D o R, C R, D o C R, a n d P F S per 
L u ga n o Res p o nse Classificati o n Criteria 2 0 1 4 as assesse d b y  t he i n vesti gat or) will be 
s u m marize d b y d ose le vels.

Sec o n dar y  safety e n d p oi nts ( A Es, la b orat or y a b n or malities):
o
A Es will be gra de d b y t he i n vesti gat or acc or di n g t o t he C T C A E v 5. 0 a n d c o de d 
usi n g Me d D R A. A E data will be re p orte d i n ta bles a n d listi n gs a n d will be 
prese nte d b y d ose le vels.
o
T he la b orat or y  res ults will be gra de d acc or di n g t o t he N CI  C T C A E v 5. 0 se verit y 
gra de a n d will be a nal yz e d usi n g s u m mar y statistics.

Sec o n dar y  P K e n d p oi nts will be a nalyz e d a n d prese nte d usi n g descri pti ve s u m mar y  
statistics.

Sec o n dar y  i m m u n o ge nicit y ( A D As a n d Na bs): t he perce nta ge of partici pa nts wit h 
p ositi ve A D A will be s u m marize d. L isti n gs a n d s u m mar y ta b ulati o ns of t he A D A 
data at baseli ne a n d p ost -first d ose will be ge nerate d.
Et hic al C o nsi der ati o ns
Patie nts wit h R/ R D L B C L w h o are n ot ca n di dates f or A S C T d ue t o a ge or c o -m or bi dities 
ha ve li mite d treat me nt o pti o ns a n d p o or pr o g n osis. T he c o m bi nati o n of tafasita ma b a n d 
le nali d o mi de has s h o w n i ncrease d res p o nse a n d pr o gressi o n-free s ur vi val i n patie nts wit h 
R/ R D L B C L, lea di n g t o c o n diti o nal a p pr o val. B y  e n ga gi n g o verla p pi n g as well as differe nt 
mec ha nis ms wit h t he c o m bi nati o n of tafasita ma b a n d le nali d o mi de, P F -0 7 9 0 1 8 0 1 is e x pecte d 
t o i ncrease a nti-t u m or acti vit y i n patie nts wit h R/ R D L B C L. F urt her, a vaila ble safety data of 
P F -0 7 9 0 1 8 0 1 as a si n gle a ge nt i n patie nts wit h D L B C L  s u g gest t hat it ma y be c o m bi ne d wit h 
ot her a p pr o ve d a ge nts wit h o ut si g nifica ntl y i ncreasi n g t heir t o xicit y . P ossi ble o verla p pi n g 
t o xicit y wit h t he pr o p ose d re gi me ns i ncl u de ne utr o pe nia a n d t hr o m b oc yt o pe nia; t o mi ni mize 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 1
ris ks, partici pa nts will be m o nit ore d fre q ue ntly, i ncl u di n g wee kly bl o o d tests f or t heir first 8 
wee ks of treat me nt. 
T heref ore, ta ki n g i nt o c o nsi derati o n t he c o m ple me ntar y  mec ha nis ms of acti o n of P F-
0 7 9 0 1 8 0 1 wit h tafasita ma b a n d le nali d o mi de as well as t he safet y pr ofile of P F - 0 7 9 0 1 8 0 1, 
t his c o m bi nati o n ma y  offer a m ore efficaci o us a n d t olera ble treat me nt o pti o n f or ol der 
patie nts or patie nts wit h c o - m or bi dities t hat are n ot ca n di dates f or hi g h d ose c he m ot hera py 
a n d/ or A S C T.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 2
1. 2. Sc he m a
P hase 2 of t he st u d y will n ot be i nitiate d per b usi ness decisi o n ma de b y  Pfizer ( pr ot oc ol 
a me n d me nt 2) .
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 3
1. 3. Sc he d ule of Acti vities
T he S o A ta ble pr o vi des a n o ver vie w of t he pr ot oc ol visits a n d pr oce d ures. Refer t o t he S T U D Y A S S E S S M E N T S A N D 
P R O C E D U R E S secti o n of t he pr ot oc ol f or detaile d i nf or mati o n o n eac h assess me nt re q uire d f or c o m plia nce wit h t he pr ot oc ol. 
T he i n vesti gat or ma y  sc he d ule visits or tests ( u n pla n ne d visits/tests) i n a d diti o n t o t h ose liste d i n t he S o A ta ble, i n or der t o c o n d uct 
e val uati o ns or assess me nts re q uire d t o pr otect t he well- bei n g of t he partici pa nt.
T a ble 1 .
St u d y Sc he d ule of Assess me nt
Visit I de ntifier
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 6
O n -Tre at me nt Peri o d ( 2 8 -d a y C ycle)
N otes
Scree n
C ycle 1
C ycle 2 - 3
≥C ycle 4
E O T
F U visits
L T F U

All scree ni n g s h o ul d be d o ne ≤2 8 da ys bef ore t he 
first d ose, u nless n ote d ot her wise.
C ycle D a y
≤2 8 d
D 1
D 4
D 8
D 1 5
D 2 2
D 1
D 8
D 1 5
D 2 2
D 1
D 1 5
7 d
2 8 d
9 0 d
Q 1 2 W

Da y relati ve t o start of st u d y i nter ve nti o n 
( Da y 1).
Visit Wi n d o w
( ± 1 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ±2 d p ost -l ast 
T X )
( 2 8- 3 5 d p ost-
l ast T X)
( + 7 p ost-l ast 
T X )
( ± 1 4 d p ost 
9 0 d F U)

After 1 year of st u d y i nter ve nti o n, c ycle visit date 
wi n d o ws are ± 7 d.
Inf or me d c o nse nt 
X

C o nse nt o btai ne d wit hi n 2 8 da ys pri or t o C 1 D 1.

See Secti o n 1 0. 1. 3 f or a d diti o nal i nf or mati o n.
Re gistrati o n/ra n d o mizati o n  
X

At re gistrati o n, w hic h m ust be bef ore t he first 
st u d y-relate d acti vit y at D 1, t he partici pa nt 
e nr oll me nt n u m ber a n d d ose le vel all ocati o n are 
assi g ne d.

F or ra n d o mize d c o h orts: All ocati o n of 
partici pa nts t o treat me nt gr o u ps will pr ocee d 
t hr o u g h t he use of a n I R T S yste m. St u d y 
i nter ve nti o n m ust start prefera bl y t he sa me da y or 
wit hi n 3 da ys after ra n d o mizati o n.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 4
T a ble 1 .
St u d y Sc he d ule of Assess me nt
Visit I de ntifier
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 6
O n -Tre at me nt Peri o d ( 2 8 -d a y C ycle)
N otes
Scree n
C ycle 1
C ycle 2 - 3
≥C ycle 4
E O T
F U visits
L T F U

All scree ni n g s h o ul d be d o ne ≤2 8 da ys bef ore t he 
first d ose, u nless n ote d ot her wise.
C ycle D a y
≤2 8 d
D 1
D 4
D 8
D 1 5
D 2 2
D 1
D 8
D 1 5
D 2 2
D 1
D 1 5
7 d
2 8 d
9 0 d
Q 1 2 W

Da y relati ve t o start of st u d y i nter ve nti o n 
( Da y 1).
Visit Wi n d o w
( ± 1 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ±2 d p ost -l ast 
T X )
( 2 8- 3 5 d p ost-
l ast T X)
( + 7 p ost-l ast 
T X )
( ± 1 4 d p ost 
9 0 d F U)

After 1 year of st u d y i nter ve nti o n, c ycle visit date 
wi n d o ws are ± 7 d.
Disease 
c haracteristics/treat me nt 
hist or y
X

I ncl u di n g ca ncer hist or y, disease sta gi n g ( A n n 
Ar b or), ris k assess me nt (I PI sc ore), pri or ca ncer 
treat me nts, a n d i ncl usi o n/e xcl usi o n criteria.
De m o gra p hics/ me dical 
hist or y
X

See Secti o n 8. 1. 1 .
P h ysical e xa mi nati o n  
X  
X
X  
X  
X  
X  
X  
X

A c o m plete P E will be c o n d ucte d at Scree ni n g 
Visit o nl y; tar gete d/s y m pt o m -directe d P Es will 
be c o n d ucte d at ot her visits.

See Secti o n 8. 3. 1 f or a d diti o nal i nf or mati o n.
B o d y wei g ht
X  
X
X
X

See Secti o n 8. 3. 1 f or a d diti o nal i nf or mati o n.

Als o see Secti o n 6. 1. 1 f or d ose calc ulati o n wit h 
wei g ht.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 5
T a ble 1 .
St u d y Sc he d ule of Assess me nt
Visit I de ntifier
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 6
O n -Tre at me nt Peri o d ( 2 8 -d a y C ycle)
N otes
Scree n
C ycle 1
C ycle 2 - 3
≥C ycle 4
E O T
F U visits
L T F U

All scree ni n g s h o ul d be d o ne ≤2 8 da ys bef ore t he 
first d ose, u nless n ote d ot her wise.
C ycle D a y
≤2 8 d
D 1
D 4
D 8
D 1 5
D 2 2
D 1
D 8
D 1 5
D 2 2
D 1
D 1 5
7 d
2 8 d
9 0 d
Q 1 2 W

Da y relati ve t o start of st u d y i nter ve nti o n 
( Da y 1).
Visit Wi n d o w
( ± 1 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ±2 d p ost -l ast 
T X )
( 2 8- 3 5 d p ost-
l ast T X)
( + 7 p ost-l ast 
T X )
( ± 1 4 d p ost 
9 0 d F U)

After 1 year of st u d y i nter ve nti o n, c ycle visit date 
wi n d o ws are ± 7 d.
Vital si g ns
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X

O n da ys of i nf usi o n: as per l ocal g ui deli nes f or 
m o n ocl o nal a nti b o dies, wit h a mi ni m u m as 
f oll o ws f or eac h i nf usi o n of P F- 0 7 9 0 1 8 0 1 a n d 
tafasita ma b.
o
P F -0 7 9 0 1 8 0 1: C 1 D 1: pre ( wit hi n 1 5 mi n 
pri or), E OI ( ± 1 5 mi n), (e n d of): 2 h 
( ± 1 5 mi n). ≥C 1 D 8: pre a n d E OI ( ± 1 5 mi n).
o
Tafasita ma b: pre, 1 5 ( ± 5), 3 0 ( ± 1 0), a n d 
t he n e ver y 6 0 ( ± 1 5) mi n utes d uri n g i nf usi o n 
a n d at E OI ( ± 2 0 mi n). After 3 i nf usi o ns: pre 
a n d E OI ( ± 1 5 mi n).

See Secti o n 8. 3. 2 f or a d diti o nal i nf or mati o n. 
1 2 -Lea d E C G
X  
X
X
X  
X  
X

C 1 D 1, C 2 D 1, C 3 D 1: Pr e -P F - 0 7 9 0 1 8 0 1 d ose,
P F -0 7 9 0 1 8 0 1 E OI ( wi n d o w f or E OI: + 3 0 mi n).

C 4 D 1, C 5 D 1, C 6 D 1: pre P F - 0 7 9 0 1 8 0 1 d ose

See Secti o n 8. 3. 3 f or a d diti o nal i nf or mati o n.
B- s y m pt o ms
X  
X
X
X  
X

See Secti o n 8. 3. 6 .
E C O G assess me nt
X

Per A p pe n di x 1 3 .
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 6
T a ble 1 .
St u d y Sc he d ule of Assess me nt
Visit I de ntifier
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 6
O n -Tre at me nt Peri o d ( 2 8 -d a y C ycle)
N otes
Scree n
C ycle 1
C ycle 2 - 3
≥C ycle 4
E O T
F U visits
L T F U

All scree ni n g s h o ul d be d o ne ≤2 8 da ys bef ore t he 
first d ose, u nless n ote d ot her wise.
C ycle D a y
≤2 8 d
D 1
D 4
D 8
D 1 5
D 2 2
D 1
D 8
D 1 5
D 2 2
D 1
D 1 5
7 d
2 8 d
9 0 d
Q 1 2 W

Da y relati ve t o start of st u d y i nter ve nti o n 
( Da y 1).
Visit Wi n d o w
( ± 1 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ±2 d p ost -l ast 
T X )
( 2 8- 3 5 d p ost-
l ast T X)
( + 7 p ost-l ast 
T X )
( ± 1 4 d p ost 
9 0 d F U)

After 1 year of st u d y i nter ve nti o n, c ycle visit date 
wi n d o ws are ± 7 d.
Diar y car d (le nali d o mi de)  
X  
X
X
X  
X

See Secti o n 6. 5 .

T o be c ollecte d t hr o u g h C ycle 1 2 or E O T, 
w hic he ver occ urs first.
A Es/ S A Es
C o nti n u o usl y acti ve c ollecti o n

See Secti o n 8. 4 f or a d diti o nal i nf or mati o n.
Me dicati o ns
C o nc o mita nt me dicati o ns
S u bse q ue nt 
a ntica ncer 
t hera p y(ies)

C o nc o mita nt me dicati o ns t o be c ollecte d 
c o nti n u o usl y fr o m t he ti me of I C D t hr o u g h E O T.
C D 1 9 e x pressi o n (if p ost 
C A R -T)
X

C D 1 9 e x pressi o n t o be meas ure d i n partici pa nts 
wit h pri or C A R - T treat me nt: l ocal la b test (if 
a vaila ble) a n d tiss ue f or f ut ure ce ntral testi n g 
( b ot h m ust be a sa m ple after C A R-T a n d pri or t o 
C 1 D 1).

See als o Secti o n 8. 7. 8 .
S ur vi val stat us
X  
X

Ma y be c o n d ucte d b y p h o ne. 
L oc al L a b or at or y Assess me nts

See Secti o n 8. 3. 4 f or a d diti o nal i nf or mati o n.

See A p pe n di x 2 f or a list of cli nical la b orat or y 
tests t o be d o ne.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 7
T a ble 1 .
St u d y Sc he d ule of Assess me nt
Visit I de ntifier
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 6
O n -Tre at me nt Peri o d ( 2 8 -d a y C ycle)
N otes
Scree n
C ycle 1
C ycle 2 - 3
≥C ycle 4
E O T
F U visits
L T F U

All scree ni n g s h o ul d be d o ne ≤2 8 da ys bef ore t he 
first d ose, u nless n ote d ot her wise.
C ycle D a y
≤2 8 d
D 1
D 4
D 8
D 1 5
D 2 2
D 1
D 8
D 1 5
D 2 2
D 1
D 1 5
7 d
2 8 d
9 0 d
Q 1 2 W

Da y relati ve t o start of st u d y i nter ve nti o n 
( Da y 1).
Visit Wi n d o w
( ± 1 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ±2 d p ost -l ast 
T X )
( 2 8- 3 5 d p ost-
l ast T X)
( + 7 p ost-l ast 
T X )
( ± 1 4 d p ost 
9 0 d F U)

After 1 year of st u d y i nter ve nti o n, c ycle visit date 
wi n d o ws are ± 7 d.
HI V stat us
X

F or partici pa nts wit h k n o w n hist or y of HI V: C D 4 
c o u nt a n d viral l oa d
He patitis B/ C pa nel
X

M o nit or partici pa nts f or H B V reacti vati o n 
t hr o u g h o ut t he st u d y, if a p plica ble.

See A p pe n di x 2 , A p pe n di x 1 0 , a n d R E V LI MI D 
S m P C.
Pre g na nc y test ( W O C B P 
o nl y)
X  
X  
X  
X  
X  
X
X *
X
X *
X

Pre g na nc y test will be d o ne wee kl y at C 1; a n d 
m o nt hl y at C 2 a n d be y o n d. 
*: W O C B P partici pa nts wit h irre g ular c ycles 
s h o ul d ha ve t he test d o ne e ver y 2 wee ks.

See Secti o n 8. 3. 5 f or a d diti o nal i nf or mati on.
C o ntrace pti o n c hec k  
X  
X
X
X
X  
X

O nl y re q uire d f or W O C B P a n d me n wit h 
W O C B P part ner.

See Secti o n 4. 2. 3 a n d A p pe n di x 4 f or a d diti o nal 
i nf or mati o n.
F S H
X

F or c o nfir mati o n of p ost me n o pa usal stat us.
He mat ol o g y
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X

Ma y be c ollecte d u p t o 7 2 h o urs pri or t o d osi n g 
visit date.

See A p pe n di x 2 .
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 8
T a ble 1 .
St u d y Sc he d ule of Assess me nt
Visit I de ntifier
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 6
O n -Tre at me nt Peri o d ( 2 8 -d a y C ycle)
N otes
Scree n
C ycle 1
C ycle 2 - 3
≥C ycle 4
E O T
F U visits
L T F U

All scree ni n g s h o ul d be d o ne ≤2 8 da ys bef ore t he 
first d ose, u nless n ote d ot her wise.
C ycle D a y
≤2 8 d
D 1
D 4
D 8
D 1 5
D 2 2
D 1
D 8
D 1 5
D 2 2
D 1
D 1 5
7 d
2 8 d
9 0 d
Q 1 2 W

Da y relati ve t o start of st u d y i nter ve nti o n 
( Da y 1).
Visit Wi n d o w
( ± 1 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ±2 d p ost -l ast 
T X )
( 2 8- 3 5 d p ost-
l ast T X)
( + 7 p ost-l ast 
T X )
( ± 1 4 d p ost 
9 0 d F U)

After 1 year of st u d y i nter ve nti o n, c ycle visit date 
wi n d o ws are ± 7 d.
Ser u m c he mistries
X  
X
X  
X  
X  
X  
X  
X

Ma y be c ollecte d u p t o 7 2 h o urs pri or t o d osi n g 
visit date.

See A p pe n di x 2 .
C oa g ulati o n pa nel
X  
X
X
X

Ma y be c ollecte d u p t o 7 2 h o urs pri or t o d osi n g 
visit date.

See A p pe n di x 2 .
Uri nal ysis ( di pstic k)
X

Ma y be c ollecte d u p t o 7 2 h o urs pri or t o d osi n g 
visit date.

See A p pe n di x 2 .
Ser u m I m m u n o gl o b uli n 
c o nce ntrati o ns
X  
X
X
X  
X

Ma y be c ollecte d u p t o 7 2 h o urs pri or t o d osi n g 
visit date.

See A p pe n di x 2 .
St u d y I nter ve nti o n a n d Ot her Tre at me nts
Pre me dicati o ns
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X

See Secti o n 6. 1. 1 f or a d diti o nal i nf or mati o n.
P F - 0 7 9 0 1 8 0 1 I V i nf usi o n  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X

See Secti o n 6. 1. 1. 1 f or a d diti o nal i nf or mati o n.
Tafasita ma b I V i nf usi o n
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X

See Secti o n 6. 1. 1. 2 f or a d diti o nal i nf or mati o n.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 9
T a ble 1 .
St u d y Sc he d ule of Assess me nt
Visit I de ntifier
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 6
O n -Tre at me nt Peri o d ( 2 8 -d a y C ycle)
N otes
Scree n
C ycle 1
C ycle 2 - 3
≥C ycle 4
E O T
F U visits
L T F U

All scree ni n g s h o ul d be d o ne ≤2 8 da ys bef ore t he 
first d ose, u nless n ote d ot her wise.
C ycle D a y
≤2 8 d
D 1
D 4
D 8
D 1 5
D 2 2
D 1
D 8
D 1 5
D 2 2
D 1
D 1 5
7 d
2 8 d
9 0 d
Q 1 2 W

Da y relati ve t o start of st u d y i nter ve nti o n 
( Da y 1).
Visit Wi n d o w
( ± 1 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ±2 d p ost -l ast 
T X )
( 2 8- 3 5 d p ost-
l ast T X)
( + 7 p ost-l ast 
T X )
( ± 1 4 d p ost 
9 0 d F U)

After 1 year of st u d y i nter ve nti o n, c ycle visit date 
wi n d o ws are ± 7 d.
Le nali d o mi de
A d mi nister P O o n 
D 1 -D 2 1
A d mi nister P O 
o n D 1 -D 2 1
A d mi niste
r P O o n 
D 1 -D 2 1 
t hr o u g h 
C 1 2

See Secti o n 6. 1. 1. 3 f or a d diti o nal i nf or mati o n.
Dise ase Assess me nt ( L u ga n o Criteria 2 0 1 4: A p pe n di x 1 2 )
I ma gi n g: P E T/ C T or 
P E T/ M RI
X
C 3
D 1
C 6 D 1, 
C 9 D 1, 
C 1 2 D 1, 
C 1 8 D 1, 
C 2 4 D 1 
t he n 
yearl y 
u ntil P D.
X
( X) 
Sca ns ma y be re peate d at a n y ti me if pr o gressi ve 
disease is s us pecte d, t o c o nfir m t he occ urre nce of 
a C R or t o ma ke i m p orta nt treat me nt relate d 
decisi o ns. 

Wi n d o w f or i ma gi n g d uri n g st u d y is ± 7
d a y s.

See Secti o n 8. 2 f or a d diti o nal i nf or mati o n.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 0
T a ble 1 .
St u d y Sc he d ule of Assess me nt
Visit I de ntifier
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 6
O n -Tre at me nt Peri o d ( 2 8 -d a y C ycle)
N otes
Scree n
C ycle 1
C ycle 2 - 3
≥C ycle 4
E O T
F U visits
L T F U

All scree ni n g s h o ul d be d o ne ≤2 8 da ys bef ore t he 
first d ose, u nless n ote d ot her wise.
C ycle D a y
≤2 8 d
D 1
D 4
D 8
D 1 5
D 2 2
D 1
D 8
D 1 5
D 2 2
D 1
D 1 5
7 d
2 8 d
9 0 d
Q 1 2 W

Da y relati ve t o start of st u d y i nter ve nti o n 
( Da y 1).
Visit Wi n d o w
( ± 1 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ±2 d p ost -l ast 
T X )
( 2 8- 3 5 d p ost-
l ast T X)
( + 7 p ost-l ast 
T X )
( ± 1 4 d p ost 
9 0 d F U)

After 1 year of st u d y i nter ve nti o n, c ycle visit date 
wi n d o ws are ± 7 d.
Dia g n ostic q ualit y C T sca n
X
C 3
D 1
C 6 D 1, 
C 9 D 1, 
C 1 2 D 1, 
C 1 8 D 1, 
C 2 4 D 1 
t he n 
yearl y 
u ntil P D.
X
( X) 
Sca ns ma y be re peate d at a n y ti me if pr o gressi ve 
disease is s us pecte d, t o c o nfir m t he occ urre nce of 
a C R or t o ma ke i m p orta nt treat me nt relate d 
decisi o ns. 

Wi n d o w f or i ma gi n g
d uri n g st u d y is ± 7 d a y s.

See Secti o n 8. 2 f or a d diti o nal i nf or mati o n.
Brai n C T/ M RI if C N S 
i n v ol ve me nt is s us pecte d
X

C N S i n v ol ve me nt is a n e xcl usi o n criteri o n.
Ce ntr al L a b or at or y Assess me nts
P K a n d I m m u n o ge nicit y Assess me nts

Pr e -d ose P K sa m ples f or P F -0 7 9 0 1 8 0 1, 
tafasita ma b a n d le nali d o mi de are t o be c ollecte d 
bef ore a n y pre me dicati o n or st u d y i nter ve nti o n 
o n i n dicate d visits. 

See Secti o n 8. 5 a n d Secti o n 8. 8 f or a d diti o nal 
i nf or mati o n.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 1
T a ble 1 .
St u d y Sc he d ule of Assess me nt
Visit I de ntifier
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 6
O n -Tre at me nt Peri o d ( 2 8 -d a y C ycle)
N otes
Scree n
C ycle 1
C ycle 2 - 3
≥C ycle 4
E O T
F U visits
L T F U

All scree ni n g s h o ul d be d o ne ≤2 8 da ys bef ore t he 
first d ose, u nless n ote d ot her wise.
C ycle D a y
≤2 8 d
D 1
D 4
D 8
D 1 5
D 2 2
D 1
D 8
D 1 5
D 2 2
D 1
D 1 5
7 d
2 8 d
9 0 d
Q 1 2 W

Da y relati ve t o start of st u d y i nter ve nti o n 
( Da y 1).
Visit Wi n d o w
( ± 1 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ±2 d p ost -l ast 
T X )
( 2 8- 3 5 d p ost-
l ast T X)
( + 7 p ost-l ast 
T X )
( ± 1 4 d p ost 
9 0 d F U)

After 1 year of st u d y i nter ve nti o n, c ycle visit date 
wi n d o ws are ± 7 d.
Bl o o d f or P F -0 7 9 0 1 8 0 1 P K
X  
X
X
X  
X

C 1 D 1 a n d C 2 D 1: pre - d ose, E OI (a p pr o x. 6 0 mi n 
fr o m start of i nf usi o n, wit hi n 5 mi n of 
P F 0 7 9 0 1 8 0 1 i nf usi o n e n ds), 5 h ( ± 2 h) p ost-d ose 
(relati ve t o t he start of i nf usi o n).

C 1 D 8, C 3 D 1, C 4 D 1 a n d C 5 D 1: pre -d ose.

Starti n g C 7 u p t o C 1 3, c ollect pre -d ose o nl y 
e ver y 3 r d c ycle (ie, C 7 D 1, C 1 0 D 1, C 1 3 D 1) a n d 
t he n e ver y 6t h c ycle t hereafter ( C 1 9 D 1, C 2 5 D 1, 
etc.).
Bl o o d f or tafasita ma bP K
X
X
X  
X

C 1 D 1, C 2 D 1, C 3 D 1, a n d C 4 D 1: pre -d ose.

Starti n g C 7 u p t o C 1 3, c ollect pre -d ose o nl y 
e ver y 3r d c ycle (ie, C 7 D 1, C 1 0 D 1, C 1 3 D 1) a n d 
t he n e ver y 6t h c ycle t hereafter ( C 1 9 D 1, C 2 5 D 1, 
etc.).
Bl o o d f or le nali d o mi de P K
X
X
C 4 
o nl y

C 1 D 1, C 2 D 1, C 3 D 1, C 4 D 1: pre -d ose.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 2
T a ble 1 .
St u d y Sc he d ule of Assess me nt
Visit I de ntifier
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 6
O n -Tre at me nt Peri o d ( 2 8 -d a y C ycle)
N otes
Scree n
C ycle 1
C ycle 2 - 3
≥C ycle 4
E O T
F U visits
L T F U

All scree ni n g s h o ul d be d o ne ≤2 8 da ys bef ore t he 
first d ose, u nless n ote d ot her wise.
C ycle D a y
≤2 8 d
D 1
D 4
D 8
D 1 5
D 2 2
D 1
D 8
D 1 5
D 2 2
D 1
D 1 5
7 d
2 8 d
9 0 d
Q 1 2 W

Da y relati ve t o start of st u d y i nter ve nti o n 
( Da y 1).
Visit Wi n d o w
( ± 1 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ±2 d p ost -l ast 
T X )
( 2 8- 3 5 d p ost-
l ast T X)
( + 7 p ost-l ast 
T X )
( ± 1 4 d p ost 
9 0 d F U)

After 1 year of st u d y i nter ve nti o n, c ycle visit date 
wi n d o ws are ± 7 d.
A D A/ N A b f or P F - 0 7 9 0 1 8 0 1 
( P B)
X
X
X  
X
See N otes

C 1 D 1, C 2 D 1, C 3 D 1, C 4 D 1 a n d C 5 D 1: pre -d ose.

Starti n g C 7 u p t o C 1 3, c ollect pre -d ose o nl y 
e ver y 3 r d c ycle (ie, C 7 D 1, C 1 0 D 1, C 1 3 D 1) a n d 
t he n e ver y 6t h c ycle t hereafter ( C 1 9 D 1, C 2 5 D 1, 
etc.). 

F U visits a n d L T F U: Partici pa nts wit h a n 
u nres ol ve d A E at t he e n d of st u d y treat me nt 
c o nsi dere d p ossi bl y relate d t o A D A f or mati o n 
ma y be as ke d t o ret ur n t o t he cli nic f or A D A 
bl o o d sa m pli n g at a p pr o xi matel y 3- m o nt h 
i nter vals (if feasi ble gi ve n t he u n derl yi n g 
disease) u ntil t he A E or its se q uelae res ol ve or 
sta bilize at a le vel acce pta ble t o t he i n vesti gat or 
a n d s p o ns or u p t o a ma xi m u m of 9 m o nt hs fr o m 
t he last st u d y treat me nt.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 3
T a ble 1 .
St u d y Sc he d ule of Assess me nt
Visit I de ntifier
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 6
O n -Tre at me nt Peri o d ( 2 8 -d a y C ycle)
N otes
Scree n
C ycle 1
C ycle 2 - 3
≥C ycle 4
E O T
F U visits
L T F U

All scree ni n g s h o ul d be d o ne ≤2 8 da ys bef ore t he 
first d ose, u nless n ote d ot her wise.
C ycle D a y
≤2 8 d
D 1
D 4
D 8
D 1 5
D 2 2
D 1
D 8
D 1 5
D 2 2
D 1
D 1 5
7 d
2 8 d
9 0 d
Q 1 2 W

Da y relati ve t o start of st u d y i nter ve nti o n 
( Da y 1).
Visit Wi n d o w
( ± 1 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ±2 d p ost -l ast 
T X )
( 2 8- 3 5 d p ost-
l ast T X)
( + 7 p ost-l ast 
T X )
( ± 1 4 d p ost 
9 0 d F U)

After 1 year of st u d y i nter ve nti o n, c ycle visit date 
wi n d o ws are ± 7 d.
A D A/ N A b f or tafasita ma b 
( P B)
X
X
X  
X
See N otes

C 1 D 1, C 2 D 1, C 3 D 1, C 4 D 1: pre -d ose.

Starti n g C 7 u p t o C 1 3, c ollect pre -d ose o nl y 
e ver y 3 r d c ycle (ie, C 7 D 1, C 1 0 D 1, C 1 3 D 1) a n d 
t he n e ver y 6t h c ycle t hereafter ( C 1 9 D 1, C 2 5 D 1, 
etc.).

F U visits a n d L T F U: Partici pa nts wit h a n 
u nres ol ve d A E at t he e n d of st u d y treat me nt 
c o nsi dere d p ossi bl y relate d t o A D A f or mati o n 
ma y be as ke d t o ret ur n t o t he cli nic f or A D A 
bl o o d sa m pli n g at a p pr o xi matel y 3- m o nt h 
i nter vals (if feasi ble gi ve n t he u n derl yi n g 
disease) u ntil t he A E or its se q uelae res ol ve or 
sta bilize at a le vel acce pta ble t o t he i n vesti gat or 
a n d s p o ns or u p t o a ma xi m u m of 9 m o nt hs fr o m 
t he last st u d y treat me nt.
Ge netics a n d Bi o m ar ker Assess me nts

Pr e -d ose sa m ples are t o be c ollecte d bef ore a n y 
pre - me dicati o n or st u d y treat me nt a d mi nistrati o n 
o n i n dicate d visits.

See Secti o n 8. 6 a n d Secti o n 8. 7 f or a d diti o nal 
i nf or mati o n.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 4
T a ble 1 .
St u d y Sc he d ule of Assess me nt
Visit I de ntifier
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 6
O n -Tre at me nt Peri o d ( 2 8 -d a y C ycle)
N otes
Scree n
C ycle 1
C ycle 2 - 3
≥C ycle 4
E O T
F U visits
L T F U

All scree ni n g s h o ul d be d o ne ≤2 8 da ys bef ore t he 
first d ose, u nless n ote d ot her wise.
C ycle D a y
≤2 8 d
D 1
D 4
D 8
D 1 5
D 2 2
D 1
D 8
D 1 5
D 2 2
D 1
D 1 5
7 d
2 8 d
9 0 d
Q 1 2 W

Da y relati ve t o start of st u d y i nter ve nti o n 
( Da y 1).
Visit Wi n d o w
( ± 1 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ±2 d p ost -l ast 
T X )
( 2 8- 3 5 d p ost-
l ast T X)
( + 7 p ost-l ast 
T X )
( ± 1 4 d p ost 
9 0 d F U)

After 1 year of st u d y i nter ve nti o n, c ycle visit date 
wi n d o ws are ± 7 d.
T u m o r Tiss ue
X  
At rela pse/ P D/ E O T (str o n gl y rec o m me n de d), a n d as cli nicall y i n dicate d.

See Secti o n 8. 7. 8 f or a d diti o nal i nf or mati o n.
Bl o o d sa m ple f or circ ulati n g 
bi o mar ker a nal ysis
X  
X  
X
C 2 
o nl y
C 2 
o nl y

C ollect w h ole bl o o d f or pr ocessi n g i nt o ser u m as 
i n dicate d:
o
C 1 D 1 a n d C 2 D 1: pre -d ose; P F - 0 7 9 0 1 8 0 1 
E OI ( wit hi n 5 mi n fr o m t he e n d of 
P F - 0 7 9 0 1 8 0 1 i nf usi o n); 5 h (± 2 h wi n d o w) 
p ost d ose of P F -0 7 9 0 1 8 0 1 ( 5 h relati ve t o t he 
start of P F-0 7 9 0 1 8 0 1 i nf usi o n, prefera bl y 
n ot c ollecte d d uri n g tafasita ma b i nf usi o n).
o
C 1 D 4, C 1 D 8, C 2 D 8: pre -d os e. 
Bl o o d sa m ple f or C D 4 7 
rece pt or occ u pa nc y
X  
X
X
C 4, 
C 5 
o nl y

C ollect w h ole bl o o d as i n dicate d:
o
C 1 D 1, C 2 D 1: pre -d ose a n d E OI [e n d of 
P F -0 7 9 0 1 8 0 1 i nf usi o n ( + 5 mi n wi n d o w)]. 
o
C 1 D 8, C 3 D 1, C 4 D 1, C 5 D 1: pre -d ose. 

Will be c ollecte d o nl y i n t he U nite d States a n d its 
territ ories.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 5
T a ble 1 .
St u d y Sc he d ule of Assess me nt
Visit I de ntifier
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 6
O n -Tre at me nt Peri o d ( 2 8 -d a y C ycle)
N otes
Scree n
C ycle 1
C ycle 2 - 3
≥C ycle 4
E O T
F U visits
L T F U

All scree ni n g s h o ul d be d o ne ≤2 8 da ys bef ore t he 
first d ose, u nless n ote d ot her wise.
C ycle D a y
≤2 8 d
D 1
D 4
D 8
D 1 5
D 2 2
D 1
D 8
D 1 5
D 2 2
D 1
D 1 5
7 d
2 8 d
9 0 d
Q 1 2 W

Da y relati ve t o start of st u d y i nter ve nti o n 
( Da y 1).
Visit Wi n d o w
( ± 1 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ±2 d p ost -l ast 
T X )
( 2 8- 3 5 d p ost-
l ast T X)
( + 7 p ost-l ast 
T X )
( ± 1 4 d p ost 
9 0 d F U)

After 1 year of st u d y i nter ve nti o n, c ycle visit date 
wi n d o ws are ± 7 d.
Bl o o d sa m ple f or  
 
X
X  
X
X

C ollect w h ole bl o o d as i n dicate d:
o
C 1 D 1, C 1 D 1 5, C 2 D 1, C 3 D 1: pre -d ose.
o
E O T: sa m pli n g is n ot re q uire d f or 
partici pa nts w h o are acti ve o n treat me nt f or 
> 1 year.
Bl o o d sa m ple f or  
 
X  
X  
X  
X
C 5 
o nl y
X

C ollect w h ole bl o o d as i n dicate d:
o
C 1 D 1, C 1 D 8, C 1 D 1 5, C 2 D 1, C 3 D 1 a n d 
C 5 D 1: pre -d ose.
o
E O T: sa m pli n g is n ot re q uire d f or 
partici pa nts w h o are acti ve o n treat me nt f or 
> 1 year.
Bl o o d sa m ple f or s pecifie d 
ge netic researc h
X

C ollect w h ole bl o o d pre -d ose.
sa m ple f or matc he d 
c o ntr ol a n d s pecifie d ge netic 
researc h
X

C ollect 
pre -d ose.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)
C CI
C CI
C CI
C CI

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 6
T a ble 1 .
St u d y Sc he d ule of Assess me nt
Visit I de ntifier
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 6
O n -Tre at me nt Peri o d ( 2 8 -d a y C ycle)
N otes
Scree n
C ycle 1
C ycle 2 - 3
≥C ycle 4
E O T
F U visits
L T F U

All scree ni n g s h o ul d be d o ne ≤2 8 da ys bef ore t he 
first d ose, u nless n ote d ot her wise.
C ycle D a y
≤2 8 d
D 1
D 4
D 8
D 1 5
D 2 2
D 1
D 8
D 1 5
D 2 2
D 1
D 1 5
7 d
2 8 d
9 0 d
Q 1 2 W

Da y relati ve t o start of st u d y i nter ve nti o n 
( Da y 1).
Visit Wi n d o w
( ± 1 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ± 2 d)
( ±2 d p ost -l ast 
T X )
( 2 8- 3 5 d p ost-
l ast T X)
( + 7 p ost-l ast 
T X )
( ± 1 4 d p ost 
9 0 d F U)

After 1 year of st u d y i nter ve nti o n, c ycle visit date 
wi n d o ws are ± 7 d.
Bl o o d sa m ple f or  
 
X
X
C 6 D 1, at 
C R a n d at 
ti me of 
rela pse/ P
D
X

C ollect w h ole bl o o d as i n dicate d f or pr ocessi n g 
i nt o plas ma:
o
C 1 D 1, C 2 D 1, C 3 D 1, C 6 D 1 : pre-d ose.
o
At C R a n d at ti me of rela pse/ P D: pre- d ose.
o
E O T: sa m pli n g is n ot re q uire d f or 
partici pa nts w h o are acti ve o n treat me nt f or 
> 1 year.
Retai ne d researc h sa m ple f or 
ge netics ( Pre p D 1)
X

C ollect w h ole bl o o d pre -d ose.

If n ot c ollecte d o n t he desi g nate d c ollecti o n da y, 
c ollect at t he ne xt a vaila ble ti me p oi nt w he n 
bi os peci me ns are bei n g c ollecte d i n c o nj u ncti o n 
wit h a partici pa nt visit.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)
C CI

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 7
2. I N T R O D U C TI O N
D L B C L is t he m ost c o m m o n t y pe of l y m p h o ma e nc o m passi n g ar o u n d 3 0 % t o 4 0 % of t he 
ne wl y  dia g n ose d cases of N H L.1 R- C H O P has bee n t he sta n dar d treat me nt f or ne wl y 
dia g n ose d patie nts f or o ver 2 deca des c uri n g a p pr o xi matel y  6 0 % of t he patie nts.1 I n ol der 
patie nts mi ni R -C H O P (a re d uce d i nte nsit y re gi me n f or patie nts o ver 8 0 ye ars ol d) m a y  be 
use d as first li ne treat me nt. 2
Patie nts refract or y  t o or rela psi n g after first li ne treat me nt ma y pr ocee d t o i n d ucti o n 
c he m ot hera p y t reat ment (e g, R -I C E or R-D H A P) f oll o we d b y  A S C T. Patie nts n ot eli gi ble t o 
tra ns pla nt d ue t o a ge or c o-m or bi dities ma y  pr ocee d t o less i n vasi ve treat me nts li ke 
R- Ge m O x ( rit u xi ma b, ge mcita bi ne a n d o xali plati n).
P olat uz u ma b ve d oti n, a n a nti b o d y  dr u g c o nj u gate tar geti n g C D 7 9 b o n t he B cells s urface, i n 
c o m bi nati o n wit h be n da m usti ne a n d rit u xi ma b recei ve d accelerate d/c o n diti o nal a p pr o val i n 
R/ R D L B C L after at least 2 pri or li nes of t hera pies. 3 Re p orte d res p o nse i n t he p ola + B R ar m 
was 4 5 % ( C R R 4 0 %); 4 a n d u p date d data s h o we d me dia n P F S was 9. 2 ( 9 5 % CI , 6. 0-1 3. 0) 
m o nt hs a n d me dia n O S was 1 2. 4 ( 9 5 % CI, 9. 0 -3 2. 0) m o nt hs. 3 A c o nfir mat or y P hase 3 trial 
r u n i n u ntreate d D L B C L patie nts wit h i nter me diate or hi g h -ris k disease c o m pare d t he P F S of 
R- C H O P vers us a m o difie d R - C H O P re gi me n w here p olat uz u ma b ve d oti n was a d mi nistere d 
i nstea d of vi ncristi ne ( p ola- R-C H P), a n d after a me dia n f oll o w u p of 2 8. 2 m o nt hs, 
p ola - R-C H P was s u peri or w he n c o m pare d t o R -C H O P i n ter ms of P F S ( 7 6. 7 % [ 9 5 % CI , 
7 2. 7 %- 8 0. 8 %] vs 7 0. 2 % [ 9 5 % CI , 6 5. 8 %-7 4. 6 %]). 5
I n 2 0 2 0 tafasita ma b i n c o m bi nati o n wit h le nali d o mi de recei ve d accelerate d/c o n diti o nal 
a p pr o vals f or patie nts wit h R/ R D LB C L w h o are n ot ca n di da tes f or A S C T. Efficac y of 
tafasita ma b wit h le nali d o mi de was e val uate d i n a si n gle ar m P hase 2 st u d y ( L-MI N D) i n 
patie nts wit h rela pse d refract or y  D L B C L n ot eli gi ble f or hi g h d ose c he m ot hera p y or A S C T.6
Pri mar y  refract or y patie nts ( defi ne d as rela pse wit hi n 6 m o nt hs of first-li ne treat me nt) were 
e xcl u de d. Pri or t hera pies ha d t o i ncl u de a C D 2 0 -directe d t hera p y . T he O R R re p orte d i n 
8 0 patie nts was 6 0 % ( 9 5 % CI , 4 8 %-7 1 %) wit h a C R R of 4 3 % ( 9 5 % CI , 3 2 %-5 4 %) a n d a 
me dia n P F S of 1 2. 1 ( 9 5 % CI, 5. 7-n ot reac he d) m o nt hs. T he m ost c o m m o n ( > 1 0 %) ≥G 3 A Es 
i ncl u de ne utr o pe nia ( 4 8 %), t hr o m b oc yt o pe nia ( 1 7 %), a n d fe brile ne utr o pe nia ( 1 2 %). 
Le nali d o mi de as a si n gle a ge nt has m o dest acti vit y i n patie nts wit h D L B C L ; t he c o m bi nati o n 
of tafasita ma b a n d le nali d o mi de, h o we ver, s h o we d i ncrease d A D C C acti vit y  i n D L B C L cells 
c o m pare d t o tafasita ma b or le nali d o mi de al o ne a n d le d t o better cli nical o utc o me c o m pare d 
t o real-w orl d data of le nali d o mi de as a si n gle a ge nt.7
C A R -T cell t hera pies (e g, a xica bta ge ne cil ole ucel, tisa ge nlecle ucel a n d lis oca bta ge ne 
marale uce ) are ne w treat me nt o pti o ns f or patie nts wit h R/ R D L B C L . A xica bta ge ne 
cil ole ucel, a n a ut ol o g o us a nti- C D 1 9 C A R -T cell t hera p y, was first e x pl ore d i n t he Z U M A - 1 
trial. In t his st u d y , e nr olli n g patie nts wit h R/ R D L B C L after fail ure of c o n ve nti o nal t hera p y, 
8 3 % of t he patie nts ha d a n O R, 5 8 % ac hie ve d a C R a n d t he m e dia n P F S was 5. 9 ( 9 5 % CI, 
3. 3 -1 5. 0) m o nt hs. 8 A xica bta ge ne cil ole ucel has bee n a p pr o ve d i n t he U S f or patie nts wit h 
R/ R D L B C L after at least 2 pri or li nes of s y ste mic t hera p y a n d m ore rece ntl y i n patie nts wit h 
D L B C L refract or y  t o first li ne c he m oi m m u n ot hera p y or wit h rela pse wit hi n 1 2 m o nt hs of 
first li ne c he m oi m m u n ot hera py. 9 C A R -T cell t hera p y  still prese nts c halle n ges f or patie nts’ 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 8
access, i ncl u di n g bei n g a vaila ble o nl y  at maj or aca de mic i nstit uti o ns, t ur n-ar o u n d ti me 
re q uire d f or le u ka p heresis, a n d prese nti n g wit h si g nifica nt t o xicities ( 4 8 % of t he patie nts 
re p orte d ≥G 3 A Es, i ncl u di n g 1 1 % c y t o ki ne release s yn dr o me a n d 3 2 % ne ur ol o gical e ve nts) 
w hic h are c urre ntl y  li miti n g t heir use.8 T heref ore, ne w treat me nts are ur ge ntl y  nee de d as t his 
c o nstit utes a n area of u n met me dical nee d wit h c urre ntl y li mite d a vaila ble treat me nt o pti o ns.
C D 4 7 is a n i n nate i m m u ne c hec k p oi nt t hat bi n ds SI R P α a n d deli vers a “ d o n’t eat me” si g nal 
t o s u p press macr o p ha ge p ha g oc yt osis. O vere x pressi o n of C D 4 7 i n s oli d a n d he mat ol o gical 
mali g na ncies, i ncl u di n g i n D L B C L, is ass ociate d wit h p o or pr o g n osis f or patie nts’ 
o utc o me. 1 0
P F -0 7 9 0 1 8 0 1 ( pre vi o usl y  referre d t o as T TI-6 2 2) is a f usi o n pr otei n c o nsisti n g of t he 
C D 4 7 -bi n di n g d o mai n of h u ma n SI R P α li n ke d t o t he Fc re gi o n of h u ma n I gG 4. I t is desi g ne d 
t o e n ha nce p ha g oc yt osis a n d a ntit u m or acti vit y b y pre ve nti n g C D 4 7 fr o m deli veri n g its 
i n hi bit or y si g nal as well as ge nerati n g a m o derate pr o-p ha g oc y tic si g nal via I g G 4 Fc. 
Precli nical st u dies de m o nstrate t hat P F- 0 7 9 0 1 8 0 1 i n d uces macr o p ha ge -me diate d 
p ha g oc y t osis of differe nt mali g na nt cell li nes, i ncl u di n g D L B C L cells, decreases t u m or 
gr o wt h a n d i m pr o ves s ur vi val i n a D L B C L xe n o graft t u m o r m o del.
B y  bl oc ki n g C D 4 7, it is e x pecte d t hat t he c o m bi nati o n of P F - 0 7 9 0 1 8 0 1 wit h a Fc R -acti vati n g 
a nti b o d y, li ke tafasita ma b, w o ul d pre ve nt a n i n hi bit or y si g nal a n d deli ver a p ositi ve sti m ul us 
t o macr o p ha ges, res ulti n g i n t he sy ner gistic p ha g oc yt osis a n d eli mi nati o n of tar get cells. 
I n dee d, it has bee n de m o nstrate d t hat t he c o m bi nati o n wit h tafasita ma b a n d a n 
a nti-C D 4 7 -bl oc ki n g a nti b o d y  p ote ntiate d t he a nti-t u m or acti vit y of tafasita ma b i n a 
pre -cli nical B ur kitt l ym p h o ma t u m or m o del. 1 1
I n a d diti o n t o t he p ote ntial s yner g y  i n A D C P, tafasita ma b ca n pr o vi de a nti-t u m or acti vities 
t hr o u g h i n d ucti o n of N K me diate d a nti b o d y-de pe n de nt c y t ot o xicit y, a n d direct t u m or 
c yt ot o xicit y via i n d ucti o n of a p o pt osis.1 2
O n t he ot her ha n d, le nali d o mi de, a sec o n d ge nerati o n i m m u n o m o d ulat or y  a ge nt, has bee n 
s h o w n t o ca use pr oliferati o n a n d acti vati o n of T a n d N K cells. 1 3 B y  acti vati n g N K cells, 
le nali d o mi de has s h o w n t o e n ha nce tafasita ma b me diate d A D C C acti vity. 1 4 I n a d diti o n, 
le nali d o mi de als o has t he p ote ntial t o i ncrease P F - 0 7 9 0 1 8 0 1-me diate d A D C P acti vit y  b y 
i n d ucti o n of “eat” si g nals t hr o u g h cell ular stress.
T heref ore, b y e n ga gi n g o verla p pi n g a n d differe nt mec ha nis ms, t he c o m bi nati o n of 
P F - 0 7 9 0 1 8 0 1, tafasita ma b a n d le nali d o mi de is e x pecte d t o res ult i n i ncrease d a nti-t u m or 
acti vit y i n patie nts wit h R/ R D LB C L.
I n t he o n g oi n g P hase 1 St u d y C 4 9 7 1 0 0 1 , hea vily pretreate d partici pa nts wit h R/ R l y m p h o ma 
i ncl u di n g R/ R D L B C L ha ve bee n treate d wit h differe nt d oses of si n gle a ge nt P F- 0 7 9 0 1 8 0 1. 
As of 1 2 A pril 2 0 2 1, P F- 0 7 9 0 1 8 0 1 has bee n a d mi nistere d t o 4 3 partici pa nts at d ose le vels of 
u p t o 1 8 m g/ k g Q W a n d has bee n well -t olerate d. Acti vit y has bee n s h o w n i n R/ R l ym p h o ma.
T heref ore, c o nsi deri n g t he differe nt a n d n o n -re d u n da nt, t h o u g h c o m ple me ntar y mec ha nis ms 
of acti o n of P F -0 7 9 0 1 8 0 1, ta fasita ma b, a n d le nali d o mi de a n d t he safet y pr ofile of 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 9
P F -0 7 9 0 1 8 0 1 fr o m S t u d y C 4 9 7 1 0 0 1 t his c o m bi nati o n ma y  offer a m ore efficaci o us a n d 
t olera ble treat me nt o pti o n f or ol der patie nts or patie nts wit h c o-m or bi dities t hat are n ot 
ca n di dates f or hi g h d ose c he m ot hera p y a n d/ or A S C T.
2. 1. St u d y R ati o n ale 
T he p ur p ose of t his P hase 1 b/ 2 st u d y  is t o e val uate t he safet y, t olera bilit y a n d p ote ntial 
cli nical be nefits of P F -0 7 9 0 1 8 0 1 i n c o m bi nati o n wit h sta n dar d d oses of tafasita ma b a n d 
le nali d o mi de i n partici pa nts wit h R/ R DL B C L n ot eli gi ble f or or n ot willi n g t o u n der g o hi g h 
d ose c he m ot hera p y f oll o we d b y A S C T. P hase 1 b will assess D L Ts t o select u p t o 2 fi xe d 
d oses of P F -0 7 9 0 1 8 0 1 t o be a d mi nistere d i n c o m bi nati o n wit h tafasita ma b a n d le nali d o mi de 
i n t he ra n d o mize d P hase 2 of t he st u d y. T he P hase 2 of t he st u d y will deter mi ne t he 
rec o m me n de d P hase 3 d ose of P F-0 7 9 0 1 8 0 1 t o be a d mi nistere d i n c o m bi nati o n wit h 
tafasita ma b a n d le nali d o mi de.
P hase 2 of t he st u d y will n ot be i nitiate d per b usi ness decisi o n ma de b y Pfizer (pr ot oc ol 
a me n d me nt 2) .
2. 2. B ac k gr o u n d 
2. 2. 1. Dr u g Mec h a nis m of Acti o n - P F -0 7 9 0 1 8 0 1
P F -0 7 9 0 1 8 0 1 is a n o vel f usi o n pr otei n c o nsisti n g of t he C D 4 7 -bi n di n g d o mai n of h u ma n 
SI R P α li n ke d t o t he Fc re gi o n of h u ma n I g G 4. It is desi g ne d t o e n ha nce p ha g oc y t osis a n d 
a ntit u m or acti vit y b y  pre ve nti n g C D 4 7 fr o m deli veri n g its i n hi bit or y si g nal as well as 
ge nerati n g a m o derate pr o -p ha g oc y tic si g nal via I g G 4 Fc (Fi g ure 1 ).
P F -0 7 9 0 1 8 0 1 h as re p orte d si n gle a ge nt acti vit y i n l ym p h oi d mali g na ncies a n d wit h C Rs i n 
he mat ol o gic mali g na ncies t hr o u g h C D 4 7/ SI R P α bl oc ki n g. T he c urre nt cli nical dataset 
i ncl u des m o n ot hera py res p o nses after I V a d mi nistrati o n i n differe nt t y pes of l y m p h o mas 
( D L B C L, F L, C T C L , P T C L) o ver a wi de d ose ra n ge, wit h a pr ol o n ge d D o R (i n res p o n ders, 
me dia n 1 0 6 [ 7 1 -8 8 0 +] da ys o n treat me nt).
Fi g ure 1.
P F -0 7 9 0 1 8 0 1 Str uct ure a n d Mec h a nis m of Acti o n
Hi g h le vels of C D 4 7 ha ve bee n f o u n d t o c orrelate wit h p o or cli nical pr o g n osis i n partici pa nts 
wit h a n u m ber of ca ncer t y pes, i ncl u di n g m ost he mat ol o gic mali g na ncies .1 5 ,1 6 ,1 7 ,1 8. Hi g h 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 0
C D 4 7 e x pressi o n c orrelates wit h m ore a g gressi ve disease a n d p o orer cli nical o utc o mes. 1 9 F or 
e xa m ple, o verall s ur vi val was si g nifica ntl y l o wer f or partici pa nts wit h D L B C L or ma ntle cell 
l ym p h o ma w h o ha d ele vate d C D 4 7 e x pressi o n. 1 6 T he se fi n di n gs are c o nsiste nt wit h t u m or 
cells e x pl oiti n g t he s u p pressi ve C D 4 7 -SI R P α a xis t o e va de macr o p ha ge -me diate d 
destr ucti o n. Bl oc ka de of C D 4 7 b y  P F-0 7 9 0 1 8 0 1 is e x pecte d t o e n ha nce t he a nti -t u m or 
acti vit y of tafasita ma b a n d le nali d o mi de i n D L B C L.
2. 2. 2. N o ncli nic al O ver vie w of P F -0 7 9 0 1 8 0 1
E xte nsi ve i n vitr o testi n g de m o nstrate d t hat P F -0 7 9 0 1 8 0 1 b o u n d t o h u ma n he mat o p oietic 
t u m or cell li nes a n d pri mar y t u m or sa m ples as well as n or mal h u ma n bl o o d cells, wit h t he 
e xce pti o n of h u ma n re d bl o o d cells. U nli ke a nti -C D 4 7 a nti b o dies (e g, ma gr oli ma b, 
pre vi o usl y  na me d 5 F 9), P F-0 7 9 0 1 8 0 1 bi n ds mi ni mall y  t o h u ma n R B C (Fi g ure 2 ). D ue t o t his 
pr o pert y, P F -0 7 9 0 1 8 0 1 is n ot e x pe cte d t o ca use a ne mia, or t o i nterfere wit h bl o o d tra nsf usi o n 
c o m pati bilit y testi n g.
Fi g ure 2.
P F -0 7 9 0 1 8 0 1 Bi n ds Mi ni m all y t o H u m a n Re d Bl o o d Cells
Precli nical st u dies ha ve de m o nstrate d t hat P F -0 7 9 0 1 8 0 1 was effecti ve i n pr o m oti n g 
macr o p ha ge -me diate d p ha g oc y t osis of vari o us B cell l ym p h o ma cell s i n vitr o. F urt her m ore, 
w he n i n vi v o efficac y  was assesse d i n a T ole d o D L B CL xe n o graft m o del, treat m e nt of 
P F -0 7 9 0 1 8 0 1 res ulte d i n a si g nifica nt re d ucti o n i n t u m or gr o wt h a n d i m pr o ve d o verall 
s ur vi val, c o m pare d t o a c o ntr ol Fc (Fi g ure 3 ).
R B Cs fr o m healt h y h u ma n d o n ors ( n = 4 3) w ere i nc u bate d wit h sat urati n g c o nce ntrati o ns of P F -0 7 9 0 1 8 0 1, 
a nti -C D 4 7 m o n ocl o nal a nti b o dies (cl o nes B RI C 1 2 6, 2 D 3, C C 2 C 6, B 6 H 1 2, 5 F 9) or c o ntr ols, w as he d, 
f oll o we d b y bi oti n ylate d a nti-h u ma n I g G or a nti -m o use I g G a n d stre pta vi di n -P E. Cells were w as he d, fi xe d, 
a n d a nal yze d b y fl o w c yt o metr y.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 1
Fi g ure 3.
I n Vitr o a n d I n Vi v o A nti-T u m or Acti vit y of P F -0 7 9 0 1 8 0 1
2. 2. 3. Cli nic al O ver vie w
P F -0 7 9 0 1 8 0 1 is bei n g e val uate d i n a n o n g oi n g P hase 1, t w o -part, m ulti -ce nter, 1a/ 1 b st u d y i n 
partici pa nt s wit h a d va nce d he mat ol o gic mali g na ncies, i ncl u di n g ly m p h o ma, le u ke mia, a n d 
M M ( Pr ot oc ol C 4 9 7 1 0 0 1 [ pre vi o usl y  referre d as T TI-6 2 2 -0 1]). I n t he P hase 1a 
d ose -escalati o n part of t he st u d y, partici pa nts wit h a d va nce d l y m p h o ma are e nr olle d i n 
se q ue ntial d ose c o h orts t o recei ve P F -0 7 9 0 1 8 0 1 m o n ot hera p y  Q W t o c haracterize safety, 
t olera bilit y, a n d P K of P F-0 7 9 0 1 8 0 1. I n t he P hase 1 b of t he st u d y, partici pa nts wit h D L B C L, 
M M a n d A M L  are treate d i n c o m bi nati o n wit h selecte d a p pr o ve d a nti- ca ncer a ge nts i n 
se veral c oh orts t o f urt her defi ne safet y a n d t o c haracterize efficac y.
2. 2. 3. 1. Cli nic al S afet y
As of 1 2 A pril 2 0 2 1, P F -0 7 9 0 1 8 0 1 ha d bee n a d mi nistere d i n St u d y  C 4 9 7 1 0 0 1 t o 
4 3 partici pa nts wit h R/ R l y m p h o ma i n ei g ht differe nt d ose -escalati o n, si n gle -t hera p y c o h orts, 
at d oses ra n gi n g fr o m 0. 0 5 m g/ k g t o 1 8. 0 m g/ k g Q W. A t otal of 3 7/ 4 3 ( 8 6 %) partici pa nts 
e x perie nce d T E A Es, a n d i n 2 0/ 4 3 ( 4 7 %) of w h o m t he T E A Es were assesse d as 
treat me nt-relate d by t he i n vesti gat or. T he m ost fre q ue nt ( ≥9 %) treat me nt -relate d T E A Es 
i ncl u de d t hr o m b oc yt o pe nia ( n = 9, 2 1 %), ne utr o pe nia ( n = 5, 1 2 %), a n d a ne mia a n d fati g ue 
( n = 4 eac h, 9 %).
T u m or V ol u m e ( m m 3 )
P ha g oc yt osis of D L B C L cell li nes was assesse d i n t he prese nce of P F -0 7 9 0 1 8 0 1 or c o ntr ol Fc i n vitr o (t o p). 
Acti vit y of P F -0 7 9 0 1 8 0 1 w as assesse d i n a D L B C L xe n o graft mo del ( b ott o m). Mice w ere d ose d 
i ntra perit o neall y 5 ti mes per wee k wit h P F-0 7 9 0 1 8 0 1 at 1 0 m g/ k g or c o ntr ol Fc ( 6. 6 7 m g/ k g) starti n g o n 
D a y 1 0 f or a t otal of 6 we e ks. Mea n t u m or v ol u mes ± sta n dar d err or of t he mea n were rec or de d o nl y f or 
ti me p oi nts at w hic h ≤2 5 % mice per gr o u p w ere sacrifice d ( b ott o m left pa nel). S ur vi val pl ot of t he 
t u m or-beari n g mice is s h o w n i n t he b ott o m ri g ht pa nel.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 2
M ost T E A Es ha ve bee n G 1 or G 2 a n d re versi ble. G 3- 4 T E A Es ( ne utr o pe nia a n d 
t hr o m b oc yt o pe nia [ 5 partici pa nts, 1 2 % eac h], a n d p ne u m o nia [ 2 partici pa nts, 5 %]) were 
re p orte d i n 16 ( 3 7 %) partici pa nts, a n d i n 6 ( 1 4 %) were assesse d as treat me nt- relate d by t he 
i n vesti gat or ( ne utr o pe nia [ 4 partici pa nts, 9 % ], t hr o m b oc yt o pe nia [ 2 partici pa nts, 5 %], a n d 
p ne u m o nia [ 1 partici pa nt, 2 %]). A si n gle D L T of re versi ble, as y m pt o matic G 4 
t hr o m b oc yt o pe nia has bee n o bser ve d i n a partici pa nt treate d i n t he 8 m g / k g Q W c o h ort; t he 
c o h ort was e x pa n de d a n d n o ot her d ose- li miti n g o bser vati o n of t hr o m b oc yt o pe nia was 
o bser ve d. G 3 a n d G 4 he mat ol o gic e ve nts occ urre d i n d ose le vels ra n gi n g fr o m 0. 8 t o 
1 8 m g/ k g wit h o ut a p pare nt d ose relati o ns hi p. Mil d t o m o derate platelet decreases see n i n t he 
maj orit y  of partici pa nts ge nerall y occ urre d o n d osi n g da ys a n d rec o vere d t o baseli ne le vels. 
U p date d i nf or mati o n ca n be f o u n d i n t he c urre nt I B.
2. 2. 3. 2. Cli nic al Acti vit y
P F - 0 7 9 0 1 80 1 has de m o nstrate d si n gle a ge nt cli nical acti vit y  i n s o me of t he 4 3 partici pa nts 
wit h a d va nce d R / R l ym p h o ma e nr olle d i n St u d y  C 4 9 7 1 0 0 1. As of 1 2 A pril 2 0 2 1 , a 3 3 % 
O R R has bee n o bser ve d i n 2 7 res p o nse- e val ua ble partici pa nts e nr olle d acr oss d oses ra n gi n g 
fro m 0. 8 - 1 8 m g / k g wee kl y. T here a p pears t o be a ra pi d o nset of res p o nse, wit h P R or C R 
t ypicall y n ote d b y Wee k 8 of treat me nt i n t his patie nt p o p ulati o n.
I n res p o n di n g partici pa nt s, t here were 2 wit h C R a n d 1 wit h near -C R:

O ne partici pa nt wit h D L B C L  a n d f o ur pri or li nes of t hera p y treate d wit h P F-
0 7 9 0 1 8 0 1 at 0. 8 m g/ k g wee kl y e x perie nce d P R at Wee k 8 a n d C R at Wee k 3 6. At 
m ore t ha n 2 2 m o nt hs si nce i nitiati o n of treat me nt, t he partici pa nt re mai ns o n st u d y i n 
C R wit h o ut P D u n de r a m o difie d treat me nt re gi me n of a si n gle i nf usi o n per m o nt h.

O ne partici pa nt wit h C T C L  wit h lar ge cell tra nsf or mati o n a n d si x pri or li nes of 
t hera py treate d wit h P F -0 7 9 0 1 8 0 1 at 1 8 m g/ k g wee kl y e x perie nce d a C R at Wee k 8; 
t he partici pa nt c o nti n ues o n st u dy u n der a re d uce d sc he d ule of o ne i nf usi o n e ver y 
2 1 da y s.

A t hir d partici pa nt wit h D L B C L a n d t hree pri or re gi me ns treate d wit h P F - 0 7 9 0 1 8 0 1 
at 4 m g/ k g wee kl y, ha d a 1 0 0 % re d ucti o n i n tar get lesi o ns at Wee k 8 b ut was 
declare d P R d ue t o mi ni mal resi d ual si g na l o n P E T i ma gi n g. T he partici pa nt 
c o nti n ue d o n st u d y a n d de vel o pe d P D at Wee k 2 4.
Cli nical acti vit y wit h P F - 0 7 9 0 1 8 0 1 as of t he data c ut- off of 1 2 A pril 2 0 2 1 is s u m marize d i n 
Ta ble 2. U p date d i nf or mati o n ca n be f o u n d i n t he c urre nt I B.
T a ble 2 .
Cli nic al Acti vit y wit h P F - 0 7 9 0 1 8 0 1 M o n ot her a p y at D oses R a n gi n g fr o m 
0. 8 -1 8 m g/ k g - St u d y C 4 9 7 1 0 0 1 ( as of 1 2 A pril 2 0 2 1)
I n dic ati o n
Res p o nse -E v al u a ble P atie nt 
P o p ul ati o n ( N)
C R
P R
O R R
D L B C L
1 1
1 ( 9 %)
2 ( 1 8 %) 
3 ( 2 7 %)
P T C L
6
0 ( 0 %)
2 ( 3 3 %) 
2 ( 3 3 %)
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 3
T a ble 2 .
Cli nic al Acti vit y wit h P F - 0 7 9 0 1 8 0 1 M o n ot her a p y at D oses R a n gi n g fr o m 
0. 8 -1 8 m g/ k g - St u d y C 4 9 7 1 0 0 1 ( as of 1 2 A pril 2 0 2 1)
I n dic ati o n
Res p o nse -E v al u a ble P atie nt 
P o p ul ati o n ( N)
C R
P R
O R R
C T C L
4
1 ( 2 5 %) 
2 ( 5 0 %) 
3 ( 7 5 %)
F L
3
0 ( 0 %)
1 ( 3 3 %) 
1 ( 3 3 %)
H L
3
0 ( 0 %) 
0 ( 0 %)
0 ( 0 %)
T ot al
2 7
2 ( 7 %)
7 ( 2 6 %) 
9 ( 3 3 %)
2. 2. 3. 3. Cli nic al P h ar m ac ol o g y 
2. 2. 3. 3. 1. P F -0 7 9 0 1 8 0 1
Si n gle - a n d m ulti ple-d ose P K of P F -0 7 9 0 1 8 0 1 are bei n g e val uate d i n t he o n g oi n g St u d y  
C 4 9 7 1 0 0 1. As of t he data c ut off of 0 2 N o ve m ber 2 0 2 1, preli mi nar y  P K data of P F- 0 7 9 0 1 8 0 1 
were a vaila ble fr o m 4 6 partici pa nts t hat recei ve d 0. 0 5 m g / k g t o 1 8 m g/ k g Q W as a 1-h o ur 
c o nti n u o us IV i nf usi o n i n t he d ose escalati o n part. P F - 0 7 9 0 1 8 0 1 e x hi bite d a greater t ha n 
d ose -pr o p orti o nal i ncrease i n s y ste mic e x p os ures d ue t o tar get me diate d dr u g cleara nce. 
P F - 0 7 9 0 1 8 0 1 is eli mi nate d via n o n-s pecific Fc R n-me diate d pr ote ol yt ic de gra dati o n a n d 
tar get me diate d cleara nce. P o p ulati o n P K a nal yses usi n g data fr o m 4 9 partici pa nts s h o we d 
t hat a 2-c o m part me nt m o del wit h si m ulta ne o us li near a n d n o n -li near cleara nce a de q uately 
descri be d t he P K of P F- 0 7 9 0 1 8 0 1 acr oss all d oses. I m m u n o ge nicit y data fr o m 4 6 partici pa nts 
s u g gests l o w ( 9 %) o verall i nci de nce of A D As a gai nst P F-0 7 9 0 1 8 0 1 (as of 
1 9 N o ve m ber 2 0 2 1). E val uati o n of t he i m pact of A D A o n t he P K of P F -0 7 9 0 1 8 0 1 is still 
o n g oi n g.
2. 2. 3. 3. 2. T af asit a m a b
Mea n tr o u g h c o nce ntrati o ns ( ± S D) were 1 7 9 ( ± 5 3) μ g/ m L f oll o wi n g a d mi nistrati o n of 
tafasita ma b at 1 2 m g/ k g o n Da ys 1, 8, 1 5, a n d 2 2 i n C 1-C 3 ( pl us a n a d diti o nal d ose o n 
C 1 D 4), a n d 1 5 3 ( ± 6 8) μ g/ m L  f oll o wi n g a d mi nistrati o n of tafasita ma b at 1 2 m g/ k g o n Da y s 1 
a n d 1 5 fr o m C 4 o n war ds. O verall ma xi m u m tafasita ma b ser u m c o nce ntrati o ns were 
4 8 3 ( ± 1 0 9) μ g/ m L. T he t otal v ol u me of distri b uti o n f or tafasita ma b-c xi x was 9. 3 L 
( 9 5 % CI : 8. 6, 1 0). T he cleara nce of tafasita ma b was 0. 4 1 L / d a y ( C V: 3 2 %) a n d t½ was 
1 7 da y s ( 9 5 % CI : 1 5, 1 8).
B o d y wei g ht ( 4 0 t o 1 6 3 k g) has a si g nifica nt effect o n t he P K of tafasita ma b, wit h hi g her 
cleara nce a n d v ol u me of distri b uti o n e x pecte d wit h hi g her b o d y wei g ht. N o cli nicall y 
mea ni n gf ul differe nces i n t he P K of tafasita ma b were o bser ve d base d o n a ge ( 1 6 t o 9 0 ye ars), 
se x, mil d t o m o derate re nal i m pair me nt ( Cr Cl 3 0-8 9 m L / mi n esti mate d b y t he 
C oc kcr oft -Ga ult e q uati o n), or mil d he patic i m pair me nt ( T bili ≤U L N a n d A S T > U L N, or 
T bili > 1 -1. 5 × U L N wit h a n y  A S T).
N o cli nicall y  mea ni n gf ul differe nces i n tafasita ma b P K were o bserve d w he n use d 
c o nc o mita ntl y wit h le nali d o mi de.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 4
I n 2 4 5 patie nts treate d wit h tafasita ma b, n o treat me nt -e mer ge nt or treat me nt -b o oste d a nti -
tafasita ma b a nti b o dies were o bser ve d. Pre-e xisti n g a nti -tafasita ma b a nti b o dies were detecte d 
i n 1 7/ 2 4 5 patie nts ( 6. 9 %) wit h n o i m pact o n p har mac o ki netics, efficac y  or safety of 
tafasita ma b.2 2
2. 2. 3. 3. 3. Le n ali d o mi de
Le nali d o mi de is ra pi dl y  a bs or be d f oll o wi n g oral a d mi nistrati o n wit h a me dian ser u m T ma x
ra n gi n g fr o m 0. 5 t o 1 h o ur wit h > 9 0 % oral bi oa vaila bilit y. Le nali d o mi de A U C a n d C ma x
val ues i ncrease d pr o p orti o nall y  wit h d ose fr o m 5 m g t o 4 0 0 m g i n dicati n g li near P K. 
C oa d mi nistrati o n of le nali d o mi de wit h a hi g h -fat meal re d uce d t he e xte nt an d rate of 
le nali d o mi de oral a bs or pti o n, h o we ver, t he effect of f o o d was c o nsi dere d n ot cli nicall y 
si g nifica nt, a n d t h us le nali d o mi de ca n be ta ke n wit h or wit h o ut f o o d. T he mea n half-life of 
le nali d o mi de is 3 t o 5 h o urs i n partici pa nts wit h M M.2 0 ,2 1
Le nali d o mi de bi n di n g t o plas ma pr otei ns is a p pr o xi matel y  3 0 % a n d t he a p pare nt v ol u me of 
distri b uti o n is 7 4 - 9 1 L. Le nali d o mi de is als o prese nt i n se me n after t he a d mi nistrati o n of a 
2 5 m g Q D d ose. H o we ver, t he le nali d o mi de t otal a m o u nt of dr u g prese nte d i n se me n o v er 
7 2 h o urs was < 0. 0 1 %. 2 1
Le nali d o mi de is eli mi nate d pri maril y via re nal cleara nce wit h ~ 8 2 % of t he d ose e xcrete d i n 
uri ne, pre d o mi na ntl y as u nc ha n ge d dr u g. Le nali d o mi de re nal e xcreti o n was n ot sat ura ble 
o ver t he d ose ra n ge of 5 m g t o 4 0 0 m g. D ose a dj ust me nt is nee de d f or patie nts wit h re nal 
i m pair me nt. As creati ni ne cleara nce decreases, half-life i ncreases, a n d dr u g cleara nce 
decreases li nearl y. 2 1 I n a de dicate d re nal i m pair me nt st u d y, partici pa nts wit h m o derate a n d 
se vere i m pair me nt ha d a 3-f ol d i ncrease i n half-life a n d a 6 6 % t o 7 5 % decrease, res pecti vely, 
i n dr u g cleara nce c o m pare d t o healt hy partici pa nts . F or P hase 2 partici pa nts wit h m o derate 
re nal i m pair me nt (creati ni ne cleara nce ≥3 0 m L / mi n a n d < 6 0 m L/ mi n), le nali d o mi de will be 
starte d (a n d/ or re d uce d) t o 1 0 m g daily (see Secti o n 6. 1. 1. 3 ).
Le nali d o mi de u n der g oes li mite d meta b olis m. Mil d he patic i m pair me nt ( T bili > 1 - 1. 5 × U L N 
or A S T > U L N) di d n ot ha ve a cli nicall y  si g nifica nt effect o n t he P K of le nali d o mi de. 
A d diti o na ll y, a ge ( 3 9 t o 8 5 years), b o d y wei g ht ( 3 3 t o 1 3 5 k g), se x, a n d race di d n ot ha ve a 
cli nicall y rele va nt effect o n le nali d o mi de cleara nce i n a d ult partici pa nts.2 1
2. 2. 3. 3. 4. Dr u g - Dr u g I nter acti o ns Bet wee n P F-0 7 9 0 1 8 0 1 a n d T af asit a m a b or 
Le n ali d o mi de
O verall, t he ris k of cli nicall y  rele va nt D DI bet wee n P F-0 7 9 0 1 8 0 1 a n d tafasita ma b or 
le nali d o mi de is c o nsi dere d l o w.
P F - 0 7 9 0 1 8 0 1 is eli mi nate d via n o n-s pecific Fc R n -me diate d pr ote ol yt ic de gra dati o n a n d 
tar get me diate d cleara nce. D ue t o t he nat ure of t he lar ge m olec ule ( P F-0 7 9 0 1 8 0 1 is a f usi o n 
pr otei n), tafasita ma b or le nali d o mi de are n ot e x pecte d t o alter P F -0 7 9 0 1 8 0 1 P K.
Tafasita ma b is a m o n ocl o nal a nti b o d y , w hich is e x pecte d t o be eli mi nate d via n o n -s pecific 
cata b olic de gra dati o n. Le nali d o mi de is mai nl y  eli mi nate d via re nal cleara nce. T heref ore, 
P F - 0 7 9 0 1 8 0 1 is n ot e x pecte d t o i m pact t he P K of tafasita ma b or le nali d o mi de. I n a d diti o n, 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 5
per t he U S PI of tafasita ma b, n o cli nicall y mea ni n gf ul differe nces i n tafasita ma b P K were 
o bser ve d w he n use d c o nc o mita ntl y  wit h le nali d o mi de. 
C ollecti o n of P K sa m ples f or P F- 0 7 9 0 1 8 0 1, tafasita ma b a n d le nali d o mi de is pla n ne d i n t his 
st u d y.
2. 3. Be nefit/ Ris k Assess me nt
T he c o m bi nati o n of P F -0 7 9 0 1 8 0 1 wit h t he pr o p ose d a ge nts (tafasita ma b a n d le nali d o mi de) is 
e x pecte d t o pr o vi de be nefit t o patie nts wit h R/ R D L B C L t hat ha ve pre vi o usl y  bee n treate d 
wit h sta n dar d of care d ue t o t he n o n -re d u n da nt M o A of t he differe nt c o m bi nati o n m olec ules, 
all le vera gi n g o n e n ha nce d acti vati o n of i m m u ne s y ste m effect ors.
P F -0 7 9 0 1 8 0 1 re p orte d si n gle a ge nt acti vit y  i n patie nts wit h a d va nce d R/ R D L B C L a n d is 
ge nerall y well t olerate d. T heref ore it is s u g geste d t hat it ma y  be a rele va nt ca n di date t o be 
c o m bi ne d wit h ot her acti ve a ge nts wit h o ut si g nifica ntl y  i ncreasi n g t he t o xicit y w hile 
e n ha nci n g t he acti vit y of ot her treat me nt re gi me ns, i ncl u di n g alrea d y  a p pr o ve d t hera pies. 
Base d o n P F- 0 7 9 0 1 8 0 1 cli nical data fr o m t he P hase 1 St u d y  C 4 9 7 1 0 0 1, a n d t he re p orte d A Es 
fr o m t he i nf or mati o n i n S m P Cs of t he c o m bi nati o n m olec ules (tafasita ma b a n d 
le nali d o mi de), ne utr o pe nia a n d t hr o m b oc yt o pe nia are p ossi ble o verla p pi n g t o xicities. T o 
mi ni mize ris ks patie nts will be m o nit ore d wit h wee kl y he mat ol o gic bl o o d tests f or at least 
t heir first 3 c ycles of treat me nt (see Secti o n 2. 3. 1 f or i de ntifie d ris ks a n d miti gati o ns) a n d 
s u bse q ue ntl y t wice m o nt hl y as per t he S o A a n d t he t o xicit y ma na ge me nt Secti o n 6. 6. 1 . 
M ore detaile d i nf or mati o n a b o ut t he k n o w n a n d e x pecte d be nefits a n d ris ks a n d
reas o na bly 
e x pecte d A Es of P F-0 7 9 0 1 8 0 1 ma y  be f o u n d i n t he I B, w hic h is t he S R S D f or t his st u d y. T he 
S R S Ds f or tafasita ma b a n d le nali d o mi de are t he c urre nt E U MI NJ U VI ® a n d R E V LI M I D® 
S m P Cs, res pecti vel y .2 0 ,2 2 T he S R S D f or fl u de o x y gl uc ose ( 1 8F) is t he E U S m P C. T he S R S Ds 
f or t he pre-me dicati o ns are t he Irela n d S m P Cs f or paraceta m ol, di p he n h y dra mi ne 
h y dr oc hl ori de, ci meti di ne a n d met h y l pre d nis ol o ne.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 6
2. 3. 1. Ris k Assess me nt
P hase 2 of t he st u d y will n ot be i nitiate d per b usi ness decisi o n ma de b y Pfizer ( pr ot oc ol a me n d me nt 2).
P ote nti al Ris k of Cli nic al 
Si g nific a nce
S u m m ar y of D at a/ R ati o n ale f or Ris k *
Miti g ati o n Str ate g y
P F -0 7 9 0 1 8 0 1 +t af asit a m a b + le n ali d o mi de
T hr o m b oc yt o pe nia
G 3 -4 t hr o m b oc yt o pe nia wa s o bser ve d i n 1 7. 3 % of t he 
patie nts treate d wit h tafasita ma b a n d le nali d o mi de. 6
Treat me nt- relate d G 3-4 t hr o m b oc yt o pe nia ( 5 %) has bee n 
re p orte d wit h P F-0 7 9 0 1 8 0 1 i n t he o n g oi n g P hase 1 S t u d y 
C 4 9 7 1 0 0 1. T he c o m bi nati o n ma y i ncrease t he ris k of 
G 3 -4 t hr o m b oc yt o pe nia.
Partici pa nts m ust ha ve a de q uate he mat ol o gical f u ncti o ns 
(i ncl u di n g platelet c o u nts wit h n o tra nsf usi o ns f or at least 2 
wee ks pri or t o C 1 D 1) t o be eli gi ble t o partici pate i n t his 
st u d y. Partici pa nts will ha ve wee kl y he mat ol o g y bl o o d tests 
f or t he first 3 c ycles a n d t hereafter e ver y t wo wee ks ( or 
m o re fre q ue ntl y if cli nicall y i n dicate d). 
Platelet tra nsf usi o n is all o we d t o ma na ge se vere 
t hr o m b oc yt o pe nia, t o pre ve nt a n d mi ni mize blee di n g 
acc or di n g t o i nstit uti o nal g ui deli nes (see Secti o n 6. 9. 4 ).
D ose i nterr u pti o n a n d d ose m o dificati o n are descri be d i n 
Secti o n 6. 6. 1 .
Ne utr o pe nia
G 3 -4 ne utr o pe nia was re p orte d i n 4 8. 1 % of t he patie nts 
treate d wit h tafasita ma b a n d le nali d o mi de.6
Treat me nt relate d, G 3 -4 ne utr o pe nia ( 9 %) has bee n 
re p orte d wit h P F-0 7 9 0 1 8 0 1 i n t he o n g oi n g P hase 1 St u d y 
C 4 9 7 1 0 0 1. T he c o m bi nati o n ma y i ncrease t he ris k of 
G 3- 4 ne utr o pe nia.
Partici pa nts m ust ha ve a de q uate he mat ol o gical f u ncti o ns 
(i ncl u di n g ne utr o p hil c o u nts, wit h n o gr o wt h fact or f or at 
least 2 wee ks pri or t o C 1 D 1) t o be eli gi ble t o partici pate i n 
t his st u d y. Partici pa nts will ha ve wee kl y he mat ol o g y bl o o d 
tests f or t he first 3 c ycles a n d t hereafter e ver y t w o wee ks 
( or m o re fre q ue ntl y if cli nicall y i n dicate d).
Pr o p h ylactic use of gra n ul oc yte -c ol o n y sti m ulati n g fact ors 
is n ot per mitte d d uri n g t he D L T peri o d of P hase 1 b b ut ca n 
be use d i n later c ycles a n d i n P hase 2 of t he st u d y. G -C S F 
ma y be use d t o treat treat me nt e mer ge nt ne utr o pe nia as per 
i nstit uti o nal g ui deli nes.
A n y s y m pt o ms or si g ns of de vel o pi n g i nfecti o n s h o ul d be 
a ntici pate d, e val uate d a n d treate d.
D ose i nterr u pti o n a n d d ose m o dificati o n are descri be d i n 
Se cti o n 6. 6. 1 .
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 7
P ote nti al Ris k of Cli nic al 
Si g nific a nce
S u m m ar y of D at a/ R ati o n ale f or Ris k *
Miti g ati o n Str ate g y
P F -0 7 9 0 1 8 0 1 +t af asit a m a b + le n ali d o mi de
A ne mia 
G 3 -4 a ne mia was o bser ve d i n 7. 4 % of t he patie nts 
treate d wit h tafasita ma b a n d le nali d o mi de.6
Decreases i n he m o gl o bi n a n d he mat ocrit w ere o bser ve d 
i n precli nical a ni mal st u dies wit h P F-0 7 9 0 1 8 0 1, 
h o we ver, gi ve n t he l o w affi nit y of P F -0 7 9 0 1 8 0 1 f or 
h u ma n R B Cs relati ve t o m o n ke y R B Cs, seri o us 
treat me nt-e mer ge nt a ne mia is n ot e x pecte d i n h u ma n 
partici pa nts. I n cli nical data as of 1 2 A pril 2 0 2 1, 1 of 4 3 
treate d partici pa nts e x perie nce d G 3 a ne mia t hat was 
assesse d b y t he i n vesti gat or as relate d t o P F -0 7 9 0 1 8 0 1. 
N o i nci de nce of a ne mia was assesse d b y t he i n vesti gat or 
as a n S A E a n d a ne mia di d n ot a p pear t o be ass ociate d 
wit h i ncrease d destr ucti o n of er yt hr oc ytes.
Partici pa nts m ust ha ve a de q uate he mat ol o gical f u ncti o ns 
(i ncl u di n g he m o gl o bi n, wit h n o tra nsf usi o n or 
er yt hr o p oiesis -sti m ulati n g a ge nt f or at least 2 wee ks pri or 
t o C 1 D 1) t o be eli gi ble t o partici pate i n t his st u d y. 
All partici pa nts will be cl osel y m o nit ore d f or a ne mia. 
Partici pa nts will ha ve wee kl y he mat ol o g y bl o o d tests f or 
t he first 3 c ycles a n d t hereafter e ver y t w o wee ks ( or m ore 
fre q ue ntl y if cli nicall y i n dicate d).
Pr o p h ylactic use of er yt hr o p oieti n or tra nsf usi o ns are n ot 
per mitte d d uri n g t he D L T peri o d of P hase 1 b b ut ca n be 
use d i n later c ycles a n d i n P hase 2 of t he st u d y, per 
i nstit uti o nal g ui deli nes ( n ote: er yt hr o p oieti n is n ot 
a p pr o ve d f or t he treat me nt relate d a ne mia i n Ja pa n) .
Bl o o d tra nsf usi o n is all o we d t o ma na ge se vere a ne mia 
acc or di n g t o i nstit uti o nal g ui deli nes (see Secti o n 6. 9. 4 ).
D ose i nterr u pti o n a n d d ose m o dificati o n are descri be d i n 
Secti o n 6. 6. 1 .
I R R
I n t he L-MI N D st u d y, tafasita ma b I R Rs (all G 1) were 
o bser ve d i n 5 ( 6 %) patie nts, a n d all occ urre d o nce d uri n g 
t he first i nf usi o n a n d n o disc o nti n uati o n of i nf usi o n was 
re q uire d.6
I R R wit h P F-0 7 9 0 1 8 0 1 has n ot bee n pre vale nt i n t he 
o n g oi n g St u d y C 4 9 7 1 0 0 1, w he n a d mi nistere d w it h 
pre me dicati o ns (see I B f or c urre nt data).   
Tafasita ma b: Pre me dicati o ns t o re d uce t he ris k of I R Rs are 
t o be a d mi nistere d 3 0 mi n utes t o 2 h o urs pri or t o 
tafasita ma b i nf usi o n. F or partici pa nts n ot e x perie nci n g 
I R Rs d uri n g t he first 3 i nf usi o ns, pre-me dicati o n is o pti o nal 
f or s u bse q ue nt i nf usi o ns. 
P F -0 7 9 0 1 8 0 1: n o pre -me dicati o ns are re q uire d ( u nless 
re q uire d b y i nstit uti o nal g ui deli nes or if pre vi o us I R R has 
bee n e x perie nce d). 
See Ta ble 9 f or treat me nt of I R Rs.
I nfecti o ns 
Fatal a n d seri o us i nfecti o ns ( 1 0 %), i ncl u di n g 
o p p ort u nistic i nfecti o ns, occ urre d i n patie nts d uri n g 
treat me nt wit h tafasita ma b a n d le nali d o mi de. Uri nar y 
tract i nfecti o ns were c o m m o n [ G 3 ( 4 %) a n d G 4 ( 1 %)].6
St u d y i nter ve nti o n(s) ma y be a d mi nister e d t o partici pa nts 
wit h a n acti ve i nfecti o n o nl y if t he i nfecti o n is treate d 
a p pr o priatel y a n d well c o ntr olle d. I nfecti o ns at ti me of 
scree ni n g t hat re q uire s yste mic treat me nt is a n e xcl usi o n 
criteri o n.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 8
P ote nti al Ris k of Cli nic al 
Si g nific a nce
S u m m ar y of D at a/ R ati o n ale f or Ris k *
Miti g ati o n Str ate g y
P F -0 7 9 0 1 8 0 1 +t af asit a m a b + le n ali d o mi de
Ne utr o pe nia (a n o verla p pi n g t o xicit y wit h P F -0 7 9 0 1 8 0 1 
a n d le nali d o mi de) ma y i ncrease ris k f or i nfecti o ns.
Partici pa nts wit h a hist or y of rec urri n g or c hr o nic i nfecti o ns 
ma y be at i ncrease d ris k of i nfecti o n a n d s h o ul d be 
m o nit ore d a p pr o priatel y.
Partici pa nts will be a d vise d t o c o ntact t heir healt hcare 
pr ofessi o nals if fe ver or ot her e vi de nce of p ote ntial 
i nfecti o n, s uc h as c hills, c o u g h or pai n o n uri nati o n, 
de v el o ps. Sites ma y use pr o p h yla xis a ge nts f or i nfecti o ns 
per i nstit uti o nal g ui deli nes ( Secti o n 6. 9. 6 ). 
T here is n o data a vaila ble i n HI V patie nts. C o nti n ue HI V 
a ntiretr o viral t hera p y a n d m o nit or HI V patie nts f or HI V -
relate d si g ns a n d s y m pt o ms s u g gesti n g viral re-acti vati o n. 
La b orat or y m o nit ori n g (e g, C D 4 c o u nts a n d HI V viral 
l oa d) ma y be re q uire d as per sta n dar d of care at t he 
i nstit uti o n.
Terat o ge nicit y
Le nali d o mi de is str uct urall y relate d t o t hali d o mi de. 
T hali d o mi de is a k n o w n h u ma n terat o ge nic acti ve 
s u bsta nce t hat ca uses se vere life-t hreate ni n g birt h 
defects. If le nali d o mi de is ta ke n d uri n g pre g na nc y, a 
terat o ge nic effect of le nali d o mi de i n h u ma ns is e x pecte d. 
F oll o w  pr ot oc ol g ui deli nes f or c o ntrace pti o n re q uire me nts 
a n d t he P P P set b y t he ma n ufact urer f or le nali d o mi de. See 
Secti o n 5. 3. 1 a n d Secti o n 1 0. 4. 5 .
Ma n dat or y c o ntrace pti o n will be i m ple me nte d i n W O C B P 
a n d males (see Secti o n 1 0. 4 ).
I n a d diti o n, a n y ot her P P P or a p plica ble pr o gra m re q uire d 
per l ocal re g ulati o ns m ust be f oll o w e d.
Ve n o us a n d arterial 
t hr o m b oe m b olis m
D L B C L is ass ociate d wit h i ncrease d ve n o us 
t hr o m b oe m b olis m, partic ularl y i n t he el derl y.2 3
Le nali d o mi de has de m o nstrate d a si g nifica ntl y i ncrease d 
ris k of D V T a n d P E, as well as of arterial 
t hr o m b oe m b olis m ( pre d o mi na ntl y m y ocar dial i nfarcti o n 
a n d cere br o vasc ular e ve nt). I n t he L -MI N D st u d y, 4 % of 
patie nts e x perie nce d G 3 -4 p ul m o nar y e m b olis m. 6
M o nit or f or a n d a d vise partici pa nts a b o ut si g ns a n d 
s y m pt o ms of t hr o m b oe m b olis m. A d vise partici pa nts t o 
see k i m me diate me dical care if t he y de vel o p s y m pt o ms 
s uc h as s h ort ness of breat h, c hest pai n, or ar m or le g 
s welli n g.
T hr o m b o pr o p h yla xis is rec o m me n de d t o be a d mi nistere d 
per R E V LI MI D ® S m P C  a n d i nstit uti o nal g ui deli nes, 
tail ore d t o t he partici pa nt’s i n di vi d ual ris k/ be nefit pr ofile 
b y ta ki n g i nt o acc o u nt t he i n di vi d ual t hr o m b otic a n d 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 9
P ote nti al Ris k of Cli nic al 
Si g nific a nce
S u m m ar y of D at a/ R ati o n ale f or Ris k *
Miti g ati o n Str ate g y
P F -0 7 9 0 1 8 0 1 +t af asit a m a b + le n ali d o mi de
blee di n g ris k or me dical hist or y a n d t he q ualit y of 
c o m plia nce wit h V T E pr o p h yla xis.
See Ta ble 8 f or d ose m o dificati o ns f or le nali d o mi de.
Aller gic reacti o ns a n d se vere s ki n 
reacti o ns
Cases of aller gic reacti o ns i ncl u di n g a n gi oe de ma, 
a na p h ylactic reacti o n a n d se vere c uta ne o us reacti o ns 
i ncl u di n g SJ S, T E N, a n d D R E S S ha ve bee n re p orte d i n 
partici pa nts treate d w it h le nali d o mi de.2 4 , 2 5
M o nit or f or a n d a d vise partici pa nts a b o ut si g ns a n d 
s y m pt o ms of t hese se vere reacti o ns. Dia g n ostic pr oce d ures 
ma y nee d t o be perf or me d as i n dicate d. A d vise partici pa nts 
t o see k me dical atte nti o n i m me diatel y if t he y de vel o p 
s y m pt o ms.
See Ta ble 8 f or d ose m o dificati o ns f or le nali d o mi de a n d 
S m P C 2 0 f or f urt her details.
T L S
Patie nts wit h hi g h t u m or b ur de n a n d ra pi dl y pr oliferati ve 
t u m or ma y be at i ncrease d ris k of t u m or l ysis s y n dr o me. 
I n patie nts wit h D L B C L, T L S d uri n g treat me nt wit h 
tafasita ma b has bee n o bser ve d. T L S is als o a k n o w n 
si de-effect of le nali d o mi de ( u n d er 1 %). 
A p pr o priate m o nit ori n g meas ures/ pr o p h yla xis i n 
acc or da nce wit h l ocal g ui deli nes s h o ul d be i m ple me nte d; 
all o p uri n ol/ras b uricase ma y be a d mi nistere d as per 
R E V LI MI D ® S m P C 2 0 or i nstit uti o nal g ui deli nes f or t u m or 
l ysis pr o p h yla xis or treat me nt 2 6.
Reacti vati o n of He patitis B vir us
Cases of viral reacti vati o n ha ve bee n re p orte d i n patie nts 
recei vi n g le nali d o mi de, i ncl u di n g seri o us cases of H B V 
reacti vati o n. See c urre nt Prescri bi n g I nf or mati o n f or 
le nali d o mi de.2 0
He patitis B vir us stat us m ust be esta blis he d bef ore 
i nitiati n g treat me nt wit h le nali d o mi de. Ca uti o n m ust be 
e xercise d w he n le nali d o mi de is use d i n partici pa nts 
pre vi o usl y i nfecte d wit h H B V, i ncl u di n g partici pa nts w h o 
are a nti-H Bc A b p ositi ve b ut H Bs A g ne gati ve. T hese 
partici pa nts m ust be cl osel y m o nit ore d f or si g ns a n d 
s y m pt o ms of acti ve H B V i nfecti o n t hr o u g h o ut t hera p y.
Reacti vati o n of her pes z oster vir us
Cases of viral reacti vati o n ha ve bee n re p orte d i n patie nts 
recei vi n g le nali d o mi de, i ncl u di n g seri o us cases of her pes 
z oster reacti vati o n. See c urre nt Prescri bi n g I nf or mati o n 
f or le nali d o mi de. 2 0
C o nsi der te m p orar y h ol d or per ma ne nt disc o nti n uati o n of 
t he treat me nt wit h le nali d o mi de a n d a de q uate a nti viral 
treat me nt.
* Refere nce c urre nt S R S D f or i nci de nce of ris ks
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 0
2. 3. 2. Be nefit Assess me nt
B y  e n ga gi n g o verla p pi n g as well as differe nt mec ha nis ms wit h t he c o m bi nati o n of 
tafasita ma b a n d le nali d o mi de, P F-0 7 9 0 1 8 0 1 is e x pecte d t o i ncrease a nti -t u m or acti vit y i n 
patie nts wit h R/ R D L B C L. As C D 4 7 pre dicts p o or pr o g n osis f or patie nts’ o utc o me, t here is 
p ote ntial f or t he a d diti o n of P F - 0 7 9 0 1 8 0 1 t o a d dress si g nifica nt u n met me dical nee ds, 
partic ularl y i n c o m bi nati o ns w here e n ha nce d cli nical effect is e x pecte d f or i m pr o ve d efficac y  
o utc o mes wit h a n a ntici pate d acce pta ble safet y pr ofile.
Patie nts wit h R/ R D L B C L w h o are n ot ca n di dates f or A S C T d ue t o a ge or c o -m or bi dities 
ha ve li mite d treat me nt o pti o ns a n d p o or pr o g n osis. T he c o m bi nati o n of tafasita ma b a n d 
le nali d o mi de has s h o w n i ncrease d res p o nse a n d pr o gressi o n -free s ur vi val i n patie nts wit h 
R/ R D L B C L lea di n g t o accelerate d a n d c o n diti o nal a p pr o val. T he c o m bi nati o n wit h 
P F -0 7 9 0 1 8 0 1 has t he p ote ntial t o f urt her e n ha nce cli nical be nefit wit h a n acce pta ble a n d 
ma na gea ble safet y pr ofile.
2. 3. 3. O ver all Be nefit/ Ris k C o ncl usi o n
Ta ki n g i nt o acc o u nt t he p ote ntial ris ks i de ntifie d c o m bi ni n g P F -0 7 9 0 1 8 0 1 wit h tafasita ma b 
a n d le nali d o mi de a n d t he meas ures t o mi ni mize t he a ntici pate d ris ks t o st u d y partici pa nts t his 
st u d y is j ustifie d b y t he p ote ntial be nefits i n partici pa nts wit h R/ R D L B C L.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 1
3. O B J E C TI V E S, E N D P OI N T S, A N D E S TI M A N D S
P hase 2 of t he st u d y will n ot be i nitiate d per b usi ness decisi o n ma de b y Pfizer ( pr ot oc ol a me n d me nt 2).
P H A S E 1 b
O bjecti ves
E n d p oi nts
Esti m a n ds a
Pri m ar y
T o assess D L Ts, safet y a n d t olera bilit y of 
P F -0 7 9 0 1 8 0 1 i n c o m bi nati o n wit h 
tafasita ma b a n d le nali d o mi de i n a d ult 
partici pa nts wit h R/ R D L B C L i n or der t o 
select u p t o 2 d oses of P F -0 7 9 0 1 8 0 1 f or 
f urt her e val uati o n i n P hase 2 of t he st u d y.
D L Ts d uri n g t he D L T o bser vati o n peri o d ( 2 8 da ys f oll o w i n g 
C 1 D 1).
D L T rate esti mate d base d o n data fr o m 
D L T -e val ua ble partici pa nts d uri n g t he 
D L T o bser vati o n peri o d ( 2 8 da ys 
f oll o wi n g C 1 D 1).
Sec o n d ar y 
T o e val uate t he o verall safet y pr ofile of 
t he c o m bi nati o n.

A E s as c haracterize d b y t y pe, fre q ue nc y, se verit y (as gra de d b y 
N CI C T C A E v 5. 0), ti mi n g, seri o us ness, a n d relati o ns hi p t o 
st u d y treat me nt.

La b orat or y a b n or malities as c haracterize d b y t y pe, fre q ue nc y, 
se verit y (as gra de d b y N CI C T C A E v 5. 0), a n d ti mi n g.
N A
T o e val uate t he a nti-t u m or acti vit y of 
P F -0 7 9 0 1 8 0 1 i n c o m bi nati o n wit h 
tafasita ma b a n d le nali d o mi de.
O R, D o R, C R, D o C R, a n d P F S per L u ga n o Res p o nse Classificati o n 
Criteria 2 0 1 4 as assesse d b y t he i n vesti gat or.
N A
T o e val uate t he P K of P F -0 7 9 0 1 8 0 1.
Pre - a n d p ost-d ose c o nce ntrati o n of P F -0 7 9 0 1 8 0 1.
N A
T o e val uate i m m u n o ge nicit y of 
P F -0 7 9 0 1 8 0 1.
A D As a n d N A bs a gai nst P F -0 7 9 0 1 8 0 1.
N A
Terti ar y/ E x pl or at or y
T o e val uate t he P K of tafasita ma b a n d 
le nali d o mi de.
Pre -d ose c o nce ntrati o ns of tafasita ma b a n d le nali d o mi de.
N A
T o e val uate i m m u n o ge nicit y of
tafasita ma b.
A D As a n d N A bs a gai nst tafasita ma b.
N A
T o u n dersta n d t he relati o ns hi p bet w ee n 
t he t hera pe utic i nter ve nti o n(s) bei n g 
st u die d a n d t he bi ol o g y of t he 
partici pa nt’s disease.
 
 o btai ne d at baseli ne, 
o n treat me nt a n d/ or at e n d of st u d y.
N A
a.
See details of t he esti ma n d i n Secti o n 9. 2. 1. 1 .
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)
C CI

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 2
P H A S E 2 
O bjecti ves
E n d p oi nts
Esti m a n ds a
Pri m ar y
T o assess t he cli nical a nti -t u m or acti vit y 
of P F -0 7 9 0 1 8 0 1 i n c o m bi nati o n wit h 
tafasita ma b a n d le nali d o mi de.
O R per L u ga n o Res p o nse Classificati o n Criteria 2 0 1 4 as asses se d 
b y t he i n vesti gat or.
T he treat me nt effect of P F -0 7 9 0 1 8 0 1 i n 
c o m bi nati o n wit h tafasita ma b a n d 
le nali d o mi de o n O R per t he L u ga n o 2 0 1 4 
res p o nse criteria as deter mi ne d b y 
i n vesti gat or assess me nt fr o m t he date of 
first d ose u ntil t he first d oc u me ntati o n of 
P D, deat h, or start of ne w  a ntica ncer 
t hera p y. Partici pa nts w h o d o n ot ha ve a 
p ost -baseli ne disease assess me nt d ue t o 
earl y P D, wh o recei ve a ntica ncer t hera pies 
ot her t ha n t he st u d y i nter ve nti o n pri or t o 
ac hie vi n g a n o bjecti ve res p o nse, or w h o 
die, e x perie nce P D, or st o p disease 
assess me nts f or a n y reas o n pri or t o 
ac hie vi n g a n o bjecti ve res p o nse will be 
c o u nte d as n o n -res p o n ders.
Sec o n d ar y
T o assess a d diti o nal efficac y o utc o mes of 
P F -0 7 9 0 1 8 0 1 i n c o m bi nati o n wit h 
tafasita ma b a n d le nali d o mi de.
D o R, C R, D o C R a n d P F S b y i n vesti gat or per L u ga n o Res p o nse 
Classificati o n Criteria 2 0 1 4.
N A
Select t he R P 3 D f or P F -0 7 9 0 1 8 0 1 i n 
c o m bi nati o n wit h tafasita ma b a n d 
le nali d o mi de.
All e n d p oi nts i n t his st u d y.
N A
T o f urt her e val uate t he o verall safet y 
pr ofile a n d t olera bilit y of P F-0 7 9 0 1 8 0 1 i n 
c o m bi nati o n wit h tafasita ma b a n d 
le nali d o mi de.

A E s as c haracterize d b y  t ype, fre q ue nc y, se verit y (as gra de d 
b y N CI C T C A E v 5. 0), ti mi n g, seri o us ness, a n d relati o ns hi p t o 
st u d y treat me nt.

La b orat or y a b n or malities as c haracteriz e d b y t y pe, fre q ue nc y, 
se verit y (as gra de d b y N CI C T C A E v 5. 0), a n d ti mi n g.
N A
T o e val uate t he P K of P F -0 7 9 0 1 8 0 1.
Pre - a n d p ost-d ose c o nce ntrati o ns of P F -0 7 9 0 1 8 0 1.
N A
T o e val uate i m m u n o ge nicit y of 
P F -0 7 9 0 1 8 0 1.
A D As a n d N A bs a gai nst P F -0 7 9 0 1 8 0 1.
N A
Terti ar y/ E x pl or at or y
T o e val uate t he P K of tafasita ma b a n d 
le nali d o mi de.
Pre -d ose c o nce ntrati o ns of tafasita ma b a n d le nali d o mi de
N A
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 3
P H A S E 2 
O bjecti ves
E n d p oi nts
Esti m a n ds a
T o e val uate i m m u n o ge nicit y of
tafasita ma b.
A D As a n d N A bs a gai nst tafasita ma b.
N A
T o u n dersta n d t he relati o ns hi p bet w ee n 
t he t hera pe utic i nter ve nti o n(s) bei n g 
st u die d a n d t he bi ol o g y of t he 
partici pa nt’s disease.
 
 o btai ne d at baseli ne, 
o n treat me nt a n d/ or at e n d of st u d y.
N A
a.
See details of t he esti ma n d i n Secti o n 9. 2. 1. 2 .
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)
C CI

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 4
4. S T U D Y D E SI G N
4. 1. O ver all Desi g n
A b usi ness decisi o n was ma de b y Pfizer t o ter mi nate t he C 4 9 7 1 0 0 3 st u d y. T he reas o n f or 
st u d y ter mi nati o n is n ot d ue t o a n y safet y c o ncer ns or re q uests fr o m re g ulat or y a ut h orities. 
As a res ult of t his decisi o n, P hase 1 b will be disc o nti n ue d after t he last partici pa nt last visit 
a n d P hase 2 of t he st u d y will n ot be i nitiate d.
T his is a m ultice nter, i nter nati o nal, P hase 1 b/ 2 st u d y  of differe nt d oses of P F-0 7 9 0 1 8 0 1 i n 
c o m bi nati o n wit h tafasita ma b a n d le nali d o mi de i n partici pa nts wit h R/ R D L B C L  w h o ha ve 
c o m plete d at least 1 li ne of s yste mic treat me nt (at least 1 c o ntai ni n g a n a nti-C D 2 0 t hera p y), 
w h o are n ot ca n di dates f or hi g h d ose t hera p y/ A S C T. See Secti o n 1. 2 f or desi g n sc he ma.
T he P hase 1 b will be c o n d ucte d i n a p pr o xi matel y  2 0 partici pa nts. T he o bjecti ves of t he 
P hase 1 b are t o e val uate t he safet y a n d t olera bilit y, P K, P D of P F-0 7 9 0 1 8 0 1 i n c o m bi nati o n 
wit h sta n dar d d oses of tafasita ma b a n d le nali d o mi de a n d t o select d oses f or P hase 2.
A n escalati o n/ de -escalati o n a p pr oac h g ui de d b y m T PI -2 will be use d i n P hase 1 b t o 
deter mi ne t he P F - 0 7 9 0 1 8 0 1 M T D or R P 2 D ( 2 d ose le vels) i n c o m bi nati o n wit h tafasita ma b 
a n d le nali d o mi de, f or f urt her e val uati o n of t he fi xe d d oses f or efficac y  a n d safety i n P hase 2.
A mi ni m u m of 2 t o 4 D L T -e val ua ble (Secti o n 4. 3. 4 ) partici pa nts is re q uire d at eac h teste d 
d ose le vel of P F -0 7 9 0 1 8 0 1. A p pr o xi matel y  6 t o 9 D LT- e val ua ble partici pa nts will be treate d 
at t he M T D or hi g hest safe teste d d ose le vel f or P F -0 7 9 0 1 8 0 1 bef ore pr ocee di n g t o P hase 2.
F oll o wi n g c o m pleti o n of P hase 1 b of t he st u d y, if at least 2 d oses of P F - 0 7 9 0 1 8 0 1 are 
c o nsi dere d t olera ble, 2 d oses will be selecte d f or f urt her e val uati o n i n t he P hase 2. I n P has e 2 
of t he st u d y , partici pa nts m ust ha ve bee n e x p ose d t o 1 b ut n o m ore t ha n 2 li nes of pri or 
t hera pies. A p pr o xi matel y 5 0 partici pa nts will be ra n d o mize d 1: 1 i nt o 2 selecte d d oses of 
P F -0 7 9 0 1 8 0 1 i n c o m bi nati o n wit h sta n dar d d oses of tafasita ma b a n d le nali d o mi de t o f urt her 
c haracterize t he safet y a n d t olera bilit y of t he c o m bi nati o n a n d assess t he efficac y of eac h 
d ose le vel. 2 7
If o nl y 1 d ose of P F-0 7 9 0 1 8 0 1 is c o nsi dere d t olera ble after P hase 1 b beca use of safet y  or 
ot her reas o ns, a p pr o xi matel y  2 5 partici pa nts will be treate d at t he selecte d fi xe d d ose i n t he 
P hase 2 of t he st u d y.
E nr ol l me nt of partici pa nts wit h pri or C A R-T will i nitiall y be li mite d t o a p pr o xi matel y  3 t o 
6 partici pa nts; after re vie w of all a vaila ble safet y data a n d deter mi ne d safe, e nr ol lme nt o f 
f urt her partici pa nts will c o nti n ue. P ost C A R-T partici pa nts are t o pr o vi de l ocal C D 1 9 
e x pressi o n res ult (if a vaila ble) a n d tiss ue f or f ut ure ce ntral testi n g ( b ot h m ust be a sa m ple 
after C A R -T a n d pri or t o C 1 D 1). 
At t he s p o ns or’s discreti o n pr ocee di n g t o P hase 2 will be deter mi ne d u p o n c o m pleti o n of 
P hase 1 b. T he t otalit y  of data i ncl u di n g efficac y, safety, P K, P D, bi o mar ker, a n d ot her 
c o nsi derati o ns will be use d t o deter mi ne t he rec o m me n de d d oses f or f urt her de vel o p me nt i n 
t he P hase 2. 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 5
F or P hase 1 b a n d P hase 2, P F -0 7 9 0 1 8 0 1 a n d tafasita ma b treat me nt will c o nti n ue u ntil P D, 
n o n -t olera ble t o xicit y or deat h w hile le nali d o mi de will be a d mi nistere d f or u p t o 1 2 c ycles; if 
a partici pa nt wit h d oc u me nte d P D per L u ga n o criteria 2 7 c o nti n ues t o e x perie nce cli nical 
be nefit, st u d y  treat me nt wit h P F-0 7 9 0 1 8 0 1 a n d tafasita ma b ma y  c o nti n ue u ntil n o l o n ger 
cli nicall y be nefiti n g as per a ris k-be nefit assess me nt b y  t he i n vesti gat or (see Secti o n 8. 2 ). 
4. 2. Scie ntific R ati o n ale f or St u d y Desi g n
4. 2. 1. Di versit y of St u d y P o p ul ati o n
Alt h o u g h t he i nci de nce of D L B C L is hi g her i n Ca ucasia ns vers us Africa n-A merica ns 
( 8 2 % vs 7. 3 3 %), Africa n- A merica ns are dia g n ose d at a n a vera ge a ge 1 0 ye ars y o u n ger 
c o m pare d t o W hites, are m ore li kel y t o ha ve m ore a d va nce d disease at t he ti me of dia g n osis, 
a n d ha ve a w o rse o verall s ur vi val rate.2 8 T o e ns ure Africa n -A merica ns are a de q uatel y 
re prese nte d i n t his trial, eff orts will be ma de t o i ncl u de sites t hat ser ve Africa n-A merica n 
c o m m u nities. In a d diti o n, eff orts will be ma de t o i nitiate e d ucati o nal a n d recr uit me nt 
ca m pai g ns f oc use d o n t he Africa n -A merica n c o m m u nit y  if nee de d.
4. 2. 2. D ose Le vel Re vie w Meeti n g
D uri n g t he P hase 1 D L T peri o d, a D L R tea m , c o m p ose d b y s p o ns or pers o n nel, i ncl u di n g at 
least o ne me dically q ualifie d me m ber, t o get her wit h t he i n vesti gat ors t hat ha ve e nr olle d 
treate d st u dy partici pa nts i n t he s pecific c o h ort will re vie w c u m ulati ve safet y data after t he 
last partici pa nt i n eac h co h ort has bee n f oll o we d f or at least 2 8 da y s fr o m t he first d ose of t he 
c o m bi nati o n t hera p y. T his re vie w is se parate fr o m t he o n g oi n g safet y assess me nts r o uti nel y 
perf or me d b y t he s p o ns or ( Secti o n 9. 4. 5 ).
4. 2. 3. C h oice of C o ntr ace pti o n/ B arrier Re q uire me nts
T here are n o data o n t he use of tafasita ma b i n pre g na nt w o me n. H o we ver, I g G is k n o w n t o 
cr oss t he place nta a n d tafasita ma b ma y  ca use fetal B-cell de pleti o n base d o n p har mac ol o gical 
pr o perties. 
St u dies t o e val uate t he de vel o p me ntal t o xicit y  of P F-0 7 9 0 1 8 0 1 ha ve n ot bee n c o n d ucte d.
Le nali d o mi de is k n o w n t o ca use ris k f or se vere ma nifestati o ns of de vel o p me ntal t o xicit y  i n 
h u ma ns. T heref ore, t he use of a hi g hl y effecti ve met h o d of c o ntrace pti o n is re q uire d (see 
A p pe n di x 4 ). T he c o n diti o n s of t he P P P f or le nali d o mi de t hat ha ve bee n set b y t he 
ma n ufact urer ( Secti o n 1 0. 4. 5 ) m ust be f ulfille d f or all partici pa nts u nless t here is relia ble 
e vi de nce t hat t he partici pa nt d oes n ot ha ve c hil d beari n g p ote ntial. Refer als o t o t he l ocal 
prescri bi n g i nf or mati o n f or c o ntrace pti o n g ui deli nes f or le nali d o mi de. 2 0
T he d urati o n of t he c o ntrace pti o n re q uire d after t he la st d ose of st u d y i nter ve nti o n is 4 wee ks 
f or male partici pa nts a n d 9 0 da y s f or fe male partici pa nts; a n d c o ntrace pti o n s h o ul d be 
i nitiate d 4 wee ks bef ore t he start of st u d y i nter ve nti o n (see A p pe n di x 4 f or details). 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 6
4. 2. 4. C ollecti o n of Ret ai ne d Rese arc h S a m ples
Retai ne d Researc h Sa m ples will be c ollecte d a n d st ore d f or f urt her a nal ys es w hic h ma y, f or 
e xa m ple, pr o vi de greater u n dersta n di n g of t he st u d y  i nter ve nti o n.
4. 3. J ustific ati o n f or D ose
4. 3. 1. D osi n g Re gi me ns of P F - 0 7 9 0 1 8 0 1
P hase 2 of t he st u d y will n ot be i nitiate d per b usi ness decisi o n ma de b y Pfizer ( pr ot oc ol 
a me n d me nt 2).
As of 1 2 Dece m ber 2 0 2 1 ( Data Safet y U p date Re p ort c ut -off date), i n t he FI H St u d y  
C 4 9 7 1 0 0 1, P F -0 7 9 0 1 8 0 1 has bee n a d mi nistere d t o 6 7 partici pa nts wit h a d va nce d R/ R 
l ym p h o ma as m o n ot hera p y  i n 8 differe nt d ose-escalati o n c o h orts. D ose c o h orts ra n gi n g fr o m 
0. 0 5 m g/ k g t o 1 8 m g/ k g (e q ui vale nt t o 3. 7 5 m g t o 1 3 5 0 m g f or a 7 5 k g pers o n, res pecti vel y) 
Q W were well -t olerate d wit h n o M T D reac he d. T he c o m bi nati o n of P F -0 7 9 0 1 8 0 1 a n d 
tafasita ma b pl us le nali d o mi de has n ot pre vi o usl y bee n e val uate d. T he pr o p ose d starti n g d ose 
of P F -0 7 9 0 1 8 0 1 ( 4 m g / k g Q W f or C 1 t o C 3 t he n Q 2 W f or C 4 a n d o n war ds ) i n c o m bi nati o n 
wit h f ull d osi n g of tafasita ma b a n d le nali d o mi de is e x pecte d t o pr o vi de li mite d tar get 
e n ga ge me nt f or P F-0 7 9 0 1 8 0 1 a ntit u m or acti vit y  w hile it is 4. 5 ti mes l o wer relati ve t o t he 
ma xi m u m a d mi nistere d d ose of P F -0 7 9 0 1 8 0 1 ( 1 8 m g/ k g Q W) f or m o n ot hera p y  i n t he FI H 
St u d y  C 4 9 7 1 0 0 1. Preli mi nar y a nalys es s h o we d s ustai ne d tar get e n ga ge me nt at hi g her d ose 
le vels wit h d ose-de pe n de nt i ncrease i n rece pt or occ u pa nc y  d ura bilit y at t he e n d of d osi n g 
i nter val. F or e xa m ple, rece pt or occ u pa nc y f or d oses bel o w 4 m g / k g Q W decrease d t o 
s u bsta ntiall y l o wer le vels at t he e n d of t he d osi n g i nter val, e g, bel o w 1 0 % at 1. 0/ 2. 0 m g/ k g 
Q W d ose le vel.
I n P hase 2 of t he c urre nt st u d y C 4 9 7 1 0 0 3, a fi xe d d osi n g a p pr oac h will be use d i nstea d of 
b o d y  wei g ht ( B W T) base d d osi n g a p pr oac h use d i n t he FI H st u d y C 4 9 7 1 0 0 1 base d o n t he 
f oll o wi n g rati o nales:

B W T was f o u n d n ot t o be a si g nifica nt c o variate o n li near a n d n o n-li near cleara nce i n t he 
P o p ulati o n P K m o del.
A U C ta u n or malize d b y  t otal d ose ( m g) pr o vi de d a l o wer i nter-patie nt varia bilit y  ( 2-3 1 %) 
c o m pare d t o t he o bser ve d A U C ta u ( 2 3- 4 8 %) base d o n B W T d osi n g, s u g gesti n g a p ote ntial 
l o wer i nter-patie nt varia bilit y  i n P K wit h fi xe d d osi n g c o m pare d t o B W T base d d osi n g. Fi xe d 
d oses t o be e x pl ore d i n t he P hase 2 will be deter mi ne d u p o n c o m pleti o n of P hase 1 b. T he 
t otalit y of data i ncl u di n g efficac y, safety, P K, P D, bi o m ar kers, a n d ot her c o nsi derati o ns will 
be use d t o deter mi ne t he rec o m me n de d d oses ( L o w d ose a n d Hi g h d ose) f or f urt her d ose 
o pti mizati o n i n t he P hase 2.
4. 3. 2. D osi n g re gi me n of T af asit a m a b a n d Le n ali d o mi de
Tafasita ma b will be a d mi nistere d at 1 2 m g/ k g I V acc or di n g t o t he f oll o wi n g sc he d ule; eac h 
c ycle has 2 8 da ys.

C 1: Da y s 1, 4, 8, 1 5 a n d 2 2.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 7

C 2 a n d C 3 ( Q W): Da ys 1, 8, 1 5 a n d 2 2.

≥C 4 ( Q 2 W): Da y s 1 a n d 1 5.
T his is t he rec o m me n de d d osa ge a n d d osi n g sc he d ule i n t he U S PI  a n d E U S m P C of 
tafasita ma b i n c o m bi nati o n wit h le nali d o mi de f or t he treat me nt of a d ult patie nts wit h R/ R 
D L B C L, w h o are n ot eli gi ble f or A S C T.
Le nali d o mi de will be a d mi nistere d 2 5 m g P O dail y  o n Da ys 1 t hr o u g h 2 1 of eac h 2 8-d a y  
c ycle f or u p t o 1 2 c ycles. T his is t he d osa ge re gi me n use d i n t he L -MI N D st u d y , w hic h 
s u p p orte d t he accelerate d a n d c o n diti o nal a p pr o val of tafasita ma b i n c o m bi nati o n wit h 
le nali d o mi de f or t he treat me nt of a d ult patie nts wit h R/ R D LB C L N O S, i ncl u di n g D L B C L 
arisi n g fr o m l o w gra de l y m p h o ma, a n d w h o are n ot eli gi ble f or A S C T. T o re d u ce P K a n d 
safety assess me nt varia bilit y , partici pa nts wit h creati ni ne cleara nce < 6 0 m L/ mi n will be 
e xcl u de d i n t he P hase 1 b of t he st u d y  si nce le nali d o mi de e x p os ure a n d t he ris k f or hi g her 
he mat ol o gical a d verse reacti o ns or he pat ot o xicit y  i ncrease i n t his p o p ulati o n.
4. 3. 3. Criteri a f or D ose Esc al ati o n
T he pr o visi o nal d ose le vels of P F - 0 7 9 0 1 8 0 1 t o be e val uate d are liste d i n Ta ble 3 . 
T a ble 3. 
Pr o visi o n al D ose Le vels P F- 0 7 9 0 1 8 0 1 i n D ose -Esc al ati o n
C o h ort
D ose (m g / kg)
I ncre me nt ( %)
1 ( D L 1)
4 m g/ k g Q W f or C 1 t o C 3 t he n Q 2 W
X
2 ( D L 2)
1 0 m g/ k g Q W f or C 1 t o C 3 t he n Q 2 W 
1 5 0 %
3 ( D L 3)
1 8 m g/ k g Q W f or C 1 t o C 3 t he n Q 2 W
8 0 %
A d diti o nal P F -0 7 9 0 1 8 0 1 d oses, d ose le vels a n d/ or d osi n g fre q ue nc y or sc he d ule ma y be e x pl ore d.
Eac h c ycle is 2 8 da ys. Q W = D a y s 1, 8, 1 5 a n d 2 2. Q 2 W = Da y s 1 a n d 1 5.
T he d osi n g sc he d ule ma y als o be a dj uste d t o e x pa n d a d osi n g c o h ort t o f urt her e val uate 
safety, P K, a n d/ or P D fi n di n gs at a gi ve n d ose le vel or t o a d d c o h orts t o e val uate a d diti o nal 
d ose le vels. T he st u d y pr oce d ures f or t hese a d diti o nal partici pa nt(s)/c o h or t(s) will be t he 
sa me as t hat descri be d f or ot her st u dy partici pa nts/c o h orts.
If a partici pa nt e x perie nces a n o n-D L T e ve nt t hat re q uires a d ose hel d per d ose - m o dificati o n 
g ui deli ne a d diti o nal partici pa nts ma y  be e nr olle d. If D L 3 is n ot t olerate d a n a d diti onal c o h ort 
( D L 4) ma y be e x pl ore d at a d ose i nter me diate t o D L2 a n d D L 3. 
If after o ne c o h ort d ose le vel has bee n deter mi ne d safe a n d t he s u bse q ue nt d ose c o h ort is 
pe n di n g c o m pleti o n of its D L T peri o d, ne w eli gi ble partici pa nts ma y  be e nr olle d a n d 
‘ bac kfille d’ i nt o t he safe, pri or c o h ort. F or t hese a d diti o nal partici pa nts, t heir data will 
c o ntri b ute t o safet y a n d efficac y  a nalys es b ut t he y will n ot partici pate i n t he D LT al g orit h m. 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 8
4. 3. 4. D ose Li miti n g T o xicit y Defi niti o n
T he D L T o bser vati o n peri o d will be t he fir st 2 8-da y  c ycle of treat me nt i n eac h partici pa nt. A 
D L T is defi ne d as a n y  of t he f oll o wi n g T E A Es t hat are c o nsi dere d b y t he i n vesti gat or at least 
p ossi bl y  relate d t o a n y or all of t he c o m bi nati o n st u d y treat me nts. N ote t hat a n y A Es f or 
w hic h t he relati o ns h i p t o st u d y treat me nt ca n n ot be r ule d o ut s h o ul d be c o nsi dere d p ossi bl y 
relate d. All t o xicities t hat occ ur d uri n g t he st u dy will be acti vel y ma na ge d f oll o wi n g t he 
sta n dar d of care per l ocal i nstit uti o nal practice u nless ot her wise s pecifie d i n t he pr ot oc ol.
A partici pa nt is classifie d as D L T e val ua ble if t he y eit her 1) recei ve at least 8 0 % of t he 
pla n ne d d ose of P F - 0 7 9 0 1 8 0 1 a n d at least 7 5 % of t he pla n ne d d ose of tafasita ma b a n d 
le nali d o mi de a n d ha ve recei ve d t he maj ority of sc he d ule d safet y assess me nts d uri n g t he D L T 
o bser vati o n peri o d; or 2) ha ve e x perie nce d a D L T. T he perce nta ge of dr u g recei ve d is 
calc ulate d as t he perce nta ge of t he act ual t otal a m o u nt of dr u g(s) a d mi nistere d d uri n g t he 
D L T o bser vati o n peri o d i n relati o n t o t he pla n ne d t otal a m o u nt of dr u g(s) t o be a d mi nistere d 
f or t he D L T o bser vati o n peri o d.

A partici pa nt faili n g t o meet t hese criteria ma y  be re place d. If t he partici pa nt has 
misse d a mi n orit y  of safet y assess me nts d ue t o e mer ge nc y sit uati o ns (e g, site 
accessi bilit y iss ues, i na bilit y to g o t o a n e xter nal la b, etc.), t he D L R tea m ma y  j u d ge 
t he partici pa nt e val ua ble, de pe n di n g o n t he a b u n da nce of t he a vaila ble data.
F or t he p ur p ose of d ose escalati o n, a n y of t he treat me nt -relate d A Es defi ne d i n Secti o n 
4. 3. 4. 1 , occ urri n g i n t he first 2 8 da y s of treat me nt t hat i n t he o pi ni o n of t he i n vesti gat or 
ca n n ot be reas o na bl y attri b ute d t o t he partici pa nt’s u n derl yi n g disease, c o nc o mita nt 
me dicati o ns or pree xisti n g c o n diti o ns are c o nsi dere d D L Ts.
Se verit y  of A Es will be gra de d acc or di n g t o C T C A E v 5. 0. F or t h ose e ve nts i n v ol vi n g a 
w orse ni n g of a baseli ne a b n or malit y , a D L T m ust re prese nt a cli nically si g nifica nt (i n t he 
o pi ni o n of t he i n vesti gat o r after disc ussi o n wit h t he s p o ns or) s hift fr o m baseli ne:
4. 3. 4. 1. He m at ol o gic al D L Ts

G 4 t hr o m b oc y t o pe nia ( < 2 5, 0 0 0/ µ L) lasti n g > 7 2 h o urs or a platelet c o u nt ≤1 0, 0 0 0/ µ L  
at a n y ti me, u ne x plai ne d b y u n derl yi n g disease.

≥G 3 t hr o m b oc y t o pe nia ass ociate d wit h ≥G 2 blee di n g, u ne x plai ne d b y u n derl yi n g 
disease. 

G 4 a ne mia, u ne x plai ne d b y u n derl yi n g disease.
Pr o p h y lactic use of er yt hr o p oieti n or bl o o d pr o d ucts are n ot all o we d d uri n g t he 
D L T peri o d i n P hase 1 b.

G 4 ne utr o pe nia lasti n g ≥7 da y s, u ne x plai ne d b y u n derl yi n g disease.

G 3 fe brile ( > 3 8. 3° C) ne utr o pe nia lasti n g ≥7 da y s, u ne x plai ne d b y u n derlyi n g disease.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 9

G 4 fe brile ne utr o pe nia u ne x plai ne d b y  u n derlyi n g disease.
N ote : Pr o p h ylactic use of gra n ul oc yte-c ol o n y sti m ulati n g fact ors is n ot per mitte d 
d uri n g t he D L T peri o d of P hase 1 b, b ut t he y  ma y be use d t o treat treat me nt e mer ge nt 
ne utr o pe nia as per prescri bi n g i nf or mati o n.
4. 3. 4. 2. N o n -He m at ol o gic D L Ts

A n y  treat me nt-relate d ≥G 3 n o n -he mat ol o gic t o xicit y  (see bel o w f or s pecificati o ns 
a p pl yi n g t o s pecial circ u msta nces) wit h t he f oll o wi n g e xce pti o ns:
o
G 3 na usea, v o miti n g a n d diarr hea t hat i m pr o ve t o G 2 or better wit hi n 7 2 h o urs 
after s u p p orti ve care;
o
Tra nsie nt G 3 fati g ue lasti n g ≤7 da y s;
o
G 3 A Es t hat rec o ver t o baseli ne or G 1 wit hi n 3 da ys;
o
Tra nsie nt as y m pt o matic ≥G 3 la b orat or y ab n or malities c o nsi dere d n ot cli nicall y 
si g nifica nt f oll o wi n g a gree me nt bet wee n i n vesti gat ors a n d t he s p o ns or’s me dical 
m o nit or a n d starti n g t o rec o ver wit hi n 7 2 h o urs of t heir o nset wit h sta n dar d 
s u p p orti ve care;
o
H y perse nsiti vit y  that ca n be c o ntr olle d wit h me dical treat me nt a n d res ol ves t o 
as ym pt o matic ( ≤G 1) wit hi n 7 2 h o urs.

Ot her ≥G 2 P F - 0 7 9 0 1 8 0 1-relate d n o n- he mat ol o gic t o xicities t hat, i n t he o pi ni o n of 
t he i n vesti gat or, re q uire a d ose re d ucti o n or disc o nti n uati o n of P F-0 7 9 0 1 8 0 1 ma y  be 
c o nsi dere d a D L T.
4. 3. 5. M a xi m u m T oler a te d D ose
M T D is defi ne d as t he hi g hest d ose wit h tr ue D L T rate wit hi n t he EI of t he tar get D L T rate. 
T he tar get D L T rate is 0. 3, t he EI is ( 0. 2 5, 0. 3 5). 
4. 4. E n d of St u d y Defi niti o n
T he e n d of t he st u d y is defi ne d as t he date of t he last f oll o w- u p visit of t h e last partici pa nt i n 
t he gl o bal st u d y.
A partici pa nt is c o nsi dere d t o ha ve c o m plete d t he st u d y  if t he y ha ve c o m plete d all peri o ds of 
t he st u d y, i ncl u di n g t he last f oll o w- u p visit.
5. S T U D Y P O P U L A TI O N
T his st u d y  ca n f ulfill its o bjecti ves o nl y if a p pr o priate partici pa nts are e nr olle d , i ncl u di n g 
partici pa nts acr oss di verse a n d re prese ntati ve racial a n d et h nic bac k gr o u n ds. A prescree ni n g 
t o ol f or st u d y recr uit me nt p ur p oses will i ncl u de c ollecti o n of i nf or mati o n t hat reflects t he 
e nr oll me nt of a di verse partici pa nt p o p ulati o n i ncl u di n g, w here per mitte d u n der l ocal 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 0
re g ulati o ns, a ge, se x, a n d race, a n d et h nicity . T he f oll o wi n g eli gi bilit y criteria are desi g ne d t o 
select partici pa nts f or w h o m partici pati o n i n t he st u d y is c o nsi dere d a p pr o priate. All rele va nt 
me dical a n d n o n me dical c o n diti o ns s h o ul d be ta ke n i nt o c o nsi derati o n w he n deci di n g 
w het her a partic ular partici pa nt is s uita ble f or t his pr ot oc ol.
Pr os pecti ve a p pr o val of pr ot oc ol de viati o ns t o recr uit me nt a n d e nr oll me nt criteria, als o 
k n o w n as pr ot oc ol wai vers or e xe m pti o ns, is n ot per mitte d.
Pfizer will re vie w eli gi bilit y  criteria verifie d b y t he i n vesti gat or or q ualifie d desi g nee t o 
c o nfir m t hat partici pa nts meet st u d y  eli gi bilit y criteria bef ore t he y are ra n d o mize d i nt o t he 
st u d y. T he ra n d o mizati o n a p pr o val pr ocess will be i nitiate d f or a partici pa nt after a n 
I nf or me d C o nse nt D oc u me nt has bee n si g ne d a n d t he i n vesti gat or or q ualifie d desi g nee has 
assesse d t he partici pa nt as eli gi ble. T he ra n d o mizati o n a p pr o val will be base d o n re vie w of 
C R F/s y ste m data.
5. 1. I ncl usi on Criteri a
Partici pa nts are eli gi ble t o be i ncl u de d i n t he st u d y o nl y if all of t he f oll o wi n g criteria a p pl y:
A ge a n d Se x:
1.
Partici pa nts a ge d 1 8 ye ars of a ge or ol der ( or t he mi ni m u m a ge of c o nse nt i n 
acc or da nce wit h l ocal re g ulati o ns) at Scree ni n g.

Refer t o A p pe n di x 4 f or re pr o d ucti ve criteria f or male (Secti o n 1 0. 4. 1 ) a n d fe male 
(Secti o n 1 0. 4. 2 ) partici pa nts, a n d P P P ( Secti o n 1 0. 4. 5 ).
Dise ase C h ar acteristics:
2.
Hist ol o gical l y c o nfir me d, meas ura ble rela pse d a n d/ or refract or y D L B C L N O S, 
T cell/ histi oc yte ric h lar ge B-cell l y m p h o ma; or E B V p ositi ve D L B C L. acc or di n g t o 
t he 5t h e diti o n of t he W H O Classificati o n of L y m p h oi d Ne o plas ms.2 9 F urt her, 
f ollic ular l ym p h o ma gra de 3 b, or c o m p osite l y m p h o ma wit h a D L B C L c o m p o ne nt 
wit h a s u bse q ue nt D L B C L rela pse.

Partici pa nts wit h e vi de nce of hist ol o gical tra nsf or mati o n t o D L B C L  fr o m a n 
earlier dia g n osis of l o w gra de l y m p h o ma (ie, a n i n d ole nt pat h ol o g y  s uc h as 
f ollic ular l ym p h o ma, mar gi nal z o ne l y m p h o ma, c hr o nic l y m p h oc y tic le u ke mia) 
are eli gi ble if rela pse d or refract or y  t o at least o ne li ne of t hera p y f or D L B C L (f or 
pri mar y  refract or y, see e xcl usi o n criteri o n # 2 bel o w).
3.
Partici pa nt c haracteristics :

N ot a ca n di date per i n vesti gat or or u n willi n g t o u n der g o hi g h d ose c he m ot hera p y 
a n d s u bse q ue nt a ut ol o g o us ste m cell tra ns pla nt or u na ble t o recei ve a p pr o ve d 
C A R -T t hera p y (e g, l o gistical li mitati o ns). 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 1

Meas ura ble disease: at least 1 site of meas ura ble, P E T- a vi d disease per L u ga n o 
2 0 1 4 classificati o n (i n de x lesi o n: 1. 5 c m i n t he l o n gest dia meter f or n o dal, 
1. 0 c m i n t he l o n gest dia meter f or e xtra n o dal disease).
4.
Pri or s y ste mic treat me nt re gi me n: 

M ust i ncl u de a n a nti -C D 2 0 c o ntai ni n g re gi me n:

P hase 1 b: at l east 1 pri or li ne of s yste mic t hera p y.

P hase 2: at least 1 b ut n o m ore t ha n 2 pri or li nes of s y ste mic t hera p y.
F or b ot h p hases: i n d ucti o n, A S C T a n d c o ns oli dati o n will be c o nsi dere d o ne li ne 
of t hera p y;  bri d gi n g t hera p y pri or t o C A R-T a n d C A R -T treat me nt wi ll be 
c o nsi dere d t o get her as o ne li ne of t hera p y.

If e x p ose d t o pri or C D 1 9-tar geti n g C A R-T t hera p y :

Last C A R -T i nf usi o n m ust ha ve bee n c o m plete d > 9 0 da y s pri or t o C 1 D 1.

Pr o vi de C D 1 9 e x pressi o n test at Scree ni n g as per l ocal la b, if a vaila ble, a n d 
m ust pr o v i de a tiss ue sa m ple f or retr os pecti ve ce ntral testi n g (see als o 
i ncl usi o n criteri o n # 8 a n d Secti o n 8. 7. 8 ). C D 1 9 positi vit y  is n ot re q uire d.
5.
A de q uate or ga n f u ncti o n:

He mat ol o g y  ( wit h n o tra nsf usi o n or gr o wt h fact or s u p p ort f or at least 2 wee ks 
pri or t o C 1 D 1):

A N C ≥1, 0 0 0/ μ L .

Platelet c o u nt ≥9 0, 0 0 0/ μ L.

He m o gl o bi n ≥8 g/ d L.

He patic f u ncti o n:

T bili ≤2. 0 × U L N. Partici pa nts wit h d oc u me nte d Gil bert’s s y n dr o me are 
eli gi ble f or t his st u d y pr o vi di n g t he direct bilir u bi n is ≤U L N.

A L T a n d A S T ≤2. 5 × U L N.

Re nal f u ncti o n:

P hase 1 b: Esti mate d creati ni ne cleara nce ≥6 0 m L/ mi n per l ocal assess me nt.

P hase 2: Esti mate d creati ni ne cleara nce ≥3 0 m L / mi n per l ocal assess me nt. 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 2
N ote f or P hase 2: f or creati ni ne cleara nce ≥3 0 m L/ mi n a n d < 6 0 m L / mi n, 
le nali d o mi de is t o be starte d wit h a re d uce d d ose of 1 0 m g dail y.
6.
E C O G perf or ma nce stat us ≤2.
Ot her I ncl usi o n Criteri a:
7.
Res ol uti o n of ac ute effects of a n y pri or t hera p y t o eit her baseli ne se verit y or 
C T C A E v 5. 0 ≤ G 1 (e xce pt f or A Es n ot c o nstit uti n g a safet y ris k i n t he i n vesti gat or’s 
j u d g me nt).
8.
Partici pa nts are a ble t o pr o vi de t u m or tiss ue c ollecte d bef ore C 1 D 1 (fres h or arc hi va l) 
f or bi o mar ker a nalys is, u nless n ot per mitte d b y l ocal re g ulati o ns.
5. 2. E xcl usi o n Criteri a
Partici pa nts are e xcl u de d fr o m t he st u d y  if a n y of t he f oll o wi n g criteria a p pl y:
Me dic al C o n diti o ns:
1.
Pri or treat me nt wit h a nti -C D 4 7 or a nti -C D 1 9 ( ot her t ha n C A R -T) or 
i m m u n o m o d ulat or y a ge nts li ke t hali d o mi de or le nali d o mi de.
2.
Pri mar y  refract or y D L B C L:

Pri mar y  refract or y defi niti o n f or t his pr ot oc ol: res p o nse less t ha n a P R t o first -li ne 
t hera py or pr o gressi o n d uri n g or wit hi n 6 m o nt hs after c o m pleti o n of first li ne of 
t hera py.
3.
Hi g h -gra de l y m p h o ma (f or merl y k n o w n as ‘ d o u ble’ or ‘tri ple hit’ D L B C L) or C N S 
l ym p h o ma ( pri mar y  or sec o n dar y).

Si m ulta ne o us detecti o n of M Y C wit h B C L 2 a n d/ or B C L 6 tra nsl ocati o n(s) defi ne d 
b y  fl u oresce nce i n sit u h y bri dizati o n. M Y C, B C L 2, B C L 6 testi n g pri or t o st u d y 
e nr ollme nt is n ot re q uire d. FI S H testi n g is re q uire d pri or t o e nr oll me nt if 
hist orical res ults are n ot a vaila ble.

C N S l y m p h o ma i n v ol ve me nt – prese nt or past me dical hist or y
4.
A n y  hist or y of mali g na ncies ot her t ha n D L B C L e xce pt f or:

Basal c ell or s q ua m o us cell carci n o ma of t he s ki n or B o we n’s disease t hat has 
a de q uatel y bee n treate d.

A n y  pri or mali g na ncies ≥3 y ears bef ore ra n d o mizati o n wit h n o s u bse q ue nt 
e vi de nce of rec urre nce or pr o gressi o n wit h o ut treat me nt re gar dless of sta ge of 
disease.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 3

A n y  pri or mali g na ncies i n sit u, sta ge 0 – 1 ca ncer < 3 y ears bef ore ra n d o mizati o n 
t hat has a re m ote pr o ba bilit y of rec urre nce or pr o gressi o n per i n vesti gat or.
5.
Pri or ca ncer treat me nt, ra di ot hera p y wit hi n 2 wee ks or maj or s ur ger y wit hi n 2 wee ks.
6.
Pri or all o ge n eic ste m cell tra ns pla ntati o n; a ut ol o g o us ste m cell tra ns pla ntati o n wit hi n 
1 2 wee ks pri or t o e nr o ll me nt.
7.
Si g nifica nt car diac/car di o vasc ular/t hr o m b oe m b olic disease, s uc h as 

S y m pt o matic c o n gesti ve heart fail ure ( Ne w Y or k Heart Ass ociati o n Class III or 
I V), s ym pt o matic c or o nar y  arter y disease, my ocar dial i nfarcti o n, u nsta ble a n gi na 
wit hi n t he last 6 m o nt hs or k n o w n L V E F < 4 0 % (as deter mi ne d b y a M U G A sca n 
or Ec h o)

Pr ol o n ge d Q Tc F i nter val > 4 7 0 msec at scree ni n g. 

Hist or y  of sy m pt o matic ve ntric ular or s u pra ve ntr ic ular arr yt h mia (i nter mitte nt or 
per ma ne nt atrial fi brillati o n is n ot a n e xcl usi o n criteri o n), i n herite d arr h yt h mia, or 
bra d ycar dia

Hist or y  of dee p ve n o us t hr o m b osis or p ul m o nar y e m b olis m. K n o w n, ac q uire d, or 
here ditar y  t hr o m b o p hilia.
8.
Partici pa nts wit h acti ve, u nc o ntr olle d bacterial, f u n gal, or viral i nfecti o n, i ncl u di n g 
( b ut n ot li mite d t o) C O VI D-1 9/ S A R S -C o V -2, H B V, H C V, or AI D S relate d ill ness.

F or P hase 2, HI V: Partici pa nts wit h a n u n detecta ble viral l oa d a n d a C D 4 c o u nt ≥ 
4 0 0 µ L  are eli gi ble (t he y are n ot eli gi ble f or P hase 1 b).

He patitis B: T his criteri o n e xcl u des partici pa nts wit h a p ositi ve H Bs A g (ie, eit her 
ac ute or c hr o nic acti ve he patitis). Partici pa nts wit h p ositi ve a nti -H Bc A b b ut 
ne gati ve H Bs A g a n d a nti -H Bs A b pr ofile or viral D N A ne gati ve are eli gi ble.3 0

He patitis C: P ositi ve H C V A b is i n dicati ve of i nfecti o n b ut ma y  n ot necessaril y 
re n der a p ote ntial ca n di date i neli gi ble, de pe n di n g o n cli nical circ u msta nces. If 
e x p os ure t o H C V is rece nt, H C V A b ma y  n ot ha ve yet t ur ne d p ositi ve. I n t hese 
circ u msta nces test f or H C V R N A. If H C V R N A is detecte d t he partici pa nt is n ot 
eli gi ble. Refer t o C D C we bsite f or f urt her details. 3 1

C O VI D -1 9/ S A R S -C o V -2: W hile S A R S -C o V -2 testi n g is n ot ma n date d f or e ntr y  
i nt o t his st u d y, testi n g s h o ul d f oll o w l ocal cli nical practice sta n dar ds. If a 
partici pa nt has a p ositi ve test res ult f or S A R S- C o V - 2 i nfecti o n, is k n o w n t o ha ve 
as ym pt o matic i nfecti o n or is s us pecte d of ha vi n g S A R S -C o V -2, t he partici pa nt is 
e xcl u de d u ntil a ne gati ve a nti ge n test a n d res ol uti o n of s y m pt o ms if a p plic a ble.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 4
9.
Gastr oi ntesti nal a b n or malities i ncl u di n g t he i na bilit y t o ta ke oral me dicati o n, 
re q uiri n g i ntra ve n o us ali me ntati o n, or pri or s ur gical pr oce d ure or c o n diti o n affecti n g 
a bs or pti o n.
1 0. Ot her me dical or ps y c hiatric c o n diti o n i ncl u di n g rece nt ( wit hi n t he pas t year) or 
acti ve s uici dal i deati o n/ be ha vi or or la b orat or y a b n or malit y t hat ma y i ncrease t he ris k 
of st u d y  partici pati o n or, i n t he i n vesti gat or’s j u d g me nt, ma ke t he partici pa nt 
i na p pr o priate f or t he st u d y.
Pri or/ C o nc o mit a nt T her a p y:
1 1. Li ve atte n uate d vacci n es wit hi n 4 wee ks pri or t o ra n d o mizati o n a n d w hile o n trial. 
1 2. Use of c ortic oster oi ds e xce pt f or t he f oll o wi n g:

I ntra nasal, i n hale d, e ye dr o ps, t o pical ster oi ds, or l ocal ster oi d i njecti o n 
(e g, i ntraartic ular i njecti o n).

S y ste mic c ortic oster oi ds ≤1 0 m g/ da y  of pre d nis o ne or e q ui vale nt.
Pri or/ C o nc urre nt Cli nic al St u d y E x perie nce:
1 3. Partici pati o n i n ot her st u dies i n v ol vi n g st u d y i nter ve nti o n wit hi n 2 8 da ys pri or t o 
st u d y e ntr y. A partici pa nt ma y be eli gi ble e ve n if t he y are i n t he f oll o w- u p p hase of 
a n i n vesti gati o nal st u d y as l o n g as t he y ha ve n’t recei ve d i n vesti gati o nal treat me nt i n 
t he st u d y f or 2 8 d a y s.
Ot her E xcl usi o n Criteri a:
1 4. I n vesti gat or site staff directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers, site staff ot her wise s u per vise d b y t h e i n vesti gat or, a n d s p o ns or a n d s p o ns or 
dele gate e m pl o y ees directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers.
5. 3. Lifest yle C o nsi der ati o ns
5. 3. 1. C o ntr ace pti o n
T he i n vesti gat or or t heir desi g nee, i n c o ns ultati o n wit h t he partici pa nt, will c o nfir m t hat t he 
partici pa nt is usi n g a n a p pr o priate met h o d of c o ntrace pti o n f or t he i n di vi d ual partici pa nt a n d 
t heir part ner(s) fr o m t he per mitte d list of c o ntrace pti o n met h o ds (see S ecti o n 1 0. 4. 4 ) a n d will 
c o nfir m t hat t he partici pa nt has bee n i nstr uc te d i n its c o nsiste nt a n d c orre ct use. At ti me 
p oi nts i n dicate d i n t he S o A , t he i n vesti gat or or desi g nee will i nf or m t he partici pa nt of t he 
nee d t o use hi g hl y  effecti ve c o ntrace pti o n c o nsiste ntl y a n d c orrectl y a n d d oc u me nt t he 
c o n versati o n a n d t he partici pa nt’s affir mati o n i n t he partici pa nt’s c hart. Partici pa nts nee d t o 
affir m t heir c o nsiste nt a n d c orrect use of t he selecte d met h o d(s) of c o ntrace pti o n, c o nsi deri n g 
t hat t heir ris k f or pre g na nc y m a y ha ve c ha n ge d si nce t he last visit.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 5
I n a d diti o n, t he i n vesti gat or or desi g nee will i nstr uct t he partici pa nt t o call i m me diatel y if t he 
selecte d c o ntrace pti o n met h o d is disc o nti n ue d a n d d oc u me nt t he re q uire me nt t o use a n 
alter nate pr ot oc ol-s pecifie d met h o d, i ncl u di n g if t he partici pa nt will n o l o n ger use a bsti ne nce 
as t he selecte d c o ntrace pti o n met h o d, or if pre g na nc y is k n o w n or s us pecte d i n t he partici pa nt 
or part ner.
5. 3. 2. P h ot ose nsiti vi t y
P h ot ose nsiti vit y  has bee n re p orte d as a n a d verse dr u g reacti o n ( u nc o m m o n: ≥1/ 1 0 0 0 t o 
< 1/ 1 0 0) wit h le nali d o mi de. Partici pa nts will be a d vise d t o re p ort a n y reacti o n t o s u n e x p ose d 
s ki n. If a p h ot ose nsiti vit y reacti o n occ urs i n a partici pa nt, s pecial preca uti o ns s h o ul d t he n be 
ta ke n t o li mit a n y p ote ntial p h ot o irritati o n effect, b y mi ni mizi n g t he partici pa nts’ e x p os ure 
t o li g ht i ncl u di n g s u nli g ht, a n d e x p os ure t o hi g h i nte nsit y U V B li g ht s o urces s uc h as ta n ni n g 
be ds, ta n ni n g b o ot hs a n d s u nla m ps. F urt her m o re, f or p h ot ose nsiti ve partici pa nts, t hese 
i n di vi d uals s h o ul d be e nc o ura ge d t o a p ply s u nscree n/s u n bl oc k dail y a n d t o wear cl ot hi n g t hat 
c o vers areas of e x p ose d s ki n w he n o ut d o ors d uri n g da y li g ht h o urs.
5. 4. Scree n F ail ures
Scree n fail ures are defi ne d as partici pa nts w h o c o nse nt t o partici pate i n t he cli nical st u d y  b ut 
are n ot s u bse q ue ntl y e nr olle d i n t he st u d y. A mi ni mal set of scree n fail ure i nf or mati o n is 
re q uire d t o be e ntere d i nt o t he C R F t o e ns ure tra ns pare nt re p orti n g of scree n fail ure 
partici pa nts t o meet t he C O N S O R T p u blis hi n g re q uire me nts a n d t o res p o n d t o q ueries fr o m 
re g ulat or y a ut h orities. Mi ni mal i nf or mati o n i ncl u des de m o gra p h y, i nf or me d c o nse nt, 
I ncl usi o n/ E xcl usi o n, scree n fail ure details ( dis p ositi o n), a n d a n y S/ A E.
I n di vi d uals w h o d o n ot meet t he criteria f or partici pati o n i n t his st u d y (scree n fail ure) ma y be 
rescree ne d o nce. T hese partici pa nts will be pr o vi de d a ne w S SI D. Pre vi o usl y c ollecte d 
sa m ples or e xa ms ma y be utilize d if wit hi n t he re q uire me nts of t he S o A (e g, pre vi o usl y 
c ollecte d scree ni n g sa m ples were d o ne bet wee n - D 2 8 t o -D 1 or as n ote d i n S o A ). 
6. S T U D Y I N T E R V E N TI O N( S ) A N D C O N C O MI T A N T T HE R A P Y
St u d y  i nter ve nti o ns are all pres pecifie d i n vesti gati o nal a n d a u xiliar y me dici nal pr o d ucts 
( A x M P), me dical de vices, a n d ot her i nter ve nti o ns (e g, s ur gical a n d be ha vi oral) i nte n de d t o 
be a d mi nistere d t o t he st u d y partici pa nts d uri n g t he st u d y c o n d uct. F or t he p ur p oses of t his 
pr ot oc ol, st u d y  i nter ve nti o n refers t o P F-0 7 9 0 1 8 0 1, c o m bi nati o n dr u gs tafasita ma b a n d 
le nali d o mi de, a n d a u xiliar y me dici nal pr o d ucts use d f or P E T sca n a n d as pre-me dicati o ns. 
6. 1. St u d y I nter ve nti o n(s) A d mi nistere d
T a ble 4 . 
St u d y I nter ve nti o n(s) - I M P
I nter ve nti o n N a me
P F -0 7 9 0 1 8 0 1
T af asit a m a b
Le n ali d o mi de
A r m  N a me
( gr o u p of p artici p a nts 
recei vi n g a s pecific 
tre at me nt or n o 
tre at me nt)
A d mi nistere d t o all 
partici pa nts 
A d mi nistere d t o all 
partici pa nts
A d mi nistere d t o all 
partici pa nts 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 6
T a ble 4 . 
St u d y I nter ve nti o n(s) - I M P
I nter ve nti o n N a me
P F -0 7 9 0 1 8 0 1
T af asit a m a b
Le n ali d o mi de
T y pe
Bi ol o gic: C D 4 7 
tar geti n g Fc-f usi o n 
pr otei n
Bi ol o gic: C D 1 9 
tar geti n g m o n ocl o nal 
a nti b o d y
Dr u g: I Mi D
D ose F or m ul ati o n
Si n gle -use vials
Si n gle -use vials
Ca ps ules
U nit D ose Stre n gt h(s)
1 0 m g/ m L s ol uti o n f or 
i njecti o n; 1 4 m L/ vial
2 0 0 m g/ vial
2. 5 m g, 5 m g, 1 0 m g, 
1 5 m g, 2 0 m g, 2 5 m g
D os a ge Le vel(s)
Secti o n 6. 1. 1. 1
Secti o n 6. 1. 1. 2
Secti o n 6. 1. 1. 3
R o ute of 
A d mi nistr ati o n
I V i nf usi o n
I V i nf usi o n
P O
Use
E x peri me ntal
E x peri me ntal w he n 
c o m bi ne d wit h
P F -0 7 9 0 1 8 0 1 
E x peri me ntal w he n 
c o m bi ne d wit h 
P F -0 7 9 0 1 8 0 1 
I M P or NI M P/ A x M P
I M P
I M P
I M P
S o urci n g
Pr o vi de d ce ntrall y b y 
t he s p o ns or. Refer t o I P 
Ma n ual.
Pr o vi de d ce ntrall y b y 
t he s p o ns or. Refer t o I P 
Ma n ual.
Pr o vi de d ce ntrall y b y t he 
s p o ns or. Refer t o I P 
Ma n ual.
P ac k a gi n g a n d 
L a beli n g
Cart o n c o ntai ni n g 
1 vial. Eac h vial a n d 
cart o n will be o pe n 
la bele d as re q uire d b y 
eac h c o u ntr y.
A d diti o nal d osi n g 
details will be pr o vi de d 
i n t he I P Ma n ual.
Cart o n c o ntai ni n g 1 vial. 
Eac h vial a n d cart o n will 
be o pe n la bele d as 
re q uire d b y eac h 
c o u ntr y.
A d diti o nal d osi n g details 
will be pr o vi de d i n t he 
I P Ma n ual.
Will be pr o vi de d as blister 
pac ks. Eac h blister pac k 
will be o pe n la bele d as 
re q uire d b y eac h c o u ntr y.
A d diti o nal details will be 
pr o vi de d i n t he I P Ma n ual.
C urre nt/ F or mer 
N a m e(s) or Ali as(es)
P F -0 7 9 0 1 8 0 1
Tafasita ma b
Le nali d o mi de
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 7
T a ble 5 .
St u d y I nter ve nti o ns Cl assifie d as NI M Ps/ A x M Ps
I nter ve nti o n 
N a me
Fl u de o x y gl uc
ose ( 1 8F) 
( F D G)
P ar acet a m ol a
Di p he n h y dr a m i ne 
h y dr oc hl ori de a .
Ci meti di ne a .
Met h yl pre d nis ol o ne
a.
A R M N a m e
( gr o u p of 
p artici p a nts 
recei vi n g a 
s pecific 
tre atme nt) 
Ma y be 
a d mi nistere d 
t o all 
partici pa nts 
f or use wit h 
P E T sca n
Ma y be 
a d mi nistere d 
t o all 
partici pa nts as 
pre me dicati o n
a
Ma y be 
a d mi nistere d t o all 
partici pa nts as 
pre me dicati o n a
Ma y be 
a d mi nistere d t o 
all partici pa nts 
as 
pre me dicati o n a
Ma y be a d mi nistere d 
t o all partici pa nts as 
pre me dicati o n a
T y pe
Dr u g 
( dia g n ostic)
Dr u g
Dr u g
Dr u g
Dr u g 
D ose 
F or m ul ati o n
As per S m P C 
As per S m P C  
As per S m P C  
As per S m P C  
As per S m P C
U nit D ose 
Stre n gt h(s)
As per S m P C  
As per S m P C  
As per S m P C  
As per S m P C  
As per S m P C
D os a ge 
Le vel(s)
See MI NJ U VI 
S m P C a n d 
i nstit uti o nal 
g ui deli nes
See MI NJ U VI 
S m P C a n d 
i nstit uti o nal 
g ui deli nes
See MI NJ U VI 
S m P C a n d 
i nstit uti o nal 
g ui deli nes
See MI NJ U VI S m P C 
a n d i nstit uti o nal 
g ui deli nes
R o ute of 
A d mi nistr ati o n
I V i njecti o n
P O
P O or I V
P O
I V i njecti o n or 
i nf usi o n
Use
F or use wit h 
P E T
Pre me dicati o n 
Pre me dicati o n 
Pre me dicati o n 
Pre me dicati o n
I M P or 
NI M P/ A x M P
A x M P  
A x M P  
A x M P
A x M P
A x M P
S o urci n g
Site S o urce d
Site S o urce d
Site S o urce d 
Site S o urce d 
Site S o urce d
P ac k a gi n g a n d 
L a beli n g
Site S o urce d 
Site S o urce d 
Site S o urce d 
Site S o urce d
Site S o urce d 
C urre nt/ F or me
r N a me(s) or 
Ali as(es)
Per l ocal site 
s o urci n g
Per l ocal site 
s o urci n g
Per l ocal site 
s o urci n g
Per l ocal site 
s o urci n g
Per l ocal site s o urci n g
a.
Pre me dicati o ns t hat ma y be gi ve n as per MI NJ U VI S m P C [e q ui vale nt pre me dicati o n(s) i ncl u des variati o ns t o 
t he state d o nes, de pe n di n g o n t he f or m ulati o ns a vaila ble l ocall y a n d or i n acc or da nce wit h i nstit uti o nal g ui deli nes].
6. 1. 1. A d mi nistr ati o n
F or t his st u d y , a c ycle is defi ne d as 2 8 da ys, re gar dless of misse d d oses or d ose i nterr u pti o ns.
A d mi nistrati o n of P F -0 7 9 0 1 8 0 1 a n d tafasita ma b ma y be perf or me d o n a n o ut patie nt basis. 
T here is a ris k of aller gic reacti o ns, i ncl u di n g a na p h yla xis s h oc k, t h us t hese i nf usi o ns are t o 
be a d mi nistere d i n a setti n g t hat all o ws f or i m me diate access t o a n i nte nsi ve care u nit or 
e q ui vale nt e n vir o n me nt a n d a d mi nistrati o n of t hera p y  f or a na p h yla xis, s uc h as t he a bilit y t o 
i m ple me nt i m me diate res uscitati o n meas ures.
P F - 0 7 9 0 1 8 0 1 a n d tafasita ma b dr u g pr o d ucts will be dil ute d a n d a d mi nistere d as per t he I P 
Ma n ual. 
B o d y wei g ht f or d osi n g of P F -0 7 9 0 1 8 0 1 (i n part 1 b of t he st u d y ) a n d tafasita ma b ca n be 
meas ure d u p t o 7 2 h o urs pri or t o a d mi nistr ati o n o n Da y 1 of eac h c ycle. T his baseli ne wei g ht 
will be use d t o calc ulate t he s u bse q ue nt d ose(s) d uri n g t he gi ve n c y cle pr o vi de d t he wei g ht 
d oes n ot de viate m ore t ha n ± 1 0 % fr o m baseli ne d uri n g t he c o urse of t his c ycle. I n cases 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 8
w here t he partici pa nt’s b o d y  wei g ht c ha n ges m ore t ha n ± 1 0 % fr o m baseli ne, t he c urre nt 
wei g ht will be use d t o calc ulate t he ne xt a n d s u bse q ue nt d oses of dr u g. Usi n g b o d y wei g ht 
pri or t o eac h i nf usi o n is als o all o we d, if t his is t he i n vesti gat or's us ual sta n dar d of care.
Pre -i nf usi on safet y la b orat or y  test res ults m ust be re vie we d pri or t o d osi n g, per d osi n g 
sc he d ule.
Q ualifie d a n d trai ne d i n vesti gat or site pers o n nel will a d mi nister P F -0 7 9 0 1 8 0 1 a n d 
tafasita ma b t o partici pa nts b y IV i nf usi o n. D uri n g a n d f oll o wi n g eac h i nf usi o n, t he 
partici pa nts will be m o nit ore d cl osel y f or si g ns a n d s y m pt o ms of a n I R R. I n case of I RRs o r 
ot her a d verse reacti o ns, c o ns ult t he rec o m me n de d d ose m o dificati o ns pr o vi de d i n Ta ble 9 .
O n da y s i n w hic h P F-0 7 9 0 1 8 0 1 a n d tafasita ma b are a d mi nistere d o n t he sa me da y , 
P F -0 7 9 0 1 8 0 1 is a d mi nistere d first. 
6. 1. 1. 1. P F -0 7 9 0 1 8 0 1
P h ase 1 b: T he i nitial d ose le vels P F - 0 7 9 0 1 8 0 1 are as f oll o ws:
C o h ort 1 ( D L 1): 4 m g/ k g , C 1 t o C 3 Q W t he n ≥C 4 Q 2 W.
C o h ort 2 ( D L 2): 1 0 m g/ k g, C 1 t o C 3 Q W t he n ≥C 4 Q 2 W.
C o h ort 3 ( D L 3): 1 8 m g/ k g , C 1 t o C 3 Q W t he n ≥C 4 Q 2 W.
P h ase 2: if at least 2 d oses fr o m P hase 1 b are c o nsi dere d t olera ble, a p pr o xi matel y  
5 0 partici pa nts will be ra n d o mize d t o o ne of 2 selecte d fi xe d d oses base d o n P hase 1 b data. If 
o nl y  1 d ose fr o m P hase 1 b is c o nsi dere d t olera ble, a p pr o xi matel y 2 5 partici pa nts will be 
treate d at t hat o ne selecte d fi xe d d ose. 
Pre me dicati o ns are n ot re q uire d f or P F -0 7 9 0 1 8 0 1 b ut ma y  be a d mi nistere d per i nstit uti o nal 
g ui deli nes at t he i n vesti gat or’s discreti o n a n d/ or if a pri or I R R has bee n e x perie nce d. 
F or at least t he first 4 i nf usi o ns of P F -0 7 9 0 1 8 0 1, t he partici pa nt is t o re mai n i n t he cli nic f or 
o bser vati o n f or at least 1 h o ur after t he i nf usi o n (a n d t his 1 h o ur m ust c o m plete pri or t o 
starti n g t he s u bse q ue nt tafasita ma b i nf usi o n).  
6. 1. 1. 2. T af asit a m a b
Ta fasita ma b will be a d mi nistere d 1 2 m g/ k g I V wit h t he f oll o wi n g sc he d ule: 

C 1: Da y s 1, 4, 8, 1 5 a n d 2 2.

C 2 a n d C 3 ( Q W): Da ys 1, 8, 1 5 a n d 2 2.

≥C 4 ( Q 2 W): Da y s 1 a n d 1 5.
O n da y s i n w hic h P F-0 7 9 0 1 8 0 1 a n d tafasita ma b are a d mi nistere d o n t he sa me da y , 
P F - 0 7 9 0 1 8 0 1 is a d mi nistere d first. 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 9
As per MI NJ U VI (tafasita ma b) S m P C: 

A pre me dicati o n t o re d uce t he ris k of I R Rs s h o ul d be a d mi nistere d 3 0 mi n utes t o 
1 2 0 mi n utes pri or t o tafasita ma b i nf usi o n; f or partici pa nts n ot e x perie nci n g I R Rs 
d uri n g t he first 3 i nf usi o ns, pre me dicati o n is o pti o nal f or s u bse q ue nt i nf usi o ns. T he 
pre me dicati o n ma y  i ncl u de paraceta m ol/aceta mi n o p he n, di p he n h ydra mi ne, 
ci meti di ne, or met h yl pre d nis ol o ne [ or t heir res pecti ve e q ui vale nt(s)]. T he i n vesti gat or 
ma y  re peat d oses of i n di vi d ual a ge nts as re quire d a n d use ot her a ge nts, d oses a n d/ or 
f or m ulati o ns i n acc or da nce wit h i nstit uti o nal g ui deli nes. A n y pre me dicati o n gi ve n 
s h o ul d be re p orte d i n t he e C R F. 

F or t he first i nf usi o n o n C 1, t he i ntra ve n o us i nf usi o n rate s h o ul d be 7 0 m L/ h f or t he 
first 3 0 mi n utes. After war ds, t he rate s h o ul d be i ncrease d t o c o m plete t he first 
i nf usi o n wit hi n a 2. 5- h o ur peri o d. All s u bse q ue nt i nf usi o ns s h o ul d be a d mi nistere d 
wit hi n a 1. 5 t o 2-h o ur peri o d. I n case of I R Rs or ot her a d verse reacti o ns, c o ns ult t he 
rec o m me n de d d ose m o dificati o ns pr o vi de d i n Ta ble 9 . 
F or at least t he first 3 i nf usi o ns, t he partici pa nt is t o re mai n i n t he cli nic f or o bser vati o n f or at 
least 1 h o ur ( or as per i nstit uti o nal g ui deli nes) after t he tafasita ma b i nf usi o n.
6. 1. 1. 3. Le n ali d o mi de 
Le nali d o mi de will be a d mi nistere d acc or di n g t o i nstr ucti o ns i n t he c urre nt Re vli mi d S m P C. 2 0
Starti n g o n C 1 D 1, le nali d o mi de will be a d mi nistere d 2 5 m g P O dail y  o n Da ys 1 t hr o u g h 2 1 
of eac h 2 8 -d a y  c ycle f or u p t o 1 2 c ycles.
O n C 1 D 1, C 2 D 1, C 3 D 1, C 4 D 1, t he dail y  d ose of le nali d o mi de is t o be ta ke n at t he cli nic 
after t he bl o o d dra w f or le nali d o mi de P K a n d pri or t o t he P F- 0 7 9 0 1 8 0 1 I V i nf usi o n ( See 
S o A ).
Le nali d o mi de is pri maril y e xcret e d b y t he ki d ne y; partici pa nts wit h greater de grees of re nal 
i m pair me nt ca n ha ve i m paire d treat me nt t olera nce. F or partici pa nts wit h m o derate re nal 
i m pair me nt (creati ni ne cleara nce ≥3 0 m L/ mi n a n d < 6 0 m L / mi n), le nali d o mi de will be starte d 
(a n d/ or re d uce d) to 1 0 m g dail y. T he d ose ma y be escalate d t o 1 5 m g Q D after 2 c ycles if 
partici pa nt is n ot res p o n di n g t o treat me nt a n d is t olerati n g t he treat me nt.
Partici pa nts ma y  ta ke t heir oral d oses of le nali d o mi de wit h o ut re gar d t o f o o d.
F or t a ke h o me st u d y i nter ve nti o n a d mi nistr ati o n (le n ali d o mi de):
Partici pa nts m ust be i nstr ucte d t o ta ke t heir me dicati o n at a p pr o xi matel y  t he sa me ti me eac h 
da y  a n d t o n ot ta ke m ore t ha n t he prescri be d d ose at a n y ti me. 
If a partici pa nt misses a sc he d ule d d ose of st u d y i nter ve nti o n, an d it is wit hi n 1 2 h o urs of t he 
sc he d ule d d ose, t he partici pa nt s h o ul d i m me diatel y a d mi nister t he misse d d ose a n d res u me 
st u d y i nter ve nti o n i n acc or da nce wit h t he n or mal a d mi nistrati o n sc he d ule. If m ore t ha n 1 2 
h o urs ha ve ela pse d si nce t he ti me of sc he d ule d a d mi nistrati o n, t he partici pa nt s h o ul d be 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 0
i nstr ucte d n ot t o a d mi nister t he misse d d ose a n d t o res u me st u dy i nter ve nti o n as prescri be d. 
Partici pa nts s h o ul d n ot ta ke 2 d oses t o get her t o “ma ke u p ” f or a misse d d ose.
If a partici pa nt v o mits a n y ti me after taki n g a d ose, he/s he m ust be i nstr ucte d n ot t o “ ma ke it 
u p” b ut t o res u me s u bse q ue nt d oses t he ne xt da y  as prescri be d. 
If a partici pa nt i na d verte ntl y ta kes 1 e xtra d ose d uri n g a da y, t he partici pa nt s h o ul d n ot ta ke 
t he ne xt d ose of le nali d o mi de.
A d osi n g diar y  will be pr o vi de d t o t he partici pa nt t o ai d i n c o m plia nce wit h t he d osi n g 
i nstr ucti o ns.
6. 2. Pre p ar ati o n, H a n dli n g, St or a ge a n d Acc o u nt a bilit y
1.
T he i n vesti gat or or desi g nee m ust c o nfir m a p pr o priate te m perat ure c o n diti o ns (e g, 
te m perat ure) ha ve bee n mai ntai n e d d uri n g tra nsit f or all st u d y i nter ve nti o ns recei ve d 
a n d a n y discre pa ncies are re p orte d a n d res ol ve d bef ore use of t he st u d y i nter ve nti o n. 
2.
O nl y  partici pa nts e nr olle d i n t he st u d y ma y recei ve st u d y i nter ve nti o n a n d o nl y 
a ut h orize d site staff ma y  s u p pl y or a d mi nister st u d y i nter ve nti o n. 
3.
All st u d y  i nter ve nti o ns m ust be st ore d i n a sec ure, e n vir o n me ntall y c o ntr olle d, a n d 
m o nit ore d ( ma n ual or a ut o mate d rec or di n g) area i n acc or da nce wit h t he la bele d 
st ora ge c o n diti o ns wit h access li mite d t o t he i n vesti gat or an d a ut h orize d site staff. At 
a mi ni m u m, dail y mi ni m u m a n d ma xi m u m te m perat ures f or all site st ora ge l ocati o ns 
m ust be d oc u me nte d a n d a vaila ble u p o n re q uest. Data f or n o n w or ki n g da y s m ust 
i n dicate t he mi ni m u m a n d ma xi m u m te m perat ures si nce pre vi o usly d oc u me nte d f or 
all site st ora ge l ocati o ns u p o n ret ur n t o b usi ness.
4.
A n y  e xc ursi o ns fr o m t he st u d y i nter ve nti o n la bel st ora ge c o n diti o ns s h o ul d be 
re p orte d t o Pfizer u p o n disc o ver y al o n g wit h a ny acti o ns ta ke n. T he site s h o ul d 
acti vel y p urs ue o pti o ns f or ret ur ni n g t he st u d y i nter ve nti o n t o t he st ora ge c o n diti o ns 
descri be d i n t he la beli n g, as s o o n as p ossi ble. O nce a n e xc ursi o n is i de ntifie d, t he 
st u d y i nter ve nti o n m ust be q uara nti ne d a n d n ot use d u ntil Pfizer pr o vi des per missi o n 
t o use t he st u d y i nter ve nti o n. S pecific details re gar di n g t he defi niti o n of a n e xc ursi o n 
a n d i nf or mati o n t he site s h o ul d re p ort f or eac h e xc ursi o n will be pr o vi de d t o t he site 
i n t he IP Ma n ual.
5.
A n y  st ora ge c o n diti o ns state d i n t he S R S D will be s u perse de d b y t he st ora ge 
c o n diti o ns state d o n t he la bel.
6.
St u d y  i nter ve nti o ns s h o ul d be st ore d i n t heir ori gi nal c o ntai ners.
7.
Site staff will i nstr uct partici pa nts o n t he pr o per st ora ge re q uire me nts f or ta ke h o me 
st u d y i nter ve nti o n.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 1
8.
See t he I P Ma n ual f or st ora ge c o n diti o ns of t he st u d y  i nter ve nti o n o nce pre pare d f or 
a d mi nistrati o n.
9.
T he i n vesti gat or, i nstit uti o n, or t he hea d of t he me dical i nstit uti o n ( w here a p plica ble) 
or a ut h orize d site staff is res p o nsi ble f or st u d y i nter ve nti o n acc o u nta bilit y , 
rec o nciliati o n, a n d rec or d mai nte na nce (ie, recei pt, rec o nciliati o n, a n d fi nal 
dis p ositi o n rec or ds), s uc h as t he I P A L  or S p o ns or-a p pr o ve d e q ui vale nt. All st u d y 
i nter ve nti o ns will be acc o u nte d f or usi n g a st u dy i nter ve nti o n acc o u nta bilit y 
f or m/rec or d.
1 0. All st u d y  i nter ve nti o ns pr o vi de d b y t he site t hat is ta ke n h o me b y  t he partici pa nt, b ot h 
use d a n d u n use d, m ust be ret ur ne d t o t he i n vesti gat or b y  t he partici pa nt. Ret ur ne d 
st u d y i nter ve nti o n m ust n ot be re-dis pe nse d t o t he partici pa nts.
1 1. F urt her g ui da nce a n d i nf or mati o n f or t he fi nal dis p ositi o n of u n use d st u d y  
i nter ve nti o ns are pr o vi de d i n t he I P Ma n ual. All destr ucti o n m ust be a de q uatel y 
d oc u me nte d. If destr ucti o n is a ut h orize d t o ta ke place at t he i n vesti gat or site, t he 
i n vesti gat or m ust e ns ure t hat t he materials are destr o ye d i n c o m plia nce wit h 
a p plica ble e n v ir o n me ntal re g ulati o ns, i nstit uti o nal p olic y, a n d a n y s pecial i nstr ucti o ns 
pr o vi de d b y Pfizer.
U p o n i de ntificati o n of a pr o d uct c o m plai nt, n otif y t he S p o ns or wit hi n 1 b usi ness da y  of 
disc o ver y  as descri be d i n t he IP Ma n ual.
6. 2. 1. Pre p ar ati o n a n d Dis pe nsi n g
A q ua lifie d staff me m ber will dis pe nse t he ce ntrall y s o urce d st u d y i nter ve nti o n usi n g t he I R T 
s yste m via u ni q ue c o ntai ner n u m bers i n t he b ottles, vials, or blister car ds pr o vi de d, i n 
q ua ntities a p pr o priate acc or di n g t o t he S o A . Refer t o IP Ma n ual f or dis pe nsati o n of pr o d ucts. 
A sec o n d staff me m ber will verif y  t he dis pe nsi n g. T he partici pa nt/care gi ver s h o ul d be 
i nstr ucte d t o mai ntai n t he pr o d uct i n t he b ottles, or blister car ds, as a p pr o priate pr o vi de d 
t hr o u g h o ut t he c o urse of d osi n g a n d ret ur n t he b ottles, or blister car ds, as a p pr o priate t o t he 
site at t he ne xt st u d y visit.
See t he I P Ma n ual, f or i nstr ucti o ns o n h o w t o pre pare t he st u d y i nter ve nti o n f or 
a d mi nistrati o n. St u d y i nter ve nti o n s h o ul d be pre pare d a n d dis pe nse d b y  a n a p pr o priately 
q ualifie d a n d e x perie nce d me m ber of t he st u d y staff (e g, p h ys icia n, n urse, p h ysicia n’s 
assista nt, n urse practiti o ner, p har mac y  assista nt/tec h nicia n, or p har macist) as all o we d b y 
l ocal, state, a n d i nstit uti o nal g ui da nce. A sec o n d staff me m ber will verif y t he dis pe nsi n g.
F or P F -0 7 9 0 1 8 0 1 a n d tafasita ma b, vials are si n gle use.
6. 3. Assi g n me nt t o St u d y I nter ve nti o n
P hase 2 of t he st u d y will n ot be i nitiate d per b usi ness decisi o n ma de b y Pfizer ( pr ot oc ol 
a me n d me nt 2).
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 2
T he st u d y  i nter ve nti o n will be assi g ne d usi n g a n I R T s yste m. T he site will utilize t he IR T 
s yste m t o assi g n t he Dis pe nsa ble U nit or c o ntai ner n u m ber(s) pri or t o t he start of st u d y 
i nter ve nti o n a d mi nistrati o n f or eac h partici pa nt. 
T his is a n o pe n -la bel st ud y . T he i n vesti gat or’s k n o wle d ge of t he treat me nt assi g n me nt m ust 
n ot i nfl ue nce t he decisi o n t o e nr oll a partic ular partici pa nt or affect t he or der i n w hic h 
partici pa nts are e nr olle d. P ote ntial bias i n p hase 2 of t he st u d y  will be re d uce d b y t he 
f oll o wi n g ste ps: ce ntral ra n d o mizati o n.
St u d y  i nter ve nti o n will be dis pe nse d o n t he Da y 1 Visit of eac h c ycle.
T he st u d y  s pecific I R T refere nce ma n ual a n d I P Ma n ual will pr o vi de t he c o ntact i nf or mati o n 
a n d f urt her details o n t he use of t he I R T s ys te m.
6. 4. Bli n di n g
T his is a n o pe n-la bel st u d y. 
6. 5. St u d y I nter ve nti o n C o m pli a nce
W he n partici pa nts are d ose d at t he site ( P F -0 7 9 0 1 8 0 1 a n d tafasita ma b), t he y  will recei ve 
st u d y i nter ve nti o n directl y fr o m t he i n vesti gat or or desi g nee, u n der me dical s u per visi o n. T he 
date a n d ti me of e ac h d ose a d mi nistere d i n t he cli nic will be rec or de d i n t he s o urce 
d oc u me nts a n d rec or de d i n t he C R F. T he d ose of st u d y  i nter ve nti o n a n d st u d y partici pa nt 
i de ntificati o n will be c o nfir me d at t he ti me of d osi n g b y a me m ber of t he st u d y site staff 
ot her t ha n t he pers o n a d mi nisteri n g t he st u d y i nter ve nti o n. 
T he site will c o m plete t he re q uire d d osa ge Pre parati o n Rec or d l ocate d i n t he I P Ma n ual. T he 
use of t he Pre parati o n Rec or d is preferre d, b ut it d oes n ot precl u de t he use of a n e xisti n g 
a p pr o priate cli nical site d oc u me ntati o n s yste m. T he e xisti n g cli nical site’s d oc u me ntati o n 
s yste m s h o ul d ca pt ure all perti ne nt/re q uire d i nf or mati o n o n t he pre parati o n a n d 
a d mi nistrati o n of t he d ose. T his ma y be use d i n place of t he Pre parati o n Rec or d after 
a p pr o val fr o m t he s p o ns or a n d/ or desi g nee.
W he n partici pa nts self -a d mi nister st u d y le nali d o mi de at h o me, c o m plia nce wit h st u d y 
i nter ve nti o n will be assesse d at eac h visit. C o m plia nce will be assesse d by direct q uesti o ni n g, 
d osi n g diar y  (t o be mai ntai ne d w hile o n le nali d o mi de), a n d c o u nti n g ret ur ne d 
ta blets/ca ps ules d uri n g t he site visits a n d d oc u me nte d i n t he s o urce d oc u me nts a n d C R F. 
Partici pa nts will be re q uire d t o ret ur n t he c o m plete d patie nt d osi n g diar y  f or le nali d o mi de o n 
D a y  1 of e ver y c ycle t hr o u g h C ycle 1 2 or E O T f or ti mel y re vie w by site pers o n nel a n d 
disc ussi o n of misse d d oses a n d/ or c o m plia nce iss ues t o e ns ure acc urate data e ntr y  f or t he 
D osi n g C R F.
A rec or d of t he n u m ber of P F - 0 7 9 0 1 8 0 1 vials, tafasita ma b vials, a n d le nali d o mi de ca ps ules 
dis pe nse d t o a n d ta ke n b y ea c h partici pa nt m ust be mai ntai ne d a n d rec o ncile d wit h st u d y  
i nter ve nti o n a n d c o m plia nce rec or ds. I nter ve nti o n start a n d st o p dates, i ncl u di n g dates f or 
i nter ve nti o n i nterr u pti o ns a n d/ or d ose re d ucti o ns, will als o be rec or de d i n t he C R F.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 3
6. 6. D ose M o dific ati o n 
Criteria f or d ose m o dificati o n d ue t o t o xicit y  a n d efficac y are prese nte d i n t he f oll o wi n g 
secti o ns. P F-0 7 9 0 1 8 0 1 d ose escalati o n/ de -escalati o n is descri be d i n Secti o n 4. 3. 3 .
E ver y  eff ort s h o ul d be ma de t o a d mi nister st u d y i nter ve nti o n o n t he pla n ne d d ose a n d 
sc he d ule. I n t he e ve nt of si g nifica nt t o xicit y, d osi n g of P F-0 7 9 0 1 8 0 1 a n d tafasita ma b ma y  be 
m o difie d as descri be d bel o w. In t he e ve nt of m ulti ple t o xicities, d ose m o dificati o n s h o ul d be 
base d o n t he w orst t o xicit y  o bser ve d a n d attri b uti o n f or t he c o m bi nati o n treat me nt. 
D osi n g m o dificati o ns s h o ul d be assi g ne d t o eac h pr o d uct base d o n attri b uti o n t o eac h 
co m p o ne nt (ie, w he n c o m p o u n d A a n d B are c o m bi ne d a n d t o xicit y  occ urs a n d is attri b ute d 
t o c o m p o u n d A, a d ose m o dificati o n of c o m p o u n d A ma y be a p plica ble b ut n ot necessarily t o 
c o m p o u n d B). W he n t o xicit y ma y be attri b ute d t o all c o m p o u n ds (e g, ne utr o pe nia a n d 
t hr o m b oc yt o pe nia), all t hera pies will be i nterr u pte d a n d u p o n rec o ver y o nly le nali d o mi de 
will be re -starte d at a l o wer d ose.
Partici pa nts are t o be i nstr ucte d t o n otif y  i n vesti gat ors at t he first occ urre nce of a n y a d verse 
s ym pt o m. I n a d diti o n t o d ose m o dificati o ns, i n vesti gat ors are e nc o ura ge d t o e m pl o y  best 
s u p p orti ve care acc or di n g t o l ocal i nstit uti o nal cli nical practices.
6. 6. 1. D ose -M o dific ati o n G ui deli nes
All d ose m o dificati o ns s h o ul d be base d o n t he w orst prece di n g t o xicit y  a n d m ust be rec or de d 
o n t he C R F. D ose m o dificati o ns f or tafasita ma b are f urt her descri be d i n MI NJ U VI  
(tafasita ma b) S m P C; f or d ose m o dificati o ns re gar di n g le nali d o mi de c o ns ult t he Re vli mi d ® 
S m P C. 2 0 ,2 2
Ta ble 6 t hr o u g h Ta ble 9 pr o vi de d ose m o dificati o ns i n case of he mat ol o gic a n d 
n o n -he mat ol o gic t o xicities. Per mitte d d ose re d ucti o ns f or le nali d o mi de are o utli ne d i n 
Ta ble 1 0 . W he n d osi n g is wit h hel d base d o n t he f oll o wi n g criteria o utli ne d bel o w, cli nical 
a n d la b orat or y re- e val uati o n s h o ul d be re peate d at least wee kl y or m ore fre q ue ntl y  per 
i nstit uti o nal g ui deli nes u ntil t he t o xicit y res ol ves as per t o xicit y rec o m me n dati o n; see als o 
A p pe n di x 6 ( H y's la w). I n e ve nts w here t here are tra nsie nt la b val ue a b n or malities t hat, base d 
o n i n vesti gat or assess me nt, are n ot cli nicall y si g nifica nt or are relate d t o disease a n d n ot t he 
dr u g, c o nti n uati o n of t hera p y  wit h o ut f oll o wi n g t he d ose-m o dificati o n g ui deli nes is 
per missi ble.
N o s pecific d ose a dj ust me nts are rec o m me n de d f or gra de 1 or 2 t reat me nt-relate d t o xicit y. 
H o we ver, i n vesti gat ors s h o ul d al wa y s ma na ge t heir partici pa nts acc or di n g t o t heir me dical 
j u d g me nt base d o n t he partic ular cli nical circ u msta nces.
O nce a le nali d o mi de d ose has bee n re d uce d f or a gi ve n partici pa nt, all s u bse q ue nt c ycles will 
be a d mi nistere d at t hat d ose le vel, u nless f urt her d ose re d ucti o n is re q uire d. I ntra partici pa nt 
d ose re -escalati o n is n ot all o we d.
Partici pa nts i n P hase 1 b e x perie nci n g a D L T ma y re d uce P F - 0 7 9 0 1 8 0 1 d osi n g a n d res u me at 
t he ne xt l o wer d ose le vel (if a p plica ble) o nce a de q uate rec o ver y is ac hie ve d, a n d i n t he 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 4
o pi ni o n of t he i n vesti gat or a n d s p o ns or, t he partici pa nt is be nefiti n g fr o m t hera p y. I n P hase 2 , 
P F -0 7 9 0 1 8 0 1 t o xicities are ma na ge d o nl y wit h d ose i nterr u pti o n ( n ot re d ucti o n, u nless
e x pressl y a gree d ot her wise f oll o wi n g disc ussi o n bet wee n t he i n vesti gat or a n d t he s p o ns or ).
A p pr o priate f oll o w- u p assess me nts m ust be d o ne u ntil a de q uate rec o ver y  occ urs as assesse d 
b y  t he i n vesti gat or. Criteria re q uire d bef ore treat me nt ca n res u me are descri be d i n
Secti o n 6. 6. 2 .
If t he A E t hat le d t o t he treat me nt i nterr u pti o n rec o vers wit hi n t he sa me c ycle, t he n re-d osi n g 
i n t hat c ycle is al l o we d. D oses o mitte d f or t o xicit y are n ot re place d wit hi n t he sa me c ycle. 
T he nee d f or a le nali d o mi de d ose re d ucti o n at t he ti me of treat me nt res u m pti o n s h o ul d be 
base d o n t he criteria defi ne d i n t he ta bles bel o w, u nless e x pressl y  a gree d ot her wise f oll o wi ng 
disc ussi o n bet wee n t he i n vesti gat or a n d t he s p o ns or. If a d ose re d ucti o n of le nali d o mi de is 
a p plie d i n t he sa me c ycle, t he partici pa nt will nee d t o ret ur n t o t he cli nic t o recei ve ne w dr u g 
s u p pl y.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 5
T a ble 6 .
D ose M o dific ati o ns f or Rel ate d He m at ol o gic T o xicities
Criteri a
Se verit y
D os a ge m o dific ati o n
Ne utr o pe nia
A N C < 1 0 0 0/ µl f or at least 7 da ys
or
A N C < 5 0 0/ µl
or
A N C < 1 0 0 0/ µl w it h a si n gle 
t e mperat ure of > 3 8. 3 ° C or a s ustai ne d 
t e mperat ure of ≥3 8 ° C f or m ore t ha n 
o ne h o ur
G 3/ 4
Wit h h ol d P F -0 7 9 0 1 8 0 1, tafasita ma b a n d le nali d o mi de a n d m o nit or C B C at least 
wee kl y u ntil A N C is ≥1 0 0 0/ µl, t he n:

Res u me P F -0 7 9 0 1 8 0 1 a n d tafasita ma b at t he sa me d ose;

Re d uce le nali d o mi de b y o ne d ose le vel:
o
See Secti o n 6. 9. 4 re gar di n g use of he mat o p oietic gr o wt h fact ors. 
o
Re peat as a b o ve f or a s u bse q ue nt e ve nt. After sec o n d d ose re d ucti o n of 
le nali d o mi de a n d a s u bse q ue nt e ve nt, disc uss wit h s p o ns or f or f urt her d ose 
m o dificati o n o pti o ns. 
T hr o m b oc yt o pe nia
G 3/ 4
Wit h h ol d P F -0 7 9 0 1 8 0 1, tafasita ma b a n d le nali d o mi de a n d m o nit or C B C at least 
wee kl y u ntil platelet c o u nt is ≥5 0 0 0 0/ µl or baseli ne, t he n:

Res u me P F -0 7 9 0 1 8 0 1 a n d tafasita ma b at t he sa me d ose;

Re d uce le nali d o mi de b y o ne d ose le vel:
o
Re peat as a b o ve f or a s u bse q ue nt e ve nt. After sec o n d d ose re d ucti o n of 
le nali d o mi de a n d a su bse q ue nt e ve nt, disc uss wit h s p o ns or f or f urt her d ose 
m o dificati o n o pti o ns. 
T hr o m b oc yt o pe nia ≥G 3 wit h ≥G 2 
blee di n g 
≥G 3
Wit h h ol d P F -0 7 9 0 1 8 0 1, tafasita ma b a n d le nali d o mi de a n d m o nit or C B C at least 
wee kl y u ntil platelet c o u nt is ≥5 0 0 0 0/ µl or baseli ne a n d blee di n g has st o p pe d, t he n:

Res u me P F -0 7 9 0 1 8 0 1 a n d tafasita ma b at t he sa me d ose;

Re d uce le nali d o mi de b y o ne d ose le vel:
o
Re peat as a b o ve f or a s u bse q ue nt e ve nt. After sec o n d d ose re d ucti o n of 
le nali d o mi de a n d a s u bse q ue nt e ve nt, disc uss wit h s p o ns or f or f urt her d ose 
m o dificati o n o pti o ns.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 6
T a ble 6 .
D ose M o dific ati o ns f or Rel ate d He m at ol o gic T o xicities
Criteri a
Se verit y
D os a ge m o dific ati o n
A ne mia 
G 3/ 4
Wit h h ol d P F -0 7 9 0 1 8 0 1, tafasita ma b a n d le nali d o mi de a n d m o nit or C B C at least 
wee kl y u ntil he m o gl o bi n is ≥8 g/ d L, t he n:

Res u me P F -0 7 9 0 1 8 0 1 a n d tafasita ma b at t he sa me d ose;

Re d uce le nali d o mi de b y o ne d ose le vel:
o
See Secti o n 6. 9. 4 re gar di n g use of he mat o p oietic gr o wt h fact ors. 
o
Re peat as a b o ve f or a s u bse q ue nt e ve nt. After sec o n d d ose re d ucti o n of 
le nali d o mi de a n d a s u bse q ue nt e ve nt, disc uss wit h s p o ns or f or f urt her d ose 
m o dificati o n o pti o ns.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 7
T a ble 7 .
D ose M o dific ati o ns f or N o n - He m at ol o gic T o xicities
Criteri a
Se verit y
D os a ge m o dific ati o n
N o n -he mat ol o gic la b orat or y 
e ve nts c o nsi dere d relate d t o 
st u d y treat me nt(s) 
≥G 3

H ol d s us pecte d t hera p y(ies) u ntil res ol uti o n t o ≤G 2 or baseli ne or t o a le vel deter mi ne d t o be 
acce pta ble b y t he i n vesti gat or.

Le nali d o mi de ma y be re d uce d b y o ne d ose le vel. Se e als o S m P Cs f or MI NJ U VI (tafasita ma b) 
a n d R E V LI MI D (le nali d o mi de).

Tra nsie nt, as y m pt o matic, G 4 la b orat or y a b n or malities c o nsi dere d n ot cli nicall y si g nifica nt ma y 
n ot re q uire a d ose re d ucti o n f oll o w i n g a gree me nt bet wee n i n vesti gat or a n d t he s p o ns or.
A b n or m al li ver tests (relate d 
or u nrelate d)
≥G 2

Partici pa nts w h o prese nt wit h ele vate d A S T/ A L T a n d bilir u bi n m ust be e val uate d f urt her as 
p ote ntial DI LI ( H y’s la w) cases t o defi niti vel y deter mi ne t he eti ol o g y of t he a b n or mal la b orat or y 
val ues; e val uati o n i s t o occ ur as s o o n as p ossi ble, prefera bl y wit hi n 4 8 h o urs of t he a b n or mal 
res ults. See Li ver Safet y G ui deli nes f or f oll o w-u p of p ossi ble DI LI ( A p pe n di x 6 ).
A b n or m al li ver tests (relate d 
or u nrelate d)
≥G 3

H ol d s us pect e d t hera p y(ies) u ntil res ol uti o n t o ≤G 2 or baseli ne or t o a le vel deter mi ne d t o be 
acce pta ble b y t he i n vesti gat or.

Le nali d o mi de ma y be re d uce d b y o ne d ose le vel. See als o S m P Cs f or MI NJ U VI (tafasita ma b) 
a n d R E V LI MI D (le nali d o mi de).

Partici pa nts w h o prese nt wit h ele vate d A S T/ A L T a n d bilir u bi n m ust be e val uate d f urt her as 
p ote ntial DI LI ( H y’s la w) cases t o defi niti vel y deter mi ne t he eti ol o g y of t he a b n or mal la b orat or y 
val ues; e val uati o n is t o occ ur as s o o n as p ossi ble, prefera bl y w it hi n 4 8 h o urs of t he a b n or mal 
res ults. See Li ver Safet y G ui deli nes f or f oll o w-u p of p ossi ble DI LI ( A p pe n di x 6 ).
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 8
T a ble 7 .
D ose M o dific ati o ns f or N o n - He m at ol o gic T o xicities
Criteri a
Se verit y
D os a ge m o dific ati o n
Ot her N o n -he mat ol o gic A Es 
(relate d)
G 3

H ol d s us pecte d t hera p y(ies) u ntil res ol uti o n t o ≤G 1 or baseli ne or t o a le vel deter mi ne d t o b e 
acce pta ble b y t he i n vesti gat or. 

Le nali d o mi de ma y be re d uce d b y o ne d ose le vel. See als o S m P Cs f or MI NJ U VI (tafasita ma b) 
a n d R E V LI MI D (le nali d o mi de).
E xce pti o ns ( d o n ot re q uire d ose m o dificati o ns, ma na ge s y m pt o ms as per i nstit uti o nal sta n dar d of 
care):
o
G 3 na usea, v o miti n g, a n d diarr hea res ol ve d t o ≤G 1 or baseli ne wit hi n 4 8 h o urs wit h 
s u p p orti ve care;
o
Tra nsie nt G 3 fati g ue (lasti n g < 7 2 h o urs).
Ot her N o n -he mat ol o gic A Es 
(relate d) 
G 4

C o nsi der per ma ne ntl y disc o nti n ui n g t he s us pecte d t hera p y(ies). I n t he case w here t he 
i n vesti gat or deter mi nes t he partici pa nt is o btai ni n g a cli nical be nefit, disc uss wit h s p o ns or f or 
f urt her d ose m o dificati o n o pti o ns.

H ol d s us pect t hera p y(ies) u ntil res ol uti o n t o ≤G 1 or baseli ne or t o a le vel deter mi ne d t o be 
acce pta ble b y t he i n vesti gat or. W he n res u me d after i nterr u pti o n, le nali d o mi de is t o be re d uce d 
b y o ne d ose le vel. See als o S m P Cs f or MI NJ U VI (tafasita ma b) a n d R E V LI MI D (le nali d o mi de).
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 9
T a ble 8 .
D ose M o dific ati o ns f or Le n ali d o mi de T o xicities
Criteri a 
Se verit y
D os a ge m o dific ati o n
T hr o m b oe m b olic e ve nts 
(relate d)
G 3/ 4

I nterr u pt le nali d o mi de d osi n g. Start a ntic oa g ulati o n as 
per l ocal g ui deli nes.

C o nti n ue ot her st u d y i nter ve nti o ns after disc ussi o n 
wit h t he s p o ns or. 
T o xicities res ol ve 
t o ≤G 2

Restart le nali d o mi de at i n vesti gat or’s discreti o n 
Aller gic reacti o n or 
h y perse nsiti vit y (relate d)
> G 2

I nterr u pt le nali d o mi de d osi n g. F oll o w at least e ver y 
7 da ys.

C o nti n ue ot her st u d y i nter ve nti o ns as per pr ot oc ol.
T o xicities res ol ve 
t o ≤G 2

Restart le nali d o mi de at ne xt l o wer d ose le vel.
Aller gic reacti o n or 
h y perse nsiti vit y 
(i ncl u di n g b ut n ot 
li mite d t o SJ S, T E N, 
e xf oliati ve or b ull o us 
ras h, a n gi oe de ma) 
(relate d)
G 3/ 4

Disc o nti n ue le nali d o mi de per ma ne ntl y.

C o nti n ue ot her st u d y i nter ve nti o ns after disc ussi o n 
wit h t he s p o ns or. 
Des q ua mati n g 
( blisteri n g) ras h ≥G 3 or 
n o n- des q ua mati n g ras h 
G 4 c o nsi dere d t o be 
relate d t o le nali d o mi de

Disc o nti n ue le nali d o mi de per ma ne ntl y. 

C o nti n ue ot her st u d y i nter ve nti o ns after disc ussi o n 
wit h t he s p o ns or.
N o n -des q ua mati n g ras h 
(relate d)
G 3/ 4

I nterr u pt le nali d o mi de d osi n g.

C o nti n ue ot her st u d y i nter ve nti o ns after disc ussi o n 
wit h t he s p o ns or. 
T o xicities res ol ve 
t o ≤G 1

Restart le nali d o mi de at ne xt l o wer d ose le vel.
T u m or flare reacti o n 
(relate d)
G 1/ 2

Pr o vi de s y m pt o matic treat me nt as per l ocal g ui deli nes .

C o nti n ue le nali d o mi de wit h o ut d ose m o dificati o ns or 
i nterr u pt as per i n vesti gat or’s discreti o n. 

C o nti n ue ot her st u d y i nter ve nti o ns as per pr ot oc ol. 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 0
T a ble 8 .
D ose M o dific ati o ns f or Le n ali d o mi de T o xicities
Criteri a 
Se verit y
D os a ge m o dific ati o n
T u m or flare reacti o n
(relate d)
G 3/ 4

I nterr u pt le nali d o mi de d osi n g.

Pr o vi de s y m pt o matic treat me nt as per l ocal g ui deli nes. 

C o nti n ue ot her st u d y i nter ve nti o ns after disc ussi o n 
wit h t he s p o ns or. 
T o xicities res ol ve 
t o ≤G 1

Restart le nali d o mi de ( mai ntai n sa me d ose le vel).
Ki d ne y t o xicities as per 
C T C A E v 5. 0 (test ca n be 
re peate d after pr o per 
h y drati o n, if nee de d)
(relate d or u nrelate d)
G 2

R e d uce le nali d o mi de t o 1 0 m g o nce dail y.
G 3 n ot re q uiri n g 
dial ysis

A d mi nister le nali d o mi de at 1 5 m g e ver y ot her da y.

Disc o nti n ue le nali d o mi de if dial ysis is re q uire d.
G 4

Disc o nti n ue le nali d o mi de.
T a ble 9 .
D ose M o dific ati o ns f or I nf usi o n -Rel ate d Re acti o ns
Se verit y
D os a ge m o dific ati o n f or P F -0 7 9 0 1 8 0 1 or t af asit a m a b
G 1 t o 3

If a partici pa nt has e x perie nce d a G 1 t o G 3 I R R, pre me dicati o n ma y be a d mi nistere d bef ore 
s u bse q ue nt i nf usi o ns wit h t he st u d y i nter ve nti o n t hat has ca use d t he I R R (as per 
i n vesti gat or discreti o n a n d i nstit uti o nal g ui da nce).
G 2

I nterr u pt i nf usi o n i m me diatel y a n d ma na ge si g ns a n d s y m pt o ms as per i nstit uti o nal 
g ui deli nes wit h a n a nti hista mi ne a n d/ or aceta mi n o p he n ( paraceta m ol). If cli nicall y 
i n dicate d, a gl uc oc ortic oi d ca n be use d.

O nce si g ns a n d s y m pt o ms res ol ve or re d uce t o G 1, res u me i nf usi o n at n o m ore t ha n 5 0 % of 
t he rate at w hic h t he reacti o n occ urre d. If t he partici pa nt d oes n ot e x perie nce f urt her 
reacti o n wit hi n 1 h o ur a n d vital si g ns are sta ble, t he i nf usi o n rate ma y be i ncrease d e ver y 
3 0 mi n utes as t olerate d t o t he rate at w hic h t he reacti o n occ urre d.
G 3

I nterr u pt i nf usi o n i m me diately a n d ma na ge si g ns a n d s y m pt o ms. T he partici pa nt is t o 
recei ve a p pr o priate treat me nt as per i nstit uti o nal g ui deli nes wit h a n a nti hista mi ne a n d/ or 
aceta mi n o p he n ( paraceta m ol) or a gl uc oc ortic oi d a n d, if necessar y, f urt her me dicati o ns (ie, 
e pi ne p hri ne, br o n c h o dilat or).

O nce si g ns a n d s y m pt o ms res ol ve or re d uce t o G 1, res u me i nf usi o n at n o m ore t ha n 2 5 % of 
t he rate at w hic h t he reacti o n occ urre d. If t he partici pa nt d oes n ot e x perie nce f urt her 
reacti o n wit hi n 1 h o ur a n d vital si g ns are sta ble, t he i nf usi o n rate ma y be i ncrease d e ver y 
3 0 mi n utes as t olerate d t o a ma xi m u m of 5 0 % of t he rate at w hic h t he reacti o n occ urre d.

If after rec halle n ge t he reacti o n ret ur ns, st o p t he i nf usi o n i m me diatel y.

If si g ns a n d s y m pt o ms d o n ot re d uce t o G 1, st o p t he c urre nt i nf usio n. T he i n vesti gat or a n d 
S p o ns or’s me dical m o nit or will deci de w het her t o c o nti n ue treati n g partici pa nts w h o 
e x perie nce d a G 3 I R R o n a case -b y -case basis. 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 1
T a ble 9 .
D ose M o dific ati o ns f or I nf usi o n -Rel ate d Re acti o ns
Se verit y
D os a ge m o dific ati o n f or P F -0 7 9 0 1 8 0 1 or t af asit a m a b

As wit h all p ote ntial ris ks, t he me dical m o nit or s h o ul d be a p prise d of a n y ≥G 3 I R R t hat 
occ urs d uri n g t he st u d y.
G 4
St o p t he i nf usi o n i m me diatel y a n d per ma ne ntl y disc o nti n ue tafasita ma b a n d/ or P F -0 7 9 0 1 8 0 1. 
T he partici pa nt m ust recei ve a p pr o priate treat me nt wit h a n a nti hista mi ne a n d/ or aceta mi n o p he n 
( paraceta m ol) or a gl uc oc ortic oi d   a n d, if necessar y, f urt her me dicati o ns (ie, e pi ne p hri ne, 
br o nc h o dilat or).
T a ble 1 0 . Re d ucti o ns f or Le n ali d o mi de
Starti n g d ose 
2 5 m g 
D L 1
2 0 m g
D L 2
1 5 m g
D L 3 (starti n g d ose f or m o derate re nal i m pair me nt)
1 0 m g
D L 4
5 m g
D L 5 a
2. 5 m g 
a.
Patie nts w h o ca n n ot t olerate D L 5 are t o be disc o nti n ue d fr o m le nali d o mi de treat me nt i n t he st u d y b ut s h o ul d 
c o nti n ue P F -0 7 9 0 1 8 0 1 a n d tafasita ma b.
6. 6. 2. Re -Tre at me nt After T o xicit y 
Re -treat me nt f oll o wi n g treat me nt i nterr u pti o n f or treat me nt-relate d t o xicit y or at t he start of 
a n y ne w c ycle ma y n ot occ ur u ntil all of t he f oll o wi n g para meters ha ve bee n met:

A N C ≥1 0 0 0/ µ L ;

Platelet c o u nt ≥5 0 0 0 0/ µ L ;

He m o gl o bi n is ≥8 g/ d L ;

Rec o ver y  of treat me nt-relate d n o n-la b orat or y t o xicities t o baseli ne or ≤G 1 se verit y.

Rec o ver y of treat me nt -relate d n o n-he mat ol o gic la b orat or y  t o xicities t o baseli ne or 
≤G 2 se verit y.
If a treat me nt i nterr u pti o n res ults fr o m w orse ni n g of he mat ol o gic or bi oc he mical para meters, 
t he fre q ue nc y of rele va nt bl o o d tests is t o be i ncrease d as cli nicall y i n dicate d.
6. 7. C o nti n ue d Access t o St u d y I nter ve nti o n After t he E n d of t he St u d y
N o i nter ve nti o n will be pr o vi de d per pr ot oc ol t o st u d y  partici pa nts be yo n d t he e n d of t he 
st u d y. A vaila bilit y of P F-0 7 9 0 1 8 0 1 f oll o wi n g cl os ure of t he st u d y (t hr o u g h e x pa n de d 
access/c o m passi o nate/c o nti n ue d use mec ha nis m, if t he i n vesti gat or a n d partici pa nt desire t o 
c o nti n ue treat me nt) w o ul d be at t he discreti o n of t he s p o ns or a n d s u bject t o l ocal c o n diti o ns 
a n d re g ulati o ns. 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 2
6. 8. Tre at me nt of O ver d ose
T here is n o s pecific treat me nt f or a n o ver d ose of P F -0 7 9 0 1 8 0 1. T he I n vesti gat or m ust ta ke 
s ym pt o m -directe d acti o ns wit h re gar d t o s u p p orti ve meas ures. A n o ver d ose f or t his st u d y  is 
defi ne d as e xcee di n g t he pla n ne d d ose b y m ore t ha n 2 0 %.
I n t he e ve nt of a n o ver d ose, t he i n vesti gat or s h o ul d:
1.
C o ntact t he st u d y  me dical m o nit or wit hi n 2 4 h o urs.
2.
Cl osel y  m o nit or t he partici pa nt f or a ny A Es/ S A Es a n d la b orat or y  a b n or malities as 
me dicall y  a p pr o priate a n d at least u ntil t he ne xt sc he d ule d f oll o w- u p.
3.
D oc u me nt t he q ua ntit y of t he e xcess d ose as well as t he d urati o n of t he o ver d ose i n 
t he C R F (i n t he d osi n g pa ges a n d as me dicati o n err or).
4.
O ver d ose is re p orta ble t o Pfizer Safet y  o nly w he n ass ociate d wit h a n S A E.
Refer t o t he prescri bi n g i nf or mati o n f or o ver d ose g ui da nce f or tafasita ma b a n d le nali d o mi de.
6. 9. Pri or a n d C o nc o mit a nt T her a p y
H or m o nal c o ntrace pti ves t hat meet t he re q uire me nts of t his st u d y  are all o we d t o be use d i n 
partici pa nts w h o are W O C B P (see A p pe n di x 4 ).
C o nc o mita nt treat me nt c o nsi dere d necessar y  f or t he partici pa nt’s well-bei n g ma y  be gi ve n at 
discreti o n of t he treati n g p h y sicia n.
See Secti o n 6. 9. 4 re gar di n g li mitati o ns o n pr o p h ylactic use of c ol o n y sti m ulati n g fact ors or 
er yt hr o p oiesis -sti m ulati n g a ge nts d uri n g t he D L T peri o d.
All c o nc o mita nt treat me nts, bl o o d pr o d ucts, as well as n o n dr u g i nter ve nti o ns recei ve d b y  
partici pa nts fr o m scree ni n g u ntil t he E O T visit will be rec or de d o n t he C R F.
6. 9. 1. Pr o hi bite d I n hi bit ors/I n d ucers
6. 9. 1. 1. P F -0 7 9 0 1 8 0 1
P F - 0 7 9 0 1 8 0 1 is eli mi nate d via n o n-s pecific Fc R n-me diate d pr ote ol yt ic de gra dati o n a n d 
tar get me diate d cleara nce; t heref ore, ot her c o nc o mita nt me dicati o ns are u nli kel y t o alter t he 
P K of P F - 0 7 9 0 1 8 0 1. 
6. 9. 1. 2. T af asit a m a b
I n vesti gat ors s h o ul d c o ns ult t he E U S m P C f or tafasita ma b f or i nf or mati o n re gar di n g 
me dicati o n t hat is pr o hi bite d f or c o nc o mita nt use d uri n g t he st u d y.
6. 9. 1. 3. Le n ali d o mi de
I n vesti gat ors s h o ul d c o ns ult t he E U S m P C f or le nali d o mi de f or i nf or mati o n re gar di n g 
me dicati o n t hat is pr o hi bite d f or c o nc o mita nt use d ur i n g t he st u dy.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 3
6. 9. 2. Ot her Pr o hi bite d a n d/ o r Li mite d Use of A nti -T u m or/ A nt i-C a ncer or 
E x peri me nt al Dr u gs or Pr oce d ures 
N o a d diti o nal a ntica ncer t hera p y will be per mitte d w hile partici pa nts are recei vi n g st u d y 
i nter ve nti o n a n d pri or t o d oc u me nte d pr o gressi o n.
6. 9. 3. S u p p orti ve C are
Palliati ve a n d s u p p orti ve care f or disease relate d s y m pt o ms ma y  be a d mi nistere d at t he 
i n vesti gat or’s discreti o n a n d acc or di n g t o t he s pecific s u p p orti ve care pr o d uct Prescri bi n g 
I nf or mati o n or t he c urre nt A S C O g ui deli nes. 
T L S res ults fr o m t he ra pi d brea k d o w n of t u m or cells a n d t he release of t heir i ntracell ular 
c o nte nt i nt o t he bl o o dstrea m. T he release of lar ge a m o u nts of p otassi u m, p h os p h or us, a n d 
n ucleic aci ds o ver w hel ms n or mal h o me ostatic mec ha nis ms, res ulti n g i n h y per kale mia, 
h y per p h os p hate mia, h y p er urice mia, a n d sec o n dar y h y p ocalce mia. Ele vate d L D H a n d 
ele vate d A S T are p ote ntial i n dicat ors f or T L S. T he o nset of T L S is ra pi d, us uall y  wit hi n 
2 4 t o 4 8 h o urs of recei pt of t he first d ose of a ntica ncer me dicati o n, b ut ca n als o occ ur after 
t he first wee k of treat me nt. Left u ntreate d, T LS ca n lea d t o ac ute re nal fail ure, car diac 
d y sr hyt h mia, ne ur ol o gic c o m plicati o ns, a n d seiz ures. B ul k y  disease, m o derate re nal 
i ns ufficie nc y, a hi g h n u m ber of circ ulati n g l ym p h o ma cells a n d hi g h uric aci d le vels 
( > 8 m g / d L) pri or t o t hera p y, i ncrease t he li keli h o o d of T LS. I n patie nts wit h hi g h ris k of T L S 
(e g, patie nts wit h lar ge t u m or b ur de n, ele vate d L D H, or hi g h pr oliferati o n rate of t u m or 
cells), T LS pr o p h y la xis is t o be c o nsi dere d. All a p pr oac hes t o miti gate t he ris k of de vel o pi n g 
T L S, s uc h as a de q uate h y drati o n or h y p o urice mic a ge nts (e g, all o p uri n ol or ras b uricase), 
ma y  be use d i n hi g h ris k patie nts as per i nstit uti o nal g ui deli nes (see als o R E V LI MI D S m P C). 
Patie nts s h o ul d be m o nit ore d cl osel y f or T L S d uri n g treat me nt wit h tafasita ma b a n d 
le nali d o mi de.
C y t o ki ne release sy n dr o me is n ot a n e x pecte d ris k wit h t he c o m bi nati o n t hera pies of t his 
st u d y. If s us pecte d, sy m pt o ms a n d se verit y  of C R S will be assesse d acc or di n g t o t he A S T C T 
criteria descri be d b y Lee et al. 2 8 F or C R S ma na ge me nt, p u blis he d treat me nt g ui deli nes are 
rec o m me n de d, b ut t he y ma y be m o difie d as nee de d b y t he res p o nsi ble i n vesti gat or acc or di ng 
t o t he best practices at t heir i nstit ute.3 2 ,3 3
I nf usi o n relate d reacti o n is c haracterize d by fe ver a n d c hills, a n d less c o m m o nl y  
h y p ote nsi o n, eit her e x perie nce d b y  a partic ular partici pa nt or if see n i n ot her partici pa nts, 
pretreat me nt me dicati o n s h o ul d be a d mi nistere d t o re d uce t he i nci de nce a n d se verit y. I n t he 
e ve nt of i nf usi o n relate d reacti o ns, I n vesti gat ors s h o ul d i nstit ute treat me nt meas ures 
acc or di n g t o best me dical a n d n ursi n g practice. A s u g geste d treat me nt al g orit h m f or t he 
ma na ge me nt of I RR is p r o vi de d i n t he Ta ble 9 ; h o we ver, if l ocal sta n dar d of care is a 
differe nt re gi me n t his s h o ul d be utilize d.
T y pe 1 h y perse nsiti vit y  or aller gic (e g, s hort ness of breat h, urticaria, a na p h y la xis, 
a n gi oe de ma) reacti o ns are t he oreticall y  p ossi ble i n res p o nse t o a n y i njecte d pr otei n. Im m u ne 
c o m ple x me diate d T ype 3 h y perse nsiti vit y  reacti o ns are si milar t o t he A Es of T yp e 1 
reacti o ns b ut are li kely t o be dela y e d fr o m t he ti me of i nf usi o n a n d ma y  i ncl u de s ym pt o ms 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 4
s uc h as ras h, urticaria, p ol yart hritis, m yal gia, p ol ys y n o vitis, fe ver, a n d, if se vere, 
gl o mer ul o ne p hritis.
All partici pa nts s h o ul d be cl osel y o bser ve d w hile recei vi n g st u d y i nter ve nti o n i nf usi o ns a n d 
m o nit ori n g f or cli nical si g ns of a s ys te mic reacti o n will c o nti n ue t hereafter f or cli nical si g ns 
of aller gic reacti o ns/ h y perse nsiti vit y . 
I n t he case of a hy p erse nsiti vit y reacti o n, t he partici pa nt will be treate d sy m pt o maticall y  wit h 
s u p p orti ve care, f urt her m o nit ori n g, a n d treat me nt wit h a nti-hista mi nes a n d/ or 
c ortic oster oi ds. St u d y i nf usi o ns ma y be st o p pe d a n d t he partici pa nt will be f oll o we d u ntil t he 
e n d of t he st u d y. 
H y perse nsiti vit y  reacti o ns, IR R, T L S, C R S are t o be re p orte d as A Es (all gra des).
6. 9. 4. He m at o p oietic Gr o wt h F act ors a n d Bl o o d Pr o d uct Tr a nsf usi o ns
Partici pa nts m ust ha ve a de q uate he mat ol o gical f u ncti o n wit h n o tra nsf usi o n or c ol o n y  
sti m ulati n g fact or or er yt hr o p oiesis-sti m ulati n g a ge nt f or at least 2 wee ks pri or t o C 1 D 1 t o be 
eli gi ble t o partici pate i n t his st u d y.
Pri mar y  pr o p h ylactic use of c ol o n y sti m ulati n g fact ors or er yt hr o p oiesis-sti m ulati n g a ge nts is 
n ot per mitte d d uri n g t he first 2 8 da y s of P hase 1 b C 1, ie, D LT o bser vati o n peri o d. 
If he mat o p oietic gr o wt h fact ors or bl o o d pr o d uct tra nsf usi o ns are re q uire d t o ma na ge a n A E 
t hat di d n ot meet D L T criteria, t he D L R tea m ma y deter mi ne if t he A E is a D LT or t hat t he 
partici pa nt is n ot D L T -e val ua ble (a n d ma y nee d t o be re place d).
6. 9. 5. C ortic oster oi ds 
T he use of s ys te mic c ortic oster oi ds is ge nerally disc o ura ge d beca use t heir p ote ntial 
a nti-l ym p h o ma acti vit y  i n patie nts wit h D L B C L ma y c o nf o u n d i nter pretati o n of a ntit u m or 
effects me diate d b y st u d y dr u g treat me nt. H o we ver c hr o nic s yste mic c ortic oster oi ds i n d oses 
u p t o 1 0 m g/ da y  pre d nis o ne or e q ui vale nt (ie, e q ui p ote nt c ortic oster oi d) are per mitte d, 
pr o vi de d t he d osi n g is sta ble ( n ot i ncrease d wit hi n t he last m o nt h), b ut o nl y  f or t he treat me nt 
of n o n -ne o plastic c o m or bi d i n dicati o ns (e g, r he u mat oi d art hritis).

C hr o nic s y ste mic c ortic oster oi d use ( pre d niso ne > 1 0 m g/ da y  or e q ui vale nts) f or 
palliati ve or s u p p orti ve p ur p oses is n ot per mitte d.

Ac ute e mer ge nc y  a d mi nistrati o n of s yste mic c ortic oster oi ds (> e q ui vale nt of 
pre d nis o ne 1 0 m g / da y) is disc o ura ge d, b ut per mitte d if n o alter nati ve t hera p y is 
a vaila ble.

Ac ute e mer ge nc y  a d mi nistrati o n of t o pical a p plicati o ns, i n hale d s pra ys, e ye dr o ps, or 
l ocal i njecti o ns of c ortic oster oi ds are all o we d. 

C ortic oster oi ds ma y  be gi ve n pri or t o tafasita ma b as per S m P C a n d w he n i n dicate d 
f or I R R or t o xicit y ma na ge me nt.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 5
6. 9. 6. I nfecti o n P r o p h yl a xis a n d V acci nes
I n vesti gat ors s h o ul d f oll o w i nstit uti o nal g ui deli nes c o ncer ni n g i nfecti o n pr o p h yla xis f or 
partici pa nts re gar de d t o be at hi g h ris k f or i nfecti o n.
Li ve vacci nes m ust n ot be a d mi nistere d t o partici pa nts i n t his st u d y . 
C O VI D -1 9 vacc i nes (a p pr o ve d or gi ve n b y e mer ge nc y use a ut h orizati o n, i ncl u di n g b ut n ot 
li mite d t o m R N A vacci nes, a n d e xcl u di n g atte n uate d vir us vacci nes) are per mitte d a n d 
s h o ul d be rec or de d as c o nc o mita nt me dicati o ns i n t he C R F. All d oses of vacci ne a n d t y p e of 
vacci n e a d mi nistere d will be rec or de d i n t he C R F. T he ti mi n g of vacci ne a d mi nistrati o n 
relati ve t o st u d y i nter ve nti o n is at t he discreti o n of t he i n vesti gat or alt h o u g h, if p ossi ble, it is 
best t o a v oi d vacci ne a d mi nistrati o n wit hi n 4 8 h o urs bef ore or after t he f irst a n d sec o n d d oses 
of st u d y  i nter ve nti o n.
6. 9. 7. S ur ger y
Ca uti o n is a d vise d f or a n y  s ur gical pr oce d ures d uri n g t he st u d y. T he a p pr o priate i nter val of 
ti me bet wee n s ur ger y a n d st u d y treat me nt re q uire d t o mi ni mize t he ris k of i m paire d w o u n d 
heali n g a n d blee di n g has n ot bee n deter mi ne d. P ost o perati vel y, t he decisi o n t o rei nitiate 
st u d y treat me nt s h o ul d be base d o n a cli nical assess me nt of satisfact or y w o u n d heali n g a n d 
rec o ver y fr o m s ur ger y. 
6. 9. 8. R a di ot her a p y
After t he baseli ne P E T/ C T sca n, ra di ot hera p y is t o be disc usse d wit h t he S p o ns or pri or t o 
i nitiati o n.
7. DI S C O N TI N U A TI O N O F S T U D Y I N T E R V E N TI O N A N D P A R TI CI P A N T 
DI S C O N TI N U A TI O N/ WI T H D R A W A L
7. 1. Disc o nti n u ati o n of St u d y I nter ve nti o n
It ma y be necessar y f or a partici pa nt t o per ma ne ntl y disc o nti n ue st u d y i nter ve nti o n. Reas o ns 
f or per ma ne nt disc o nti n uati o n of st u d y i nter ve nti o n may i ncl u de t he f oll o wi n g:

O bjecti ve disease pr o gressi o n;

Gl o bal deteri orati o n of healt h stat us re q uiri n g disc o nti n uati o n;

U nacce pta ble t o xicit y ;

Pre g na nc y ;

Si g nifica nt pr ot oc ol vi olati o n;

L ost t o f oll o w - u p;

Partici pa nt ref use d f urt her treat me nt;
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 6

St u d y  ter minate d b y s p o ns or;

Deat h.
N ote t hat disc o nti n uati o n of st u d y  i nter ve nti o n d oes n ot re prese nt wit h dra wal fr o m t he st u d y. 
If st u d y i nter ve nti o n is per ma ne ntly disc o nti n ue d, t he partici pa nt s h o ul d re mai n i n t he st u d y 
t o be e val uate d f or safety. See t he S o A f or data t o be c ollecte d at t he ti me of disc o nti n uati o n 
of st u d y  i nter ve nti o n a n d f oll o w-u p f or a n y f urt her e val uati o ns t hat nee d t o be c o m plete d.
I n t he e ve nt of disc o nti n uati o n of st u d y i nter ve nti o n, it m ust be d oc u me nte d o n t he 
a p pr o priate C R F/i n t he me dical rec or ds w het her t he partici pa nt is disc o nti n ui n g f urt her 
recei pt of st u dy i nter ve nti o n or als o fr o m st u d y  pr oce d ures, p osttreat me nt st u d y f oll o w- u p, 
a n d/ or f ut ure c ollecti o n of a d diti o nal i nf or mati o n.
7. 1. 1. C O VI D - 1 9 
If a partici pant has C O VI D -1 9 d uri n g t he st u d y , t his m ust be re p orte d as a n A E or S A E (as 
a p pr o priate) a n d a p pr o priate me dical i nter ve nti o n pr o vi de d. Te m p orar y  disc o nti n uati o n of 
t he st u d y i nter ve nti o n ma y be me dically a p pr o priate u ntil t he partici pa nt has rec o vere d fr o m 
C O VI D -1 9. Partici pa nts wit h C O VI D- 1 9 s y m pt o ms or e x p ose d t o C O VI D- 1 9 s h o ul d be 
teste d a n d treate d as all o we d by l ocal re g ulati o ns.
It is rec o m me n de d t hat t he i n vesti gat or disc uss te m p orar y or per ma ne nt disc o nti n uati o n of 
st u d y i nter ve nti o n wit h t he st u d y me dical m o nit or. 
7. 2. P artici p a nt Disc o nti n u ati o n/ Wit h dr a w al Fr o m t he St u d y 
A partici pa nt ma y  wit h dra w fr o m t he st u d y at a ny ti me at t heir o w n re q uest. Reas o ns f or 
disc o nti n uati o n fr o m t he st u d y  ma y i ncl u de:

Wit h dra wal b y  partici pa nt;

L ost t o f oll o w - u p;

Deat h;

St u d y  ter mi nate d b y sp o ns or.
If a partici pa nt wit h dra ws fr o m t he st u d y, t he y ma y re q uest destr ucti o n of a n y re mai ni n g 
sa m ples ta ke n a n d n ot teste d, a n d t he i n vesti gat or m ust d oc u me nt a n y s uc h re q uests i n t he 
site st u d y rec or ds a n d n otif y t he s p o ns or acc or di n gl y.
If t he partici pa nt wit h dra ws fr o m t he st u d y a n d als o wit h dra ws c o nse nt (see Secti o n 7. 2. 1 ) 
f or discl os ure of f ut ure i nf or mati o n, n o f urt her e val uati o ns will be perf or me d a n d n o 
a d diti o nal data will be c ollecte d. T he s p o ns or ma y retai n a n d c o nti n ue t o use a n y data 
c ollecte d bef ore s uc h wit h dra wal of c o nse nt.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 7
7. 2. 1.
Wit h dr a w al of C o nse nt 
Partici pa nts w h o re q uest t o disc o nti n ue recei pt of st u d y  i nter ve nti o n will re mai n i n t he st u d y 
a n d m ust c o nti n ue t o be f oll o we d f or pr ot oc ol -s pecifie d f oll o w- u p pr oce d ures. T he o nly 
e xce pti o n t o t his is w he n a partici pa nt s pecificall y wit h dra ws c o nse nt f or a n y f urt her c o ntact 
wit h t he m or pers o ns pre vi o usl y  a ut h orize d b y t he partici pa nt t o pr o vi de t his i nf or mati o n. 
Partici pa nts s h o ul d n otif y  t he i n vesti gat or i n writi n g of t he decisi o n t o wit h dra w c o nse nt 
fr o m f ut ure f oll o w-u p, w he ne ver p ossi ble. T he wit h dra wal of c o nse nt s h o ul d be e x plai ne d i n 
detail i n t he me dical rec or ds b y t he i n vesti gat or, as t o w het her t he wit h dra wal is o nl y  fr o m 
f urt her recei pt of st u d y i nter ve nti o n or als o fr o m st u d y pr oce d ures a n d/ or p osttreat me nt st u d y 
f oll o w-u p, a n d e ntere d o n t he a p pr o priate C R F pa ge. I n t he e ve nt t hat vital stat us ( w het her 
t he partici pa nt is ali ve or dea d) is bei n g meas ure d, p u blicl y a vaila ble i nf or mati o n s h o ul d be 
use d t o deter mi ne vital stat us o nl y  as a p pr o priatel y directe d i n acc or da nce wit h l ocal la w.
7. 3. L ost t o F oll o w -U p 
A partici pa nt wi ll be c o nsi dere d l ost t o f oll o w-u p if t he partici pa nt re peate dl y  fails t o ret ur n 
f or sc he d ule d visits a n d is u na ble t o be c o ntacte d b y t he st u d y site.
T he f oll o wi n g acti o ns m ust be ta ke n if a partici pa nt fails t o atte n d a re q uire d st u d y  visit:

T he site m us t atte m pt t o c o ntact t he partici pa nt a n d resc he d ule t he misse d visit as 
s o o n as p ossi ble. C o u nsel t he partici pa nt o n t he i m p orta nce of mai ntai ni n g t he 
assi g ne d visit sc he d ule a n d ascertai n w het her t he partici pa nt wis hes t o a n d/ or s h o ul d 
c o nti n ue i n t he st u d y .

Bef ore a partici pa nt is dee me d l ost t o f oll o w- u p, t he i n vesti gat or or desi g nee m ust 
ma ke e ver y  eff ort t o re gai n c o ntact wit h t he partici pa nt ( w here p ossi ble, 3 tele p h o ne 
calls a n d, if necessar y, a certifie d letter t o t he partici pa nt’s last k n o w n maili n g 
a d dress or l ocal e q ui vale nt met h o ds). T hese c o ntact atte m pts s h o ul d be d oc u me nte d 
i n t he partici pa nt’s me dical rec or d.

S h o ul d t he partici pa nt c o nti n ue t o be u nreac ha ble, t he partici pa nt will be c o nsi dere d 
t o ha ve wit h dra w n fr o m t he st u d y. 
8. S T U D Y A S S E S S M E N T S A N D P R O C E D U R E S
8. 1. A d mi nistr ati ve Pr oce d ures 
T he i n vesti gat or ( or a n a p pr o priate dele gate at t he i n vesti gat or site) m ust o btai n a si g ne d a n d 
date d I C D bef ore perf or mi n g a n y st u d y- s pecific pr oce d ures.
St u d y  pr oce d ures a n d t heir ti mi n g are s u m marize d i n t he S o A . Pr ot oc ol wai vers or 
e xe m pti o ns are n ot all o we d.
A d here nce t o t he st u d y desi g n re q uire me nts, i ncl u di n g t h ose s pecifie d i n t he S o A , is esse ntial 
a n d re q uire d f or st u d y c o n d uct.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 8
All scree ni n g e val uati o ns m ust be c o m plete d a n d re vie we d t o c o nfir m t hat p ote ntial 
partici pa nts meet all eli gi bilit y  criteria. T he i n vesti gat or will mai ntai n a scree ni n g l o g t o 
rec or d details of all partici pa nts scree ne d a n d t o c o nfir m eli gi bilit y or rec or d reas o ns f or 
scree ni n g fail ure, as a p plica ble.
Pr oce d ures c o n d ucte d as part of t he partici pa nt’s r o uti ne cli nical ma na ge me nt (e g, bl o o d 
c o u nt, sca ns) a n d o btai ne d bef ore si g ni n g of t he I C D ma y be utilize d f or scree ni n g or 
baseli ne p ur p oses pr o vi de d t he pr oce d ures met t he pr ot oc ol -s pecifie d criteria a n d were 
perf or me d wit hi n t he ti me fra me defi ne d i n t he S o A .
E ver y  eff ort m ust be ma de t o e ns ure t hat pr ot oc ol-re q uire d tests a n d pr oce d ures are 
c o m plete d as descri be d. H o we ver, it is a ntici pate d t hat fr o m ti me t o ti me t here ma y be 
circ u msta nces o utsi de t he c o ntr ol of t he i n vesti gat or t hat ma ke it u nfeasi ble t o perf or m t he 
test. In t hese cases, t he i n vesti gat or m ust ta ke all ste ps necessar y  t o e ns ure t he safety a n d 
well - bei n g of t he partici pa nt. W he n a pr ot oc ol-re q uire d test ca n n ot be perf or me d, t he 
i n vesti gat or will d oc u me nt t he reas o n f or t he misse d test a n d a ny c orrecti ve a n d pre ve nti ve 
acti o ns t hat t he y ha ve ta ke n t o e ns ure t hat re q uire d pr ocesses are a d here d t o as s o o n as 
p ossi ble. T he st u d y  tea m m ust be i nf or med of t hese i nci de nts i n a ti mel y  ma n ner.
F or sa m ples bei n g c ollecte d a n d s hi p pe d, detaile d c ollecti o n, pr ocessi n g, st ora ge, a n d 
s hi p me nt i nstr ucti o ns a n d c o ntact i nf or mati o n will be pr o vi de d t o t he i n vesti gat or site pri or 
t o i nitiati o n of t he st u d y.
8. 1. 1. Scree n i n g a n d B aseli ne Pr oce d ures 
De m o gra p hic data a n d me dical hist or y  will be c ollecte d at Scree ni n g by t he i n vesti gat or or 
q ualifie d desi g nee, i ncl u di n g rele va nt me dical a n d s ur gical hist or y , a n d c urre nt ill nesses. T he 
me dical hist or y  of D L B C L, i ncl u di n g baseli ne s y m pt o ms as well as a detaile d hist or y  of 
pri or ca ncer t hera pies f or D L B C L, wit h start a n d st o p dates, n u m ber of t hera p y  li ne(s), P D 
d uri n g or after t hera p y, as well as disc o nti n uati o ns d ue t o i nt olera bilit y  or a n y ot her cli nically 
si g nifica nt illness. A n y pre vi o us t hera p y (e g, c he m ot hera py, i m m u n ot hera p y, or ra diati o n 
t hera py) f or D L B C L s h o ul d be rec or de d i n t he e C R F. Als o, e xa mi nati o ns lea di n g t o t he 
dia g n osis of t he latest pr o gressi o n of D L B C L s h o ul d be d oc u me nte d i n t he partici pa nt’s 
s o urce d ocu me nts. T his ma y  i ncl u de, f or e xa m ple, res ults of la b orat or y e xa mi nati o ns, 
i ma gi n g res ults, or cli nical s ym pt o ms relate d t o D L B C L. T he assess me nt of t he l y m p h o ma 
s h o ul d i ncl u de sta gi n g.
I n or der t o reflect t he partici pa nt’s stat us at t he ti me of e nr oll me nt, t he sta n dar d sta gi n g 
s yste m use d f or D L B CL reflecti n g t he n u m ber of sites of i n v ol ve me nt a n d t heir relati o n t o 
t he dia p hra g m, t he e xiste nce of B-s ym pt o ms, a n d t he prese nce of e xtra n o dal disease, will be 
use d (see A p pe n di x 1 1 f or Lu ga n o M o dificati o n of A n n Ar b or Sta gi n g). Disease ris k as per 
I PI (see A p pe n di x 1 4 ) a n d E C O G perf or ma nce stat us (see A p pe n di x 1 3 ) will be rec or de d i n 
t he C R F.
8. 1. 2. F oll o w -U p Visits a n d L T F U
At least 2 8 cale n dar da ys, a n d n o m ore t ha n 3 5 cale n dar da ys after disc o nti n uati o n of st u d y 
i nter ve nti o n, partici pa nts will ret ur n t o u n der g o re vie w of c o nc o mita nt treat me nts, vital si g ns, 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 9
a n d assess me nt f or res ol uti o n of a n y  treat me nt relate d A Es. Partici pa nts c o nti n ui n g t o 
e x perie nce A Es at t his p oi nt f oll o wi n g disc o nti n uati o n of treat me nt will c o nti n ue t o be 
f oll o we d at least e ver y 4 wee ks u ntil res ol uti o n or deter mi nati o n, i n t he cli nical j u d g me nt of 
t he i n vesti gat or, t hat n o f urt her i m pr o ve me nt is e x pecte d.
If t he u nres ol ve d A E is c o nsi dere d by t he i n vesti gat or as p ossi bl y relate d t o or ass ociate d 
wit h A D A f or mati o n, t he partici pa nt ma y  be as ke d t o ret ur n f or A D A bl o o d sa m pli n g at u p 
t o 3 m o nt h i nter vals (if feasi ble gi ve n t he u n derl yi n g disease), u ntil t he A E or its se q uelae 
res ol ve or sta bilize at a le vel acce pta ble t o t he i n vesti gat or a n d s p o ns or u p t o a ma xi m u m of 
9 m o nt hs fr o m t he last st u d y  treat me nt.
T he 9 0 -d a y  p ost-d ose f oll o w -u p visit f or A Es, c o ntrace pti o n c hec k, a n d s u bse q ue nt 
a ntica ncer t hera p y(ies) ma y be perf or me d via re m ote c o ntact (e g, tele p h o ne). T he 
i n vesti gat or ma y c o m plete t hese f oll o w-u p visits i n cli nic if a n y  c o ncer ns are n ote d d uri n g 
t he re m ote c o ntact.
Partici pa nts disc o nti n ue d fr o m st u d y  i nter ve nti o ns bef ore disease pr o gressi o n will e nter t he 
L T F U p hase a n d be c o ntacte d u ntil disease pr o gressi o n, t he start of a ne w a nti -ca ncer t hera p y 
or deat h, w hic he ver c o mes first. Partici pa nts will be c o ntacte d b y  tele p h o ne e ver y 1 2 wee ks 
fr o m t he 9 0-d a y  f oll o w-u p vi sit ( 2 4 wee ks fr o m t he last d ose) t o c o nfir m s ur vi val stat us a n d 
t o c ollect a ny ne w a nti -ca ncer t hera pies. O nsite visits ma y  be re q uire d t o c o n d uct f oll o w- u p 
assess me nts descri be d i n t he S o A ( Secti o n 1. 3 ), i ncl u di n g sca ns.
8. 2. Effic ac y Assess me nts
All disease res p o nses will be assesse d acc or di n g t o t he L u ga n o Res p o nse Classificati o n 
Criteria (A p pe n di x 1 2 ), wit h i nterpretati o n acc or di n g t o t he 5 p oi nt scale.
Pse u d o -pr o gressi o n, w hic h has bee n o bser ve d i n l y m p h o ma patie nts o n le nali d o mi de a n d 
ot her i m m u ne t hera pies, will be ma na ge d as per refi ne d L u ga n o criteria 2 0 1 6 ( L Y RI C). I n 
cases w here pse u d o - pr o gressi o n is s us pecte d, w he n meeti n g L u ga n o 2 0 1 6 criteria f or 
‘i n deter mi nate res p o nse’, t he partici pa nt ma y c o nti n ue t o recei ve st u d y treat me nt. As per 
L u ga n o 2 0 1 6, a bi o ps y (if safe a n d feasi ble), or a re peat sca n wit hi n 1 2 wee ks ma y be 
i n dicate d (A p pe n di x 1 2 ); f or t his st u d y, it is rec o m me n de d t hat o nl y ne w lesi o ns ( prese nti n g 
after baseli ne) are bi o psie d (t o be disc usse d wit h s p o ns or as nee de d). P D will be e ntere d i n 
t he C R F o nl y u p o n c o nfir mati o n of P D o n s u bse q ue nt sca n. T u m or flare/ pse u d o -pr o gressi o n 
will be re p orte d as a n A E.
Ra di ol o gical assess me nt will be perf or me d at Scree ni n g, d uri n g treat me nt as s pecifie d i n t he 
S o A , w he ne ver P D is s us pecte d (e g, sy m pt o matic deteri orati o n), a n d at t he ti me of 
wit h dra wal fr o m st u d y treat me nt (if n ot d o ne i n t he pre vi o us c y cle). All sca ns/assess me nts, 
i ncl u di n g u n pla n ne d sca ns ( or sca ns i n a d diti o n t o t he S o A ) are t o be rec or de d i n t he C R F.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 0
Ra di o gra p hic i ma gi n g e val uati o n s h o ul d i ncl u de dia g n ostic q ualit y  CT/ M RI a n d F D G P E T per 
L u ga n o criteria. A n d t he f oll o wi n g s h o ul d be n ote d:

I ma gi n g d o ne u p t o 4 2 da ys pri or t o d osi n g ( bef ore IC D is si g ne d) ca n be use d f or 
scree ni n g a n d as baseli ne assess me nt if it is perf or me d per sta n dar d of care as per 
pr ot oc ol re q uire me nts. 

I ma gi n g sc he d ule is t o be mai ntai ne d irres pecti ve of d ose dela ys or i nterr u pti o n.

I ma gi n g is re q uire d at t he E O T visit if t he partici pa nt has wit h dra w n fr o m treat me nt 
f or reas o n ot her t ha n pr o gressi o n a n d i ma gi n g has n ot perf or me d i n t he c y cle bef ore 
t he E O T visit.

If st u d y i nter ve nti o n is disc o nti n ue d pri or t o P D, sca ns are t o c o nti n ue irres pecti ve of 
ot her i nter ve ni n g treat me nt u ntil P D is d oc u me nte d.
All partici pa nts’ files a n d ra di ol o gic i ma ges a n d pat h ol o g y  sa m ples m ust be a vaila ble f or 
s o urce verificati o n a n d f or p ote ntial peer re vie w; ra di o gra p hic i ma ges utilize d f or efficac y 
assess me nts ma y be c ollecte d a n d st ore d by a n i n de pe n de nt t hir d part y i ma gi n g la b orat or y, 
(see I ma gi n g Ma n ual f or details).
If a partici pa nt wit h d oc u me nte d P D per L u ga n o criteria2 7 c o nti n ues t o e x perie nce cli nical 
be nefit, per i n vesti gat or’s cli nical j u d g me nt t he st u d y  treat me nt wit h P F-0 7 9 0 1 8 0 1 a n d 
tafasita ma b ma y c o nti n ue u ntil n o l o n ger cli nicall y be nefiti n g as per a ris k-be nefit 
assess me nt b y t he i n vesti gat or. T he first o bser vati o n of P D, pri or t o c o nti n uati o n of t hera py, 
will be d oc u me nte d i n t he C R F a n d c o nsi dere d t he date of P D.
8. 2. 1. C o m p ute d T o m o gr a p h y Sc a ns
C T sca ns of t he c hest, a b d o me n, a n d pel vis ( nec k s h o ul d be i ncl u de d, if a p pr o priate a n d as 
cli nicall y i n dicate d) will be perf or me d t o assess disease at Scree ni n g a n d per assess me nt 
sc he d ule i n t he S o A . All C T sca ns s h o ul d be perf or me d wit h I V c o ntrast a n d a b d o mi nal a n d 
pel vic C T sca ns s h o ul d be perf or me d wit h oral or I V c o ntrast u nless c o ntrai n dicate d (see 
I ma gi n g Ma n ual f or details). H ybri d P E T -C T sca n ners ma y  be use d t o ac q uire t he re q uire d 
C T i ma ges o nl y if C T pr o d uce d b y t he sca n ner is of dia g n ostic q ualit y, a d heres t o s pecifie d 
sca n para meters, a n d i ncl u des I V c o ntrast ( u nless me dicall y c o ntrai n dicate d). N o n- dia g n ostic 
C T i ma ges ac q uire d f or atte n uati o n p ur p oses d uri n g P E T - C T are N O T acce pta ble as t he o nly 
C T sca n f or t he ti me p oi nt. Dia g n ostic C T i ma ges wit h c o ntrast ( u nless me dicall y  
c o ntrai n dicate d) wit h a sta n dal o ne C T sca n ner m u st be ac q uire d if P E T-C T is u na ble t o 
ac q uire dia g n ostic C T i ma ges. If t he dia g n ostic C T a n d P E T are ac q uire d o n t he sa me da y , it 
is str o n gly rec o m me n de d t hat t he P E T is perf or me d pri or t o t he C T wit h I V c o ntrast as t o n ot 
c o m pr o mise P E T res ults. M RI  or P ET/ M RI ca n be use d i n place of C T if a partici pa nt ca n n ot 
t olerate C T c o ntrast a ge nt or as cli nically i n dicate d. T he sa me i ma gi n g m o dalit y  s h o ul d be 
use d f or a gi ve n partici pa nt t hr o u g h o ut t he st u d y d urati o n.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 1
8. 2. 2. P ositr o n E missi o n T o m o gr a p h y Sc a ns
A P E T sca n wi t h F D G e xte n di n g fr o m t he nec k t hr o u g h t he mi d t hi g hs will be perf or me d t o 
assess baseli ne disease at Scree ni n g a n d t o assess disease res p o nse as per t he S o A ; i n 
a d diti o n t o t he F D G-P E T i ma gi n g a dia g n ostic q ualit y c o ntrast -e n ha nce d C T sca n m ust be 
i ncl u de d f or lesi o n meas ure me nts. E xa mi nati o ns s h o ul d be c o nsiste nt acr oss all ti me p oi nts, 
i ncl u di n g a m o u nt of tracer, l ocati o n of i njecti o n, ar m p ositi o n, a n d sca n dela y. N ote t hat if a 
partici pa nt ac hie ves a meta b olic C R, P E T sca ns are n ot re q uire d at s u bse q ue nt assess me nts. 
A d diti o nal P E T/ C T or C T or M RI  e xa mi nati o ns ma y be perf or me d b y t he i n vesti gat or i n t he 
c o urse of t he st u d y, if dee me d necessar y (e g, if P D is s us pecte d, t o c o nfir m t he occ urre nce of 
a C R or t o ma ke i m p orta nt treat me nt-relate d decisi o ns). If t he partici pa nt disc o nti n ues fr o m 
st u d y i nter ve nti o n, a P E T/ C T sca n is o nl y re q uire d at t he E O T if it was n ot perf or me d i n t he 
c ycle pri or t o t he E O T. C T ma y be perf or me d i n lie u of P E T/ C T if t he partici pa nt 
disc o nti n ues fr o m st u d y  i nter ve nti o n wit hi n C 1.
8. 3. S afet y Assess me nts
Pla n ne d ti me p oi nts f or all safet y  assess me nts are pr o vi de d i n S o A . U nsc he d ule d safety 
meas ure me nts ma y  be o btai ne d at a n y ti me d uri n g t he st u d y t o assess a n y percei ve d safet y 
iss ues.
8. 3. 1. P h ysic al E x a mi n ati o ns
A c o m plete P E will be perf or me d at Scree ni n g a n d is t o i ncl u de, at a mi ni m u m, assess me nts 
of t he car di o vasc ular, res pirat or y , gastr oi ntesti nal, a n d ne ur ol o gical sys te ms. 
Tar gete d/s y m pt o m -directe d P Es, i ncl u di n g si g ns a n d s y m pt o ms of t he disease u n der st u d y , 
will be c o n d ucte d at ot her visits as per t he S o A . Hei g ht will be c ollecte d at baseli ne a n d 
wei g ht will be meas ure d a n d rec or de d as per t he S o A .
P Es ma y  be c o n d ucte d b y a ph y sicia n, trai ne d p h ysicia n’s assista nt, or n urse practiti o ner as 
acce pta ble acc or di n g t o l ocal re g ulati o n.
P E fi n di n gs c ollecte d d uri n g t he st u d y will be c o nsi dere d s o urce data a n d will n ot be re q uire d 
t o be re p orte d, u nless ot her wise n ote d. A ny u nt o war d P E fi n di n gs t hat are i de ntifie d d uri n g 
t he acti ve c ollecti o n peri o d a n d meet t he defi niti o n of a n A E or S A E (A p pe n di x 3 ) m ust be 
re p orte d acc or di n g t o t he pr ocesses i n Secti o ns 8. 4. 1 t o 8. 4. 3 .
W he n s h o ul d it be d o ne:
P E is t o be perf or me d pri or t o i nf usi o n of st u d y  i nter ve nti o n.
8. 3. 2. Vit al Si g ns
Pre - d ose vital si g ns will be re p orte d o n t he C R F. All ot her vital si g ns c ollecte d d uri n g t he 
c o urse of t he st u d y will be c o nsi dere d s o urce data o nl y  a n d will n ot be re q uire d t o be 
re p orte d o n t he C R F. 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 2
A n y  u nt o war d vital si g n fi n di n gs t hat are i de ntifie d d uri n g t he acti ve c ollecti o n peri o d a n d 
meet t he defi niti o n of a n A E or S A E ( A p pe n di x 3 ) m ust be re p orte d acc or di n g t o t he 
pr oces ses i n Secti o n 8. 4. 1 t o Secti o n 8. 4. 3 .
8. 3. 2. 1. Bl o o d Press ure a n d P ulse R ate
B P a n d P R meas u re me nts will be assesse d per i nstit uti o nal sta n dar ds wit h a c o m pletel y 
a ut o mate d de vice. Ma n ual tec h ni q ues will be use d o nl y  if a n a ut o mate d de vice is n ot 
a vaila ble.
Vital si g ns will be ta ke n bef ore bl o o d c ollecti o n f or la b orat or y  tests.
I n case of l o gistical iss ue, t he vitals ca n be ta ke n after bl o o d c ollecti o n f or la b orat or y  tests 
after t he partici pa nt has reste d as per sta n dar d of care.  
Vital si g ns c o nsist of a si n gle meas ure me nt of P R a n d si n gle B P meas ure me nt.
8. 3. 2. 2. Te m per at ure a n d Res pir at or y R ate
Te m pera t ure a n d res pirat or y rate fi n di n gs c ollecte d d uri n g t he st u d y will be c o nsi dere d 
s o urce data a n d will n ot be re q uire d t o be re p orte d, u nless ass ociate d wit h a n A E/ S A E or 
ot her wise n ote d.
8. 3. 3. Electr oc ar di o gr a ms
Sta n dar d 1 2 -lea d E C Gs utilizi n g li m b lea ds ( wit h a 1 0-sec o n d r h yt h m stri p) s h o ul d be 
c ollecte d at ti mes s pecifie d i n t he S o A secti o n of t his pr ot oc ol usi n g a n E C G mac hi ne t hat 
a ut o maticall y calc ulates t he heart rate a n d meas ures P R i nter val, Q T i nter val, Q Tc F, a n d 
Q R S c o m ple x. F or E C G mac hi nes t hat d o n ot re p ort Q Tc F, calc ulati o n of Q Tc F fr o m Q T 
a n d heart rate, f or e xa m ple usi n g o nli ne t o ols, is re q uire d. Alter nati ve lea d place me nt 
met h o d ol o g y  usi n g t ors o lea ds (e g, Mas o n- Li kar) s h o ul d n ot be use d gi ve n t he p ote ntial ris k 
of discre pa ncies wit h E C Gs ac q uire d usi n g sta n dar d li m b lea d place me nt. All sc he d ule d 
E C Gs s h o ul d be perf or me d after t he partici pa nt has reste d q uietl y  f or at least 5 mi n utes i n a 
s u pi ne p ositi o n. 
If a) a p ost-d ose Q Tc F i nter val re mai ns ≥6 0 ms fr o m t he baseli ne a n d is > 4 5 0 ms; or b) a n 
a bs ol ute Q T val ue is ≥5 0 0 ms f or a n y sc he d ule d E C G f or greater t ha n 4 h o urs ( or s o o ner, at 
t he discreti o n of t he i n vesti gat or); or c) Q Tc F i nter vals get pr o gressi vel y l o n ger, t he 
partici pa nt s h o ul d u n der g o c o nti n u o us E C G m o nit ori n g. 
A car di ol o gist s h o ul d be c o ns ulte d if Q Tc F val ues d o n ot ret ur n t o less t ha n t he criteria liste d 
a bo ve after 8 h o urs of m o nit ori n g ( or s o o ner, at t he discreti o n of t he i n vesti gat or). 
I n s o me cases, it ma y be a p pr o priate t o re peat a b n or mal E C Gs t o r ule o ut i m pr o per lea d 
place me nt as c o ntri b uti n g t o t he E C G a b n or malit y. It is i m p orta nt t hat lea ds be plac e d i n t he 
sa me p ositi o ns eac h ti me i n or der t o ac hie ve precise E C G rec or di n gs. If a mac hi ne-rea d 
Q Tc F val ue is pr ol o n ge d, as defi ne d a b o ve, re peat meas ure me nts ma y  n ot be necessar y if a 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 3
q ualifie d me dical pr o vi der’s i nter pretati o n deter mi nes t hat t he Q Tc F v al ues are i n t he 
acce pta ble ra n ge.
E C G val ues of p ote ntial cli nical c o ncer n are liste d i n A p pe n di x 8 .
W he n s h o ul d it be d o ne:
E C G assess me nts s h o ul d prece de bl o o d c ollecti o n f or cli nical la b orat or y  tests. In case of 
l o gistical iss ue, E C G ca n be perf or me d after bl o o d c ollecti o n f or cli nical la b orat or y tests 
after t he partici pa nt has reste d q uietl y  f or at least 5 mi n utes i n a s u pi ne p ositi o n.
8. 3. 4. Cli nic al S afet y L a b or at or y Assess me nts
See A p pe n di x 2 f or t he list of cli nical safety la b orat or y  tests t o be perf or me d a n d t he S o A f or 
t he ti mi n g a n d fre q ue nc y. All pr ot oc ol-re q uire d la b orat or y assess me nts, as defi ne d i n 
A p pe n di x 2 , m ust be c o n d ucte d i n acc or da nce wit h t he La b orat or y  Ma n ual a n d t he S o A . 
U nsc he d ule d cli nical la b orat or y  meas ure me nts ma y be o btai ne d at a n y ti me d uri n g t he st u d y 
t o assess a ny percei ve d safet y iss ues a n d res ults rec or de d i n t he C R F.
T he i n vesti gat or m ust re vie w t he la b orat or y  re p ort pri or t o t he i nf usi o ns, d oc u me nt t his 
re vie w, a n d rec or d a ny cli nicall y si g nifica nt c ha n ges occ urri n g d uri n g t he st u d y i n t he A E 
secti o n of t he C R F. Cli nicall y si g nifica nt a b n or mal la b orat or y test fi n di ngs are t h ose t hat are 
n ot ass ociate d wit h t he u n derl y i n g disease, u nless j u d ge d b y t he i n vesti gat or t o be m ore 
se vere t ha n e x pecte d f or t he partici pa nt’s c o n diti o n.
All la b orat or y  tests wit h val ues c o nsi dere d cli nicall y si g nifica nt a n d a b n or mal d uri n g 
partici pati o n i n t he st u d y  or wit hi n 2 8 cale n dar da ys after t he last a d mi nistrati o n of 
P F -0 7 9 0 1 8 0 1 a n d/ or le nali d o mi de or 9 0 da y s after t he last a d mi nistrati o n of tafasita ma b 
s h o ul d be re peate d u ntil t he val ues ret ur n t o n or mal or baseli ne or are n o l o n ger c o nsi dere d 
cli nicall y si g nifica nt by t he i n vesti gat or or st u d y me dical m o nit or.
If s uc h val ues d o n ot ret ur n t o n or mal/ baseli ne wit hi n a peri o d of ti me j u d ge d reas o na ble b y 
t he i n vesti gat or, t he eti ol o g y s h o ul d be i de ntifie d a n d t he s p o ns or n otifie d.
See A p pe n di x 6 f or s u g geste d acti o ns a n d f oll o w- u p assess me nts i n t he e ve nt of p ote ntial 
DI LI.
See A p pe n di x 7 f or i nstr ucti o ns f or la b orat or y testi n g t o m o nit or ki d ne y f u ncti o n a n d 
re p orti n g la b orat or y test a b n or malities.
Scree ni n g la b orat ories ma y  be use d as pre-d ose baseli ne if t he y  are wit hi n 3 da ys of C 1 D 1, 
a n d t heref ore t here is n o nee d t o re peat cli nical la b orat or y  assess me nts o n C 1 D 1 i n t his case. 
If la b orat or y val ues are n ot wit hi n eli gi bilit y , bl o o d test ma y be re peate d o nce.
All safet y la b orat or y  res ults m ust be a vaila ble pri or t o d osi n g t o deter mi ne if d ose 
m o dificati o ns are necessar y ; m a y be dra w n u p t o 7 2 h o urs pri or t o d osi n g visit date.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 4
8. 3. 4. 1. Alter n ati ve F acilities f or Cli nic al S afet y L a b or at or y Assess me nt
Pr ot oc ol -s pecifie d safety la b orat or y e val uati o ns (refer t o S o A ) ma y be c o n d ucte d at a l ocal 
la b orat or y, d uri n g a m o bile visit, or at h o me if per mitte d b y l ocal re g ulati o ns. T he l ocal 
la b orat or y ma y be a sta n dal o ne i nstit uti o n or wit hi n a h os pital. 
If a l ocal la b orat or y is use d, q ualifie d st u d y site pers o n nel m ust or der, recei ve, a n d re vie w 
res ults. Site staff m ust c ollect t he l ocal la b orat or y refere nce ra n ges a n d 
certificati o ns/accre ditati o ns f or fili n g at t he site. La b orat or y  test res ults are t o be pr o vi de d t o 
t he site staff as s o o n as p ossi ble. T he l ocal la b orat or y  re p orts s h o ul d be file d i n t he 
partici pa nt’s s o urce d oc u me nts/ me dical rec or ds. Rele va nt data fr o m t he l ocal la b orat or y  
re p ort s h o ul d be rec or de d o n t he C R F.
8. 3. 5. Pre g n a nc y Testi n g
Pre g na nc y  tests will be perf or me d i n W O C B P at t he ti mes liste d i n t he S o A . A ser u m 
pre g na nc y  test is re q uire d at Scree ni n g. F oll o wi n g scree ni n g, pre g na nc y tests ma y be uri ne or 
ser u m tests, a n d m ust ha ve a se nsiti vit y of at least 2 5 mI U/ m L H C G. F oll o wi n g a ne gati ve 
pre g na nc y  test res ult at Scree ni n g, a p pr o priate c o ntrace pti o n m ust be c o m me nce d a n d a 
sec o n d ne gati ve pre g na nc y test res ult will be re q uire d at t he baseli ne visit pri or t o t he 
partici p a nt’s recei vi n g t he st u d y treat me nt. Pre g na nc y tests will als o be d o ne w he ne ver 
1 me nstr ual c y cle is misse d d uri n g t he acti ve treat me nt peri o d ( or w he n p ote ntial pre g na nc y  
is ot her wise s us pecte d) a n d at t he e n d of t he st u dy. A d diti o nal pre g na nc y  tests m ust be 
perf or me d per t he l ocal le nali d o mi de la bel.
Pre g na nc y  tests ma y als o be re peate d if re q ueste d b y IR Bs/ E Cs or if re q uire d b y  l ocal 
re g ulati o ns. If a uri ne test ca n n ot be c o nfir me d a s ne gati ve (e g, a n a m bi g u o us res ult), a 
ser u m pre g na nc y test is re q uired. I n s uc h cases, t he partici pa nt m ust be e xcl u de d if t he ser u m 
pre g na nc y  res ult is p ositi ve.
C o ns ult als o t he le nali d o mi de P P P ( Secti o n 1 0. 4. 5 ).
8. 3. 6. B- S y m pt o ms
Assess me nt of t he prese nce or a bse nce of B -s ym pt o ms will be perf or me d at Scree ni n g a n d 
o n Da y  1 f or all c ycles, as well as t he E O T.
B- s ym pt o ms are defi ne d as t he prese nce of: (a) u ni nte nti o nal wei g ht l oss of m ore t ha n 1 0 % 
wit hi n t he pre vi o us 6 m o nt hs, a n d/ or ( b) persiste nt or rec urre nt fe vers of 3 8. 0° C wit h o ut 
ot her e vi de nce of i nfecti o n, a n d/ or (c) dre nc hi n g ni g ht s weats wit h o ut e vi d e nce of i nfecti o n.
8. 4. A d verse E ve nts, Seri o us A d verse E ve nts, a n d Ot her S afet y Re p orti n g
T he defi niti o ns of a n A E a n d a n S A E ca n be f o u n d i n A p pe n di x 3 .
A Es ma y  arise fr o m sy m pt o ms or ot her c o m plai nts re p orte d t o t he i n vesti gat or b y  t he 
partici pa nt ( or, w he n a p pr o priate, b y a care gi ver, s urr o gate, or t he partici pa nt’s le gall y 
a ut h orize d re prese ntati ve), or t he y  ma y arise fr o m cli nical fi n di n gs of t he i n vesti gat or or 
ot her healt hcare pr o vi ders (cli nical si g ns, test res ult s, etc).
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 5
T he i n vesti gat or a n d a n y q ualifie d desi g nees are res p o nsi ble f or detecti n g, d oc u me nti n g, a n d 
rec or di n g e ve nts t hat meet t he defi niti o n of a n A E or S A E a n d re mai n res p o nsi ble t o p urs ue 
a n d o btai n a de q uate i nf or mati o n b ot h t o deter mi ne t he o utc o me a n d t o assess w het her t he 
e ve nt meets t he criteria f or classificati o n as a n S A E or ca use d t he partici pa nt t o disc o nti n ue 
t he st u d y i nter ve nti o n (see Secti o n 7. 1 ).
D uri n g t he acti ve c ollecti o n peri o d as descri be d i n Secti o n 8. 4. 1 eac h partici pa nt will be 
q uesti o ne d a b o ut t he occ urre nce of A Es i n a n o nlea di n g ma n ner. 
I n a d diti o n, t he i n vesti gat or ma y be re q ueste d by P fizer Safety t o o btai n s pecific f oll o w - u p 
i nf or mati o n i n a n e x pe dite d fas hi o n.
8. 4. 1. Ti me Peri o d a n d Fre q ue nc y f or C ollecti n g A E a n d S A E I nf or m ati o n
T he ti me peri o d f or acti vel y  eliciti n g a n d c ollecti n g A Es a n d S A Es (“acti ve c ollecti o n 
peri o d”) f or eac h partici pa nt be gi ns fr o m t he ti me t he partici pa nt pr o vi des i nf or me d c o nse nt, 
w hic h is o btai ne d bef ore u n der g oi n g a n y st u d y- relate d pr oce d ure a n d/ or recei vi n g st u d y 
i nter ve nti o n, t hr o u g h a n d i ncl u di n g a mi ni m u m of 2 8 cale n dar da ys after t he last 
a d mi nistrati o n of P F -0 7 9 0 1 8 0 1 a n d/ or le nali d o mi de or 9 0 da y s after t he last a d mi nistrati o n 
of tafasita ma b, w hic he ver is l o n ger.
F oll o w -u p b y  t he i n vesti gat or c o nti n ues t hr o u g h o ut a n d after t he acti ve c ollecti o n peri o d a n d 
u ntil t he A E or S A E or its se q uelae res o l ve or sta bilize at a le vel acce pta ble t o t he 
i n vesti gat or.
W he n a cli nicall y  i m p orta nt A E re mai ns o n g oi n g at t he e n d of t he acti ve c ollecti o n peri o d, 
f oll o w-u p b y  t he i n vesti gat or c o nti n ues u ntil t he A E or S A E or its se q uelae res ol ve or 
sta bilize at a le vel acce pta ble t o t he i n vesti gat or a n d Pfizer c o nc urs wit h t hat assess me nt.
F or partici pa nts w h o are scree n fail ures, t he acti ve c ollecti o n peri o d e n ds w he n scree n fail ure 
stat us is deter mi ne d.
If t he partici pa nt wit h dra ws fr o m t he st u d y a n d als o wit h draws c o nse nt f or t he c ollecti o n of 
f ut ure i nf or mati o n, t he acti ve c ollecti o n peri o d e n ds w he n c o nse nt is wit h dra w n.
If a partici pa nt per ma ne ntl y disc o nti n ues or te m p orarily disc o nti n ues st u d y i nter ve nti o n 
beca use of a n A E or S A E, t he A E or S A E m ust be rec or d e d o n t he C R F a n d t he S A E 
re p orte d usi n g t he C T S A E Re p ort F or m.
I n vesti gat ors are n ot o bli gate d t o acti vely see k i nf or mati o n o n A Es or S A Es after t he 
partici pa nt has c o ncl u de d st u d y partici pati o n . H o we ver, if t he i n vesti gat or lear ns of a ny S A E, 
i ncl u di n g a deat h, at a n y ti me after a partici pa nt has c o m plete d t he st u dy, a n d t he y c o nsi der 
t he e ve nt t o be reas o na bl y relate d t o t he st u dy i nter ve nti o n, t he i n vesti gat or m ust pr o m ptl y  
re p ort t he S A E t o Pfizer usi n g t he C T S A E Re p ort F or m. I n a d diti o n, if t he i n vesti gat or 
lear ns of a ny s ec o n d pri mar y mali g na nc y, irres pecti ve of ca usalit y or ti me of dia g n osis, t he 
i n vesti gat or m ust pr o m ptl y re p ort t he S A E t o Pfizer.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 6
8. 4. 1. 1. Re p orti n g S A Es t o Pfizer S afet y
All S A Es occ urri n g i n a partici pa nt d uri n g t he acti ve c ollecti o n peri o d as descri be d i n 
Secti o n 8. 4. 1 are re p orte d t o Pfizer Safet y o n t he C T S A E Re p ort F or m i m me diatel y u p o n 
a ware ness a n d u n der n o circ u msta nce s h o ul d t his e xcee d 2 4 h o urs, as i n dicate d i n 
A p pe n di x 3 . T he i n vesti gat or will s u b mit a n y u p date d S A E data t o t he s p o ns or wit hi n 
2 4 h o urs of its bei n g a vaila ble.
If a partici pa nt be gi ns a ne w a ntica ncer t hera py, S A Es occ urri n g d uri n g t he a b o ve- i n dicate d 
acti ve c ollecti o n peri o d m ust still be re p orte d t o Pfizer Safet y  irres pecti ve of a n y i nter ve ni n g 
treat me nt. N ote t hat a s witc h t o a c o m mercially a vaila ble versi o n of t he st u d y i nter ve nti o n is 
c o nsi dere d as a ne w a ntica n cer t hera p y f or p ur p oses of S A E re p orti n g.
8. 4. 1. 2. Rec or di n g N o nseri o us A Es a n d S A Es o n t he C R F
All n o nseri o us A Es a n d S A Es occ urri n g i n a partici pa nt d uri n g t he acti ve c ollecti o n peri o d 
w hic h be gi ns after o btai ni n g i nf or me d c o nse nt as descri be d i n Secti o n 8. 4. 1 , will be rec or de d 
o n t he A E secti o n of t he C R F. 
T he i n vesti gat or is t o rec or d o n t he C R F all directl y  o bser ve d a n d all s p o nta ne o usl y re p orte d 
A Es a n d S A Es re p orte d b y  t he partici pa nt.
As part of o n g oi n g safet y re vie ws c o n d ucte d b y t he s p o ns or, a n y n o nseri o us A E t hat is 
deter mi ne d b y t he s p o ns or t o be seri o us will be re p orte d b y t he s p o ns or as a n S A E. T o assist 
i n t he deter mi nati o n of case seri o us ness, f urt her i nf or mati o n ma y  be re q ueste d fr o m t he 
i n vesti gat or t o pr o vi de clarit y a n d u n dersta n di n g of t he e ve nt i n t he c o nte xt of t he cli nical 
st u d y.
If a partici pa nt be gi ns a ne w a ntica ncer t hera py, t he rec or di n g peri o d f or n o nseri o us A Es 
e n ds at t he ti me t he ne w treat me nt is starte d; h o we ver, S A Es m ust c o nti n ue t o be rec or de d o n 
t he C R F d uri n g t he a b o ve-i n dicate d acti ve c ollecti o n peri o d. N ote t hat a s witc h t o a 
c o m merciall y a vaila ble versi o n of t he st u d y i nter ve nti o n is c o nsi dere d as a ne w a n tica ncer 
t hera py f or t he p ur p oses of S A E re p orti n g.
8. 4. 2. Met h o d of Detecti n g A Es a n d S A Es
T he met h o d of rec or di n g, e val uati n g, a n d assessi n g ca usalit y  of A Es a n d S A Es a n d t he 
pr oce d ures f or c o m pleti n g a n d tra ns mitti n g S A E re p orts are pr o vi de d i n A p pe n di x 3 .
Care will be ta ke n n ot t o i ntr o d uce bias w he n detecti n g A Es a n d/ or S A Es. O pe n -e n de d a n d 
n o nlea di n g ver bal q uesti o ni n g of t he partici pa nt is t he preferre d met h o d t o i n q uire a b o ut 
A E occ urre nces.
8. 4. 3. F oll o w -U p of A Es a n d S A Es
After t he i nitial A E or S A E re p ort, t he i n vesti gat or is re q uire d t o pr oacti vel y  f oll o w eac h 
partici pa nt at s u bse q ue nt visits/c o ntacts. F or eac h e ve nt, t he i n vesti gat or m ust p urs ue a n d 
o btai n a de q uate i nf or mati o n u ntil res ol uti o n, sta bilizati o n, t he e ve nt is ot her wise e x plai ne d, 
or t he partici pa nt is l ost t o f oll o w- u p (as defi ne d i n Secti o n 7. 3 ).
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 7
I n ge neral, f oll o w- u p i nf or mati o n will i ncl u de a descri pti o n of t he e ve nt i n s ufficie nt detail t o 
all o w f or a c o m plete me dical assess me nt of t he case a n d i n de pe n de nt deter mi nati o n of 
p ossi ble ca usalit y . A ny i nf or mati o n rele va nt t o t he e ve nt, s uc h as c o nc o mita nt me dicati o ns 
an d ill nesses, m ust be pr o vi de d. I n t he case of a partici pa nt deat h, a s u m mar y  of a vaila ble 
a ut o ps y fi n di n gs m ust be s u b mitte d as s o o n as p ossi ble t o Pfizer Safet y. 
F urt her i nf or mati o n o n f oll o w -u p pr oce d ures is pr o vi de d i n A p pe n di x 3 .
8. 4. 4. Re g ul at or y Re p orti n g Re q uire me nts f or S A Es
Pr o m pt n otificati o n b y  t he i n vesti gat or t o t he s p o ns or of a n S A E is esse ntial s o t hat le gal 
o bli gati o ns a n d et hical res p o nsi bilities t o war d t he safet y of partici pa nts a n d t he safet y of a 
st u d y i nter ve nti o n u n der cli nical i n vesti gati o n are met.
T he s p o ns or has a le gal res p o nsi bilit y  t o n otif y b ot h t he l ocal re g ulat or y a ut h orit y a n d ot her 
re g ulat or y a ge ncies a b o ut t he safety of a st u d y i nter ve nti o n u n der cli nical i n vesti gati o n. T he 
s p o ns or will c om pl y  wit h c o u ntr y-s pecific re g ulat or y re q uire me nts relati n g t o safety 
re p orti n g t o t he re g ulat or y a ut h ority, I RBs/ E Cs , a n d i n vesti gat ors.
I n vesti gat or safet y re p orts m ust be pre pare d f or S U S A Rs acc or di n g t o l ocal re g ulat or y 
re q uire me nts a n d s p o ns or p olic y a n d f or war de d t o i n vesti gat ors as necessar y.
A n i n vesti gat or w h o recei ves S U S A Rs or ot her s pecific safet y i nf or mati o n (e g, s u m mar y or 
listi n g of S A Es) fr o m t he s p o ns or will re vie w a n d t he n file it al o n g wit h t he S R S D(s) f or t he 
st u d y a n d will n otif y t he I RB/ E C, if a p pr o priate acc or di n g t o l ocal re q uire me nts.
8. 4. 5. E n vir o n me nt al E x p os ure, E x p os ure D uri n g Pre g n a nc y or Bre astfee di n g, a n d 
Occ u p ati o n al E x p os ure
E n vir o n me ntal e x p os ure occ urs w he n a pers o n n ot e nr olle d i n t he st u d y as a partici pa nt 
recei ves u n pla n ne d direct c o ntact wit h or e x p os ure t o t he st u d y  i nter ve nti o n. S uc h e x p os ure 
ma y  or ma y n ot lea d t o t he occ urre nce of a n A E or S A E. Pers o ns at ris k f or e n vir o n me ntal 
e x p os ure i ncl u de healt hcare pr o vi ders, fa mil y me m bers, a n d ot hers w h o ma y be e x p ose d. A n 
e n viro n me ntal e x p os ure ma y  i ncl u de E D P, E D B, a n d occ u pati o nal e x p os ure.
A n y  s uc h e x p os ure t o t he st u d y i nter ve nti o n u n der st u d y are re p orta ble t o Pfizer Safety 
wit hi n 2 4 h o urs of i n vesti gat or a ware ness.
8. 4. 5. 1. E x p os ure D uri n g Pre g n a nc y
A n E D P occ urs if: 

A fe male part ici pa nt is f o u n d t o be pre g na nt w hile recei vi n g or after disc o nti n ui n g 
st u d y i nter ve nti o n.

A male partici pa nt w h o is recei vi n g or has disc o nti n ue d st u d y  i nter ve nti o n 
i nse mi nates a fe male part ner pri or t o or ar o u n d t he ti me of c o nce pti o n.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 8

A fe male n o n partic i pa nt is f o u n d t o be pre g na nt w hile bei n g e x p ose d or ha vi n g bee n 
e x p ose d t o st u d y i nter ve nti o n beca use of e n vir o n me ntal e x p os ure. Bel o w are 
e xa m ples of e n vir o n me ntal E D P:
o
A fe male fa mil y  me m ber or healt hcare pr o vi der re p orts t hat s he is pre g na nt after 
ha vi n g bee n e x p ose d t o t he st u d y  i nter ve nti o n b y i n gesti o n, i n halati o n, or s ki n 
c o ntact.
o
A male fa mil y me m ber or healt hcare pr o vi der w h o has bee n e x p ose d t o t he st u d y 
i nter ve nti o n b y i n gesti o n, i n halati o n, or s ki n c o ntact t he n i nse mi nates his fe male 
part ner pr i or t o or ar o u n d t he ti me of c o nce pti o n.
T he i n vesti gat or m ust re p ort E D P t o Pfizer Safet y wit hi n 2 4 h o urs of t he i n vesti gat or’s 
a ware ness, irres pecti ve of w het her a n S A E has occ urre d. T he i nitial i nf or mati o n s u b mitte d 
s h o ul d i ncl u de t he a ntici pate d date of deli ver y (see bel o w f or i nf or mati o n relate d t o 
ter mi nati o n of pre g na nc y). 

If E D P occ urs i n a partici pa nt/ partici pa nt’s part ner, t he i n vesti gat or m ust re p ort t his 
i nf or mati o n t o Pfizer Safet y  o n t he C T S A E Re p ort F or m a n d a n E D P S u p ple me ntal 
F or m, re gar d less of w het her a n S A E has occ urre d. Details of t he pre g na nc y will be 
c ollecte d after t he start of st u d y  i nter ve nti o n a n d u ntil 4 5 da ys after t he last d ose of 
P F -0 7 9 0 1 8 0 1 a n d 9 0 da ys after t he last d ose of tafasita ma b or 2 8 da y s after t he last 
d ose of le na li d o mi de. 

If E D P occ urs i n t he setti n g of e n vir o n me ntal e x p os ure, t he i n vesti gat or m ust re p ort 
i nf or mati o n t o Pfizer Safet y usi n g t he C T S A E Re p ort F or m a n d E D P S u p ple me ntal 
F or m . Si nce t he e x p os ure i nf or mati o n d oes n ot pertai n t o t he partici pa nt e nr olle d i n 
t he st u d y, t he i nf or mati o n is n ot rec or de d o n a C R F; h o we ver, a c o p y of t he 
c o m plete d C T S A E Re p ort F or m is mai ntai ne d i n t he i n vesti gat or site file.
F oll o w -u p is c o n d ucte d t o o btai n ge neral i nf or mati o n o n t he pre g na nc y  a n d its o utc o me f or 
all E D P re p o rts wit h a n u n k n o w n o utc o me. T he i n vesti gat or will f oll o w t he pre g na nc y u ntil 
c o m pleti o n ( or u ntil pre g na nc y  ter mi nati o n) a n d n otif y Pfizer Safety of t he o utc o me as a 
f oll o w-u p t o t he i nitial E D P S u p ple me ntal F or m. I n t he case of a li ve birt h, t he str uct ur al 
i nte grity of t he ne o nate ca n be assesse d at t he ti me of birt h. I n t he e ve nt of a ter mi nati o n, t he 
reas o n(s) f or ter mi nati o n s h o ul d be s pecifie d a n d, if cli nicall y p ossi ble, t he str uct ural 
i nte grity of t he ter mi nate d fet us s h o ul d be assesse d b y gr oss vis ual i ns pecti o n ( u nless 
pre -pr oce d ure test fi n di n gs are c o ncl usi ve f or a c o n ge nital a n o mal y a n d t he fi n di n gs are 
re p orte d).
A b n or mal pre g na nc y  o utc o mes are c o nsi dere d S A Es. If t he o utc o me of t he pre g na nc y meets 
t he criteria f or a n S A E (ie, ect o pic pre g na nc y, s p o nta ne o us a b orti o n, i ntra uteri ne fetal 
de mise, ne o natal deat h, or c o n ge nital a n o mal y i n a li ve-b or n ba b y, a ter mi nate d fet us, or a n 
i ntra uteri ne fetal de mise, or a ne o natal deat h), t he i n vesti gat or s h o ul d f oll o w t he pr oce d ures 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 9
f or re p orti n g S A Es. A d diti o nal i nf or mati o n a b o ut pre g na nc y o utc o mes t hat are re p orte d t o 
Pfizer Safet y  as S A Es f oll o ws: 

S p o nta ne o us a b orti o n i ncl u di n g miscarria ge a n d misse d a b orti o n s h o ul d be re p orte d 
as a n S A E;

Ne o natal deat hs t hat occ ur wit hi n 1 m o nt h of birt h s h o ul d be re p ort e d, wit h o ut re gar d 
t o ca usalit y, as S A Es. I n a d diti o n, i nfa nt deat hs after 1 m o nt h s h o ul d be re p orte d as 
S A Es w he n t he i n vesti gat or assesses t he i nfa nt deat h as relate d or p ossi bl y  relate d t o 
e x p os ure t o t he st u d y i nter ve nti o n. 
A d diti o nal i nf or mati o n re ga r di n g t he E D P ma y be re q ueste d b y t he s p o ns or. F urt her 
f oll o w- u p of birt h o utc o mes will be ha n dle d o n a case-b y -case basis (e g, f oll o w- u p o n 
preter m i nfa nts t o i de ntif y de vel o p me ntal dela y s). In t he case of pater nal e x p os ure, t he 
i n vesti gat or will pr o vi de t he partici pa nt wit h t he Pre g na nt Part ner Release of I nf or mati o n 
F or m t o deli ver t o his part ner. T he i n vesti gat or m ust d oc u me nt i n t he s o urce d oc u me nts t hat 
t he partici pa nt was gi ve n t he Pre g na nt Part ner Release of I nf or mati o n F or m t o pr o vi de t o his 
part ne r.
8. 4. 5. 2. E x p os ure D uri n g Bre astfee di n g
A n E D B occ urs if:

A fe male partici pa nt is f o u n d t o be breastfee di n g w hile recei vi n g or after 
disc o nti n ui n g st u d y  i nter ve nti o n.

A fe male n o n partici pa nt is f o u n d t o be breastfee di n g w hile bei n g e x p ose d or ha vi n g 
bee n e x p ose d t o st u d y  i nter ve nti o n (ie, e n vir o n me ntal e x p os ure). A n e xa m ple of 
e n vir o n me ntal E D B is a fe male fa mil y me m ber or healt hcare pr o vi der w h o re p orts 
t hat s he is breastfee di n g after ha vi n g bee n e x p ose d t o t he st u d y  i nter ve nti o n b y 
i n gesti o n, i n halati o n, or s ki n c o ntact. 
T he i n vesti gat or m ust re p ort E D B t o Pfizer Safet y wit hi n 2 4 h o urs of t he i n vesti gat or’s 
a ware ness, irres pecti ve of w het her a n S A E has occ urre d. T he i nf or mati o n m ust be re p orte d 
usi n g t he C T S A E Re p ort F or m. W he n E D B occ urs i n t he setti n g of e n vir o n me ntal e x p os ure, 
t he e x p os ure i nf or mati o n d oes n ot pertai n t o t he partici pa nt e nr olle d i n t he st u d y, s o t he 
i nf or mati o n is n ot rec or de d o n a C R F. H o we ver, a c o p y of t he c o m plete d C T S A E Re p ort 
F or m is mai ntai ne d i n t he i n vesti gat or site file.
A n E D B re p ort is n ot create d w he n a Pfizer dr u g s pecificall y a p pr o ve d f or use i n 
breastfee di n g w o me n (e g, vita mi ns) is a d mi nistere d i n acc or da nce wit h a ut h orize d use. 
H o w e ver, if t he i nfa nt e x perie nces a n S A E ass ociate d wit h s uc h a dr u g, t he S A E is re p orte d 
t o get her wit h t he E D B.
8. 4. 5. 3. Occ u p ati o n al E x p os ure
T he i n vesti gat or m ust re p ort a n y  i nsta nce of occ u pati o nal e x p os ure t o Pfizer Safety wit hi n 
2 4 h o urs of t he i n vesti gat or’s a ware ness usi n g t he C T S A E Re p ort F or m re gar dless of 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 0
w het her t here is a n ass ociate d S A E. Si nce t he i nf or mati o n a b o ut t he occ u pati o nal e x p os ure 
d oes n ot pertai n t o a partici pa nt e nr olle d i n t he st u d y , t he i nf or mati o n is n ot rec or de d o n a 
C R F; h o we ver, a c o p y of t he c o m plete d C T S A E Re p ort F or m m ust be mai ntai ne d i n t he 
i n vesti gat or site file.
8. 4. 6. C ar di o v asc ul ar a n d De at h E ve nts
N ot a p plica ble.
8. 4. 7. Dise ase -Rel ate d E ve nts a n d/ or Dise ase -Rel ate d O utc o mes N ot Q u alif yi n g as A Es 
or S A Es
N ot a p plica ble. 
8. 4. 8. A d verse E ve nts of S peci al I nterest
N ot a p plica ble.
8. 4. 8. 1. L ac k of Effic ac y
T he i n vesti gat or m ust re p ort si g ns, s y m pt o ms, a n d/ or cli nical se q uelae res ulti n g fr o m lac k of 
efficac y. Lac k of efficac y or fail ure of e x pecte d p har mac ol o gical acti o n is re p orta ble t o 
Pfizer Safet y  o nl y if a ss oci ate d wit h a n S A E. 
8. 4. 9.
Me dic al De vice Deficie ncies 
N ot a p plica ble.
8. 4. 1 0. Me dic ati o n Err ors
Me dicati o n err ors ma y  res ult fr o m t he a d mi nistrati o n or c o ns u m pti o n of t he st u d y 
i nter ve nti o n(s) b y t he wr o n g partici pa nt, or at t he wr o n g ti me, or at t he wr o n g d osa ge 
stre n gt h. 
Me dicati o n err ors are rec or de d a n d re p orte d as f oll o ws:
Rec or de d o n t he 
Me di c ati o n Err or 
P a ge of t he C R F
Rec or de d o n t he A E 
P a ge of t he C R F
Re p orte d o n t he C T S A E Re p ort 
F or m t o Pfizer S afet y Wit hi n 2 4 
H o urs of A w are ness
All (re gar dless of 
w het her ass ociate d wit h 
a n A E)
A n y  A E or S A E 
ass ociate d wit h t he 
me dicati o n err or
O nl y  if ass ociate d wit h a n S A E
Me dicati o n err ors i ncl u de:

Me dicati o n err ors i n v ol vi n g partici pa nt e x p os ure t o t he st u d y  i nter ve nti o n;
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 1

P ote ntial me dicati o n err ors or uses o utsi de of w hat is f oresee n i n t he pr ot oc ol t hat d o 
or d o n ot i n v ol ve t he st u d y  partici pa nt;

T he a d mi nistrati o n of e x pire d st u d y  i nter ve nti o n;

T he a d mi nistrati o n of a n i nc orrect st u d y  i nter ve nti o n;

T he a d mi nistrati o n of a n i nc orrect d osa ge ( ± 2 0 %); 

Fail ure t o m o dif y  d ose as re q uire d per pr ot oc ol f or t o xicit y ma na ge me nt (i nterr u pti o n 
or d ose re d ucti o n or disc o nti n uati o n);

T he a d mi nistrati o n of st u d y  i nter ve nti o n t hat has u n der g o ne te m perat ure e xc ursi o n 
fr o m t he s pecifie d st ora ge ra n ge, u nless it is deter mi ne d b y t he s p o ns or t hat t he st u d y 
i nter ve nti o n u n der q uesti o n is acce pta ble f or use.
S uc h me dicati o n err ors occ urri n g t o a st u d y partici pa nt are t o be ca pt ure d o n t he me dicati o n 
err or pa ge of t he C R F, w hic h is a s pecific versi o n of t he A E pa ge.
W het her or n ot t he me dicati o n err or is acc o m pa nie d b y  a n A E, as deter mi ne d b y  t he 
i n vesti gat or, t he me dicati o n err or is rec or de d o n t he me dicati o n err or pa ge of t he C R F a n d, if 
a p plica ble, a n y ass ociate d A E(s), seri o us a n d n o nseri o us, are rec or de d o n t he A E pa ge of t he 
C R F . 
I n t he e ve nt of a me dicati o n d osi n g err or, t he s p o ns or s h o ul d be n otifie d wit hi n 2 4 h o urs.
Me dicati o n err ors s h o ul d be re p orte d t o Pfizer Safet y wit hi n 2 4
h o urs o n a C T S A E Re p ort 
F or m o nl y w he n ass oci ate d wit h a n S A E.
8. 5. P h ar m ac o ki netics 
Bl o o d sa m ples f or t he P K a nal ys is of P F-0 7 9 0 1 8 0 1, tafasita ma b a n d le nali d o mi de 
c o nce ntrati o ns will be c ollecte d i nt o a p pr o priatel y la bele d t u bes at t he ti mes s pecifie d i n t he 
S o A . F or eac h ti me p oi nt, bl o o d sa m ples will be c ollecte d f or meas ure me nt of c o nce ntrati o ns 
of P F -0 7 9 0 1 8 0 1, tafasita ma b a n d le nali d o mi de, res pecti vel y . Instr ucti o ns f or t he c ollecti o n 
a n d ha n dli n g of bi ol o gical sa m ples are pr o vi de d i n t he La b orat or y  Ma n ual or b y  t he s p o ns or. 
All eff orts will be ma de t o o btai n t he sa m ples at t he e xact n o mi nal ti me relati ve t o d osi n g. 
C ollecti o n of sa m ples wit hi n t he sa m pli n g ti me wi n d o w s pecifie d i n t he S o A will n ot be 
ca pt ure d as a pr ot oc ol de viati o n. T he act ual date a n d ti me ( 2 4 h o ur cl oc k ti me) of P K sa m ple 
c ollecti o n as well as t he date a n d ti me of t he last d ose pri or t o P K sa m ple c ollecti o n f or eac h 
sa m ple will be rec or de d i n t he C R F.
If p ossi ble, bl o o d f or P K s h o ul d be dra w n fr o m a peri p heral vei n or fr o m t he l u me n of a 
ce ntral ve n o us cat heter t hat is n ot use d f or i nf usi o n of P F- 0 7 9 0 1 8 0 1 or tafasita ma b.
Sa m ples c ollecte d f or meas ure me nt of st u d y i nter ve nti o n c o nce ntrati o ns will be a nal yz e d 
usi n g vali date d a nal yt ical met h o ds i n c o m plia nce wit h a p plicable S O Ps.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 2
Sa m ples c ollecte d f or a nal y ses of st u d y i nter ve nti o n c o nce ntrati o n ma y als o be use d t o 
e val uate safet y or efficac y as pects relate d t o c o ncer ns arisi n g d uri n g or after t he st u d y or 
e val uati o n of t he bi oa nal ytical met h o d. T hese data will be use d f o r i nter nal e x pl orat or y 
p ur p oses a n d n ot re p orte d i n t he C S R.
T he P K sa m ples m ust be pr ocesse d a n d s hi p pe d as i n dicate d i n t he i nstr ucti o ns pr o vi de d t o 
t he i n vesti gat or site t o mai ntai n sa m ple i nte grit y. A n y de viati o ns fr o m t he P K sa m ple 
ha n dli n g pr oce d ure (e g, sa m ple c ollecti o n a n d pr ocessi n g ste ps, i nteri m st ora ge or s hi p pi n g 
c o n diti o ns), i ncl u di n g a n y acti o ns ta ke n, m ust be d oc u me nte d a n d re p orte d t o t he s p o ns or. 
O n a case b y case basis, t he s p o ns or ma y  ma ke a deter mi nati o n as t o w het her sa m ple 
i nte grity has bee n c o m pr o mise d.
8. 6. Ge netics
8. 6. 1. S pecifie d Ge netics
S pecifie d ge netic a nal ys es (  
D N A
 ma y be perf or me d t o e val uate t he 
relati o ns hi p bet wee n patie nt o utc o mes or A Es, a n d variati o ns at s pecific ge netic l oci (s uc h as 
ge nes). H o we ver, a na l ysis of ge netic pre dis p ositi o n t o disease will n ot be perf or me d 
i n t his st u d y a n d t he se q ue nci n g met h o ds will n ot ha ve bee n vali date d f or dia g n ostic use.
Please refer t o Secti o n 8. 7. 5 a n d Secti o n 8. 7. 6 .
8. 6. 2. Ret ai ne d Rese arc h S a m ples f or Ge netics
A 4 -m L  bl o o d sa m ple o pti mize d f or D N A
Pre p D 1 will be c ollecte d acc or di n g t o 
t he S o A , as l ocal re g ulati o ns a n d IR Bs/ E C s all o w. 
Retai ne d Researc h Sa m ples ma y  be use d f or researc h relate d t o t he st u d y i nter ve nti o n(s) a n d 
D L B C L . Ge nes a n d ot her a nalyt es (e g, pr otei ns, R N A, n o n dr u g meta b olites) ma y  be st u die d 
usi n g t he ba n ke d sa m ples. 
See A p pe n di x 5 f or i nf or mati o n re gar di n g ge netic researc h. Details o n pr ocesses f or 
c ollecti o n a n d s hi pme nt of t hese sa m ples ca n be f o u n d i n t he L a b orat or y Ma n ual.
8. 7. Bi o m ar kers
U nless pr o hi bite d b y  l ocal re g ulati o ns or et hics c o m mittee decisi o n, bi os peci me ns will be 
c ollecte d t o a nal yz e 
f or ac hie vi n g st u d y 
o bjecti ves. S pecific a nal y ses ma y n ot be perf or me d if e mer gi n g data i n dicate t hat th e y  w o ul d 
n o l o n ger s u p p ort st u d y  o bjecti ves. Details re gar di n g t he ty pes of bi os peci me n a n d p ur p oses 
of c ollecti o n are liste d bel o w. Refer t o t he S o A f or sa m ple c ollecti o n ti me p oi nts ( n ote: 
pre -d ose sa m ples are t o be c ollecte d bef o re a ny pre -me dicati o n or st u d y i nter ve nti o n o n 
i n dicate d visits) a n d La b orat or y Ma n ual f or sa m ple c ollecti o n, pr ocessi n g a n d s hi p pi n g.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 3
T he f oll o wi n g sa m ples f or bi o mar ker researc h are re q uire d a n d will be c ollecte d fr o m all 
partici pa nts i n t his st u d y  as s pecifie d i n t he S o A :

Bl o o d sa m ples at desi g nate d ti me p oi nts t o be pr ocesse d i nt o ser u m f or circ ulati n g 
bi o mar ker a nal ys is;

W h ole bl o o d sa m ples at desi g nate d ti me p oi nts f or meas ure me nt of C D 4 7 rece pt or 
occ u pa nc y ,
a n d s pecifie d ge netic researc h;

sa m ples at C 1 D 1 as matc he d c o ntr ol f or filteri n g s o matic m utati o n data a n d f or 
s pecifie d ge netic researc h;

Bl o o d sa m ples at desi g nate d ti me p oi nts t o be pr ocesse d i nt o plas ma f or assess me nt of 
;

Ba seli ne pre-treat me nt t u m or tiss ue sa m ples t o e na ble ge netic a n d bi o mar ker 
a nal ys es.
O pti o nal sa m ples f or bi o mar ker researc h t hat s h o ul d be c ollecte d fr o m partici pa nts i n t he 
st u d y as a p pr o priate are t he f oll o wi n g:

T u m or tiss ue sa m ples c ollecte d at rela pse /P D or E O T are str o n gl y rec o m me n de d; 
t u m or tiss ue sa m ples c ollecte d at ot her disease assess me nts if cli nicall y i n dicate d. 
T hese sa m ples will be use d t o e na ble ge netic a n d bi o mar ker a nal ys es.
8. 7. 1. Bl o o d S a m ple f or Circ ul ati n g Bi o m ar ker A n al ysis
A bl o o d sa m ple will be c ollecte d at ti me p oi nts a n d pr ocesse d i nt o ser u m sa m ple s pecifie d i n 
t he S o A . T his sa m ple ma y be use d f or circ ulati n g bi o mar ker a nalys is, w hic h ma y i ncl u de 
 a n d/ or ot her 
a nal ys is.
8. 7. 2. Bl o o d S a m ple f or C D 4 7 Rece pt or Occ u p a nc y A n al ysis
A w h ole bl o o d sa m ple will be c ollecte d at ti me p oi nts s pecifie d i n t he S o A . T his sa m ple ma y 
be use d t o assess peri p heral C D 4 7 rece pt or occ u pa nc y  a n d distri b uti o n of vari o us bl o o d cell 
p o p ulati o ns b y  fl o w c yt o metr y. 
8. 7. 3. Bl o o d S a m ple f or
A w h ole bl o o d sa m ple will be c ollecte d at ti me p oi nts s pecifie d i n t he S o A . T his sa m ple ma y 
be use d t o assess t he
a n d p har mac o d yna mics of t he peri p heral bl o o d  
 
 
8. 7. 4. Bl o o d S a m ple f or
A w h ole bl o o d sa m ple will be c ollecte d at ti me p oi nts s pecifie d i n t he S o A . T his sa m ple ma y 
be use d t o e xa mi ne t he 
b y  
a nal ys is a n d/ or
 a n d/ or s pecialize d 
a p pr oac hes).
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 4
8. 7. 5. Bl o o d S a m ple f or S pecifie d Ge netic Rese arc h
A w h ole bl o o d sa m ple will be c ollecte d fr o m all partici pa nts o n C 1 D 1 at pre -d ose. T his 
sa m ple ma y be use d t o c o nfir m s o matic vs ger mli ne ori gi n of alter nati o ns i n t u m or D N A or 
 T he sa m ple ma y als o be use d t o e val uate t he relati o ns hi p bet wee n patie nt o utc o mes 
or A Es, a n d variati o ns at s pecifi c l oci (s uc h as  
 ge nes), or 
of 
D N A. 
8. 7. 6.
S a m ple f or M atc he d C o ntr ol a n d S pecifie d Ge netic Rese arc h
 sa m ples will be c ollecte d fr o m all partici pa nts o n C 1 D 1 at pre d ose. T his sa m ple ma y 
be use d t o c o nfir m s o matic vs ger mli ne ori gi n of D N A alterati o ns i n t u m or D N A or 
 
. T he sa m ple ma y als o be use d t o e val uate t he relati o ns hi p bet wee n cli nical o utc o mes or 
A Es, a n d variati o ns at s pecific l oci (s uc h as 
ge nes), or 
of 
D N A.
8. 7. 7. Bl o o d S a m ple f or
 A n al ysis
A bl o o d sa m ple f or  
a nal ys es will be c ollecte d at ti me p oi nts a n d pr ocesse d i nt o 
plas ma s pecifie d i n t he S o A . T his sa m ple ma y be use d t o assess ge netic c ha n ges i n  
 t o 
e val uate 
 (as assesse d by
) wit h res p o nse t o st u d y 
treat me nt, p ote ntiall y e x pl ore c orrelati o ns wit h t u m or
a n d t o u n dersta n d 
p ote ntial mec ha nis ms of ac q uire d resista nce t o st u d y  treat me nt. A
ma y be use d f or t hese a nal yses. E x pl orat or y
a n d/ or 
 a nal yses ma y be perf or me d. 
8. 7. 8. T u m or Tiss ue f or Ge netic/ Bi o m ar ker A n al ysis 
T u m or bi os peci me ns fr o m arc hi val a n d/ or de n o v o bi o psies c ollecte d at Scree ni n g a n d/ or 
o n- treat me nt ti me p oi nts ma y be use d t o a nalyz e ca n di date n ucleic aci d a n d pr otei n 
bi o mar kers, or rele va nt si g nat ure of mar kers, f or t heir a bilit y  t o i de ntif y t h ose partici pa nts 
w h o are m ost li kel y t o be nefit fr o m treat me nt wit h t he st u d y dr u gs. Bi o mar kers ma y i ncl u de, 
b ut are n ot li mite d t o 
a nal ys es, as well as 
a n d 
of t he t u m or micr oe n vir o n me nt. 
 a n d/ or 
a nal ys is, w hic h 
ma y  i ncl u de 
a n d/ or
a n d/ or 
a n d/ or 
a nal yses, ma y be perf or me d t o e xa mi ne
 c orrelati o ns bet wee n ge ne m utati o n stat us or
 si g nat ures a n d 
cli nical o utc o me. As sa m ples ma y be c ollecte d w hile partici pa nts are o n treat me nt, t hese 
a nal ys es ma y als o defi ne t he p har mac o dy n a mics of P F-0 7 9 0 1 8 0 1 a n d/ or c o m bi nati o n 
m olec ules(s) or i de ntif y  bi o mar kers t hat c orrelate wit h a n d p ote ntiall y defi ne mec ha nis ms of 
resista nce a n d rela pse. 
T u m or bi os peci me ns c ollecte d d uri n g Sc ree ni n g ma y be use d f or e val uati o n of 
e x pressi o n f or t he partici pa nts wit h 
 I n a d diti o n, sa m ples fr o m all 
teste d partici pa nts ma y be use d t o hel p s u p p ort de vel o p me nt of a p ote ntial t u m or tiss ue 
dia g n ostic test.
Ne wl y ac q uire d F F P E/ N B F t u m or tiss ue o btai ne d at Scree ni n g Visit ( prefera bl y  t u m or bl oc k; 
if n ot, u nstai ne d sli des are als o acce pta ble) will be s u b mitte d f or ge netic/ bi o mar k er a nal ys is. 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 5
Arc hi val tiss ue is acce pta ble o nl y  if tiss ue at Scree ni n g Visit is n ot a vaila ble, a n d t he baseli ne
tiss ue c h ose n s h o ul d be t he m ost rece ntly c ollecte d s peci me n bef ore t he start of t he st u d y  
t hera py a n d after t he m ost rece nt s ys te mic t hera p y.
F or ce ntral
testi n g (f or partici pa nts e x p ose d t o pri or
, see 
i ncl usi o n criteri o n # ), a t u m or bl oc k is s ufficie nt f or b ot h 
 test a n d ge netic/ bi o mar ker 
a nal ys is. If sli des are pr o vi de d, a d diti o nal t u m or tiss ue sli des will be re q uire d f or
e x pressi o n assess me nt i n a d diti o n t o w hat is nee de d f or ge netic/ bi o mar ker a nal ys is (see 
la b orat or y ma n ual f or details).
F urt her m ore, if t he partici pa nt u n der g oes t u m or bi o ps y  or resecti o n as part of cli nical care at 
a n y ti me d uri n g t he treat me nt peri o d, e ver y eff ort s h o ul d be ta ke n t o s u b mit a p orti o n of t he 
t u m or tiss ue f or st u d y p ur p oses. E ver y  eff ort s h o ul d be ma de t o o btai n t u m or tiss ue at 
rela pse/ P D/ E O T e xce pt i n i nsta nces w here t he pr oce d ure, as perf or me d i n t he cli nical 
researc h setti n g, p oses a n u nacce pta ble ris k t o t he partici pa nt. T o li mit i nterfere nce wit h 
disease assess me nts, f or o n-treat me nt t u m or bi o psies t hat are ta ke n after baseli ne a n d pri or t o 
E O T, ne w lesi o ns are t o be selecte d w he n feasi ble ( pr o vi di n g t here is n o i m pact o n cli nical 
care).
O nl y  c ore nee dle bi o psies, e xcisi o nal bi o psies, or resecti o n s peci me ns are s uita ble. C y t ol o gic 
pre parati o ns, s uc h as fi ne nee dle as pirate bi o psies, are n ot acce pta ble. T u m or bi os peci me ns 
s h o ul d be s u b mitte d i n t he f or m of a F F P E t u m or bl oc k. If F F P E tiss ue bl oc ks ca n n ot be 
pr o vi de d, t he tiss ue s h o ul d be s u b mitte d as F F P E tiss ue secti o ns t h at are fres hl y c ut 
( preferre d t o be c ut n o m ore t ha n 3 0 da ys pri or t o s hi p me nt t o t he ce ntral la b). A d diti o nal 
i nf or mati o n o n tiss ue c ollecti o n pr oce d ures a n d sa m ple re q uire me nts ca n be f o u n d i n t he 
La b orat or y  Ma n ual.
8. 8. I m m u n o ge nicit y Assess me nts
8. 8. 1. A nti -P F - 0 7 90 1 8 0 1 A nti b o d y ( A D A) a n d Ne utr alizi n g A nti -P F -0 7 9 0 1 8 0 1 A nti b o d y 
( N A b)
Bl o o d sa m ples will be c ollecte d f or deter mi nati o n of A D A a n d N A b f or P F -0 7 9 0 1 8 0 1 i nt o 
a p pr o priatel y la bele d t u bes at ti mes s pecifie d i n t he S o A . I nstr ucti o ns f or t he c ollecti o n a n d 
ha n dli n g of bi ol o gical sa m ples will be pr o vi de d i n t he La b orat or y  Ma n ual. T he act ual date 
a n d ti me ( 2 4- h o ur cl oc k ti me) of eac h sa m ple will be rec or de d.
Sa m ples c ollecte d f or deter mi nati o n of A D A a n d N A b will be a nal yz e d usi n g a vali date d 
a nal yt ical met h o d i n c o m plia nce wit h a p plica ble S O Ps. Sa m ples deter mi ne d t o be p ositi ve 
f or A D A ma y be f urt her c haracterize d f or N A b.
Sa m ples ma y  als o be use d f or a d diti o nal c haracterizati o n of t he i m m u ne res p o nse a n d/ or 
e val uati o n of t he bi oa nal ytical met h o d, or f or ot her i nter nal e x pl orat or y  p ur p oses. T hese data 
will be use d f or i nter nal e x pl orat or y  p ur p oses a n d n ot re p orte d i n t he C S R.
T he i m m u n o ge nicit y sa m ples m ust be pr ocesse d a n d s hi p pe d as i n dicate d i n t he i nstr ucti o ns 
pr o vi de d t o t he i n vesti gat or site t o mai ntai n sa m ple i nte grit y . A ny de viati o ns fr o m t he 
i m m u n o ge nicity sa m ple ha n dli n g pr oce d ure (e g, sa m ple c ollecti o n a n d pr ocessi n g ste ps, 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 6
i nteri m st ora ge, or s hi p pi n g c o n diti o ns), i ncl u di n g a n y acti o ns ta ke n, m ust be d oc u me nte d 
a n d re p orte d t o t h e s p o ns or. O n a case b y case basis, t he s p o ns or ma y ma ke a deter mi nati o n 
as t o w het her sa m ple i nte grit y has bee n c o m pr o mise d.
8. 8. 2. A nti -T af asit a m a b A nti b o d y ( A D A) a n d Ne utr alizi n g A nti -T af asit a m a b A nti b o d y 
( N A b)
Bl o o d sa m ples will be c ollecte d f or deter mi nati o n of A D A a n d N A b f or tafasita ma b i nt o 
a p pr o priatel y la bele d t u bes at ti mes s pecifie d i n t he S o A . I nstr ucti o ns f or t he c ollecti o n a n d 
ha n dli n g of bi ol o gical sa m ples will be pr o vi de d i n t he La b orat or y  Ma n ual. T he act ual date 
a n d ti me ( 2 4- h o ur cl oc k ti me) of eac h sa m ple will be rec or de d. 
Sa m ples c ollecte d f or deter mi nati o n of A D A a n d N A b will be a nal yz e d usi n g a vali date d 
a nal yt ical met h o d i n c o m plia nce wit h a p plica ble S O Ps. Sa m ples deter mi ne d t o be p ositi ve 
f or A D A ma y be f urt her c haracterize d f or N A b.
Sa m ples ma y  als o be use d f or a d diti o nal c haracterizati o n of t he i m m u ne res p o nse a n d/ or 
e val uati o n of t he bi oa nal ytical met h o d, or f or ot her i nter nal e x pl orat or y  p ur p oses. T hese data 
will be use d f or i nter nal e x pl orat or y  p ur p oses a n d n ot re p orte d i n t he C S R.
T he i m m u n o ge nicit y sa m ples m ust be pr ocesse d a n d s hi p pe d as i n dicate d i n t he i nstr ucti o ns 
pr o vi de d t o t he i n vesti gat or site t o mai ntai n sa m ple i nte grit y . A ny de viati o ns fr o m t he 
i m m u n o ge nicity sa m ple ha n dli n g pr oce d ure (e g, sa m ple c ollecti o n a n d pr ocessi n g ste ps, 
i nteri m st ora ge, or s hi p pi n g c o n diti o ns), i ncl u di n g a n y acti o ns ta ke n, m ust be d oc u me nte d 
a n d re p orte d t o t he S p o ns or. O n a case b y case basis, t he S p o ns or ma y m a ke a deter mi nati o n 
as t o w het her sa m ple i nte grit y has bee n c o m pr o mise d.
8. 9. P h ar m ac o d y n a mics
Bi o mar ker sa m ples ma y  be use d f or e x pl orat or y p har mac o dy n a mics a nal ys es (see 
Secti o n 8. 7 ).
As part of u n dersta n di n g t he p har mac o d y n a mics of t he i n vesti gati o nal pr o d ucts, sa m ples ma y  
be use d f or e val uati o n of t he bi oa nal yt ical met h o d, as well as f or ot her i nter nal e x pl orat or y 
p ur p o ses. T hese data ma y n ot be i ncl u de d i n t he C S R.
T he p har mac o d y na mic sa m ples m ust be pr ocesse d a n d s hi p pe d as i n dicate d i n t he 
i nstr ucti o ns pr o vi de d t o t he i n vesti gat or site t o mai ntai n sa m ple i nte grity. A n y de viati o ns 
fr o m t he p har mac o dy na mic sa m ple ha n dli n g pr oce d ures (e g, sa m ple c ollecti o n a n d 
pr ocessi n g ste ps, i nteri m st ora ge or s hi p pi n g c o n diti o ns), i ncl u di n g a n y  acti o ns ta ke n, m ust 
be d oc u me nte d a n d re p orte d t o t he s p o ns or. O n a case- b y -case basis, t he s p o ns or ma y  deci de 
w het her sa m ple i nte grit y  has bee n c o m pr o mise d.
9. S T A TI S TI C A L C O N SI D E R A TI O N S
Detaile d met h o d ol o g y  f or s u m mar y a n d statistical a nalys es of t he data c ollecte d i n t his st u d y  
is o utli ne d here a n d f urt her detaile d i n t he S A P, w hic h will be mai ntai ne d b y t he s p o ns or. 
T he S A P ma y  m o dif y w hat is outli ne d i n t he pr ot oc ol w here a p pr o priate; h o we ver, a n y  maj or 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 7
m o dificati o ns of t he pri mar y  e n d p oi nt defi niti o ns or t heir a nalys es will als o be reflecte d i n a 
pr ot oc ol a me n d me nt.
Per pr ot oc ol a me n d me nt , P hase 2 of t he st u d y will n ot be i nitiate d t heref ore the P hase 2 
e n d p oi nts will n ot be a nal yze d ( pr ot oc ol a me n d me nt 2).
9. 1. He alt h Ec o n o mics
Healt h ec o n o mics/ me dical res o urce utilizati o n a n d healt h ec o n o mics para meters are n ot 
e val uate d i n t his st u d y.
9. 2. St atistic al H y p ot hesis
T here is n o f or mal h y p ot hesis testi n g f or t he st u dy.
9. 2. 1. Pri m ar y Esti m a n ds
9. 2. 1. 1. P h ase 1 b Pri m ar y Esti m a n d
Pri m ar y Esti m a n d : D L T rate esti mate d base d o n data fr o m D L T-e val ua ble partici pa nts 
d uri n g t he D L T o bser vati o n peri o d ( 2 8 da y s f oll o wi n g C 1 D 1). T he esti ma n d has t he 
f oll o wi n g attri b utes:

P o p ulati o n: D L T -e val ua ble partici pa nts wit h R/ R D L B C L, as defi ne d b y  t he 
i ncl usi o n a n d e xcl usi o n criteria t o reflect t he tar gete d p o p ulati o n of t he treat me nt, 
w h o recei ve at least 1 d ose of t he st u d y i nter ve nti o n i n t he P hase 1 b of t he st u d y  a n d 
eit her e x perie nce D L T(s) d uri n g t he D L T o bser vati o n peri o d or c o m plete t he D L T 
o bser vati o n peri o d wit h o ut D L T. Partici pa nts wit h o ut D L Ts w h o recei ve less t ha n 
8 0 % of t he pla n ne d d ose of P F -0 7 9 0 1 8 0 1 or less t ha n 7 5 % of t he pla n ne d d ose of a n y  
c o m p o ne nt of t he tafasita ma b a n d le nali d o mi de re gi me n i n t he D L T o bser vati o n 
peri o d are n ot e val ua ble f or D L Ts.

Varia ble: Occ urre nce of D L Ts d uri n g t he D L T o bser vati o n peri o d.

I nterc urre nt e ve nt: T he data fr o m partici pa nts w h o are n ot D L T-e val ua ble will be 
e xcl u de d. Partici pa nts wit h o ut D L Ts w h o st o p pe d treat me nt bef ore recei vi n g at least 
8 0 % of t he pla n ne d d ose of P F -0 7 9 0 1 8 0 1 a n d at least 7 5 % of t he pla n ne d d ose of a n y  
c o m p o ne nt of t he tafasita ma b a n d le nali d o mi de re gi me n will be e xcl u de d.

P o p ulati o n -le vel s u m mar y meas ure: D L T rate defi ne d as t he n u m ber of 
D L T- e val ua ble partici pa nts wit h D LTs i n t he D L T o bser vati o n peri o d di vi de d b y  t he 
n u m ber of D L T -e val ua ble partici pa nts.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 8
9. 2. 1. 2. P h ase 2 Pri m ar y Esti m a n d
Pri m ar y Esti m a n d : T he treat me nt effect of P F-0 7 9 0 1 8 0 1 i n c o m bi nati o n wit h tafasita ma b 
a n d le nali d o mi de o n O R per t he L u ga n o 2 0 1 4 res p o nse criteria as deter mi ne d b y i n vesti gat or 
assess me nt. T he esti ma n d has t he f oll o wi n g attri b utes:

P o p ulati o n: R/ R D L B C L partici pa nts, as defi ne d b y  t he i ncl usi o n a n d e xcl usi o n 
criteria t o reflect t he tar gete d p o p ulati o n of t he treat me nt, w h o recei ve d at least 1 d ose 
of st u d y  i nter ve nti o n.

Varia ble: O bjecti ve res p o nse defi ne d as C R or P R per L u ga n o 2 0 1 4 res p o nse criteria 
as deter mi ne d b y i n vesti gat or, fr o m t he date of first d ose u ntil t he first d oc u me ntati o n 
of P D, dea t h, or start of ne w a ntica ncer t hera p y. 

I nterc urre nt e ve nts: All data c ollecte d after a n i nterc urre nt e ve nt of s u bse q ue nt 
a ntica ncer t hera p y will be e xcl u de d. All res p o nse assess me nts re gar dless of ga ps i n 
disease assess me nts will be c o nsi dere d. Partici pa nts w h o d o n ot ha ve a p ost -baseli ne 
disease assess me nt d ue t o earl y P D, w h o recei ve a ntica ncer t hera pies ot her t ha n t he 
st u d y i nter ve nti o n pri or t o ac hie vi n g a n o bjecti ve res p o nse, or w h o die, e x perie nce 
P D, or st o p disease assess me nts f or a n y reas o n pri or t o ac hie vi n g a n o bjecti ve 
res p o nse will be c o u nte d as n o n-res p o n ders. 

P o p ulati o n -le vel s u m mar y meas ure: O R R defi ne d as t he pr o p orti o n of partici pa nts i n 
t he a nalys is p o p ulati o n wit h a n o bjecti ve res p o nse, a n d 2-si de d 9 5 % CI f or O R R 
usi n g t he Wils o n met h o d. Res ults will be dis pla y e d b y treat me nt gr o u p.
9. 3. A n al ysis Sets
F or p ur p oses of a nal y sis, t he f oll o wi n g a nalys is sets are defi ne d. 
P artici p a nt A n al ysis Set
Descri pti o n
D L T E val ua ble Set 
All e nr olle d partici pa nts w h o recei ve at least 1 d ose of t he st u d y 
i nter ve nti o n i n t he P hase 1 b of t he st u d y a n d eit her e x perie nce D L T(s) 
or c o m plete t he D L T o bser vati o n peri o d wit h o ut D L T. Partici pa nts 
wit h o ut D L Ts w h o recei ve less t ha n 8 0 % of t he pla n ne d d ose of 
P F -0 7 9 0 1 8 0 1 or less t ha n 7 5 % of t he pla n ne d d ose of a n y c o m p o ne nt 
of t he tafasita ma b a n d le nali d o mi de re gi me n i n t he D L T o bser vati o n 
peri o d are n ot e val ua ble f or D L Ts.
T he D L T o bser vati o n peri o d is 2 8 da ys f oll o wi n g C 1 D 1.
Safet y A nal ysis Set
A ll e nr olle d partici pa nts w h o recei ve d at least 1 d ose of st u d y 
i nter venti o n. 
P K A nal ysis Set 
T he P K a nal ysis set will i ncl u de all partici pa nts i n t he safet y a nal ysis 
set w h o ha ve at least 1 p ost-d ose c o nce ntrati o n meas ure me nt.
T he P K para meter a nal ysis set will i ncl u de all partici pa nts i n t he safet y 
a nal ysis set w h o ha ve at least o ne of t he P K para meters of i nterest f or 
P F -0 7 9 0 1 8 0 1.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 9
P artici p a nt A n al ysis Set
Descri pti o n
I m m u n o ge nicit y A nal ysis 
Set
All partici pa nts i n t he safet y a nal ysis set w h o ha ve at least 1 sa m ple 
teste d f or A D A.
Bi o mar ker A nal ysis Set
All partici pa nts i n t he safet y a nal ysis set w h o ha ve at least 1 baseli ne 
bi o mar ker assess me nt.
A nal ysis sets will be defi ne d se paratel y f or bi o mar kers base d o n 
“ E nr olle d” mea ns a partici pa nt's, or t heir le gall y a ut h orize d re prese ntati ve’s, a gree me nt t o partici pate i n a 
cli nical st u d y f oll o wi n g c o m pleti o n of t he i nf or me d c o nse nt pr ocess a n d assi g n me nt t o st u d y i nter ve nti o n.
9. 4. St atistic al A n al yses
T he S A P will be de vel o pe d a n d fi nalize d bef ore a n y  a nalys es are perf or me d a n d will 
descri be t he a nal ys es a n d pr oce d ures f or a cc o u nti n g f or missi n g, u n use d, a n d s p uri o us data. 
T his secti o n is a s u m mar y of t he pla n ne d statistical a nal y ses of t he pri mar y a n d sec o n dar y 
e n d p oi nts.
9. 4. 1. Ge ner al C o nsi der ati o ns
All a nal y ses will be perf or me d f or t he P hase 1 b a n d P hase 2 of t he st u d y se paratel y. All 
efficac y a nalys es a n d safet y a nalys es will be perf or me d usi n g t he Safet y A nal ysis Set (if n ot 
ot her wise s pecifie d).
I n ge neral, descri pti ve s u m maries will be prese nte d f or t he efficac y a n d safet y varia bles 
c ollecte d. C o nti n u o us varia bles wi ll be s u m marize d usi n g mea n, S D, mi ni m u m, me dia n, a n d 
ma xi m u m. Cate g orical varia bles will be s u m marize d usi n g fre q ue nc y  c o u nts a n d 
perce nta ges.
U nless ot her wise s pecifie d, t he calc ulati o n of pr o p orti o ns will be base d o n t he sa m ple size of 
t he p o p ulati o n of i nterest. C o u nts of missi n g o bser vati o ns will be i ncl u de d i n t he 
de n o mi nat or a n d prese nte d as a se parate cate g or y  if n ot ot her wise s pecifie d i n t he S A P.
9. 4. 2. Pri m ar y E n d p oi nts/ A n al ysis
9. 4. 2. 1. P h ase 1 b
T he pri mar y  e n d p oi nt of t he P hase 1 b of t he st u d y is t he D LTs d uri n g t he D L T o bser vati o n 
peri o d. T he n u m ber a n d pr o p orti o n of partici pa nts e x perie nci n g D L Ts d uri n g t he D L T 
o bser vati o n peri o d will be s u m marize d a n d liste d b y  d ose le vel. A nalys es of D L Ts will be 
perf or me d o n D L T E val ua ble Set (as defi ne d i n Secti o n 9. 3 ). 
9. 4. 2. 2. P h ase 2
T he pri mar y  e n d p oi nt i n t he P hase 2 of t he st u d y is O R per L u ga n o Res p o nse Classificati o n 
Criteria 2 0 1 4 as assesse d b y  t he i n vesti gat or. 
O R is defi ne d as a B O R of C R or P R acc or di n g t o L u ga n o Res p o nse Classificati o n Criteria 
2 0 1 4.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)
C CI

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 0
Treate d partici pa nts w h o d o n ot ha ve a p ost - baseli ne t u m or assess me nt d ue t o early cli nical 
pr o gressi o n of disease, w h o recei ve a nti -ca ncer t hera pies ot her t ha n t he st u d y i nter ve nti o ns 
pri or t o reac hi n g a C R or P R, or w h o die, ha ve d oc u me nte d P D, or st o p t u m or assess me nts 
f or a ny reas o n pri or t o reac hi n g a C R or P R will be c o u nte d as n o n- res p o n ders i n t he 
assess me nt of O R. O R rate is t he pr o p orti o n of partici pa nts wit h O R i n t he safet y a nal ysis 
set. O R R will be calc ulate d al o n g wit h t he 2-si de d 9 5 % CI usi n g t he Wils o n met h o d.
9. 4. 3. Sec o n d ar y E n d p oi nts/ A n al ysis
9. 4. 3. 1. Ef fic ac y A n al yses
C o m plete Res p o nse 
C R rate is defi ne d as t he pr o p orti o n of partici pa nts i n t he Safet y  A nalys is Set wit h a C R per 
L u ga n o Res p o nse Classificati o n Criteria 2 0 1 4 as assesse d b y  t he i n vesti gat or.
P oi nt esti mates of C R R will be calc ulate d al o n g wit h t he 2 -si de d e xact 9 5 % CIs usi n g t he 
Wils o n met h o d.
C R R will be s u m marize d b y d ose le vels f or P hase 1 b a n d P hase 2 of t he st u d y  se paratel y.
D ur ati o n of Res p o nse
D o R is defi ne d, f or partici pa nts wit h a n o bjecti ve res p o nse per L u ga n o Res p o nse 
Classificati o n Criteria 2 0 1 4, as t he ti me fr o m t he first d oc u me ntati o n of o bjecti ve res p o nse 
u ntil P D, or deat h d ue t o a n y  ca use, w hic he ver occ urs first. 
D o R will be ce ns ore d o n t he date of t he last a de q uate disease assess me nt f or partici pa nts w h o 
d o n ot ha ve a n e ve nt ( P D or deat h d ue t o a n y ca use), o n t he date of t he last a de q uate disease 
assess me nt bef ore t he ne w a nti -ca ncer t hera p y f or partici pa nts w h o start a ne w a nti-ca ncer 
t hera py pri or t o a n e ve nt, or o n t he date of t he last a de q uate disease assess me nt bef ore t he 2 
or m ore missi n g disease assess me nts f or partici pa nts wit h a n e ve nt after 2 or m ore missi n g 
disease assess me nts.
D o R will be s u m marize d usi n g Ka pla n Meier met h o d a n d dis pla y e d gra p hicall y. Me dia n 
D o R a n d 2 -si de d 9 5 % CI ( base d o n t he Br o o k me yer -Cr o wle y  met h o d) will be pr o vi de d.
D o R will be s u m marize d b y d ose le vels f or P hase 1 b a n d P hase 2 of t he st u d y  se paratel y.
D ur ati o n of C o m plete Res p o nse
D o C R is defi ne d, f or partici pa nts wit h a C R per L u ga n o Res p o nse Classificati o n Criter ia 
2 0 1 4, as t he ti me fr o m t he first d oc u me ntati o n of a C R u ntil P D, or deat h d ue t o a n y ca use, 
w hic he ver occ urs first. 
D o C R will be ce ns ore d o n t he date of t he last a de q uate disease assess me nt f or partici pa nts 
w h o d o n ot ha ve a n e ve nt ( P D or deat h d ue t o a n y ca use), o n t he date of t he last a de q uate 
disease assess me nt bef ore t he ne w a nti -ca ncer t hera p y f or partici pa nts w h o start a ne w 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 1
a nti-ca ncer t hera p y pri or t o a n e ve nt, or o n t he date of t he last a de q uate disease assess me nt 
bef ore t he 2 or m ore missi n g d isease assess me nts f or partici pa nts wit h a n e ve nt after 2 or 
m ore missi n g disease assess me nts.
D o C R will be s u m marize d usi n g Ka pla n Meier met h o d a n d dis pla ye d gra p hicall y. Me dia n 
D o C R a n d 2 -si de d 9 5 % CI will be pr o vi de d.
D o C R will be s u m marize d b y  d ose le vels f or P hase 1 b a n d P hase 2 of t he st u d y  se paratel y.
Pr o gressi o n Free S ur vi v al
P F S is defi ne d as t he ti me fr o m t he date of first d ose u ntil P D per L u ga n o Res p o nse 
Classificati o n Criteria 2 0 1 4, or deat h d ue t o a n y ca use, w hic he ver occ urs first. 
P F S will be ce ns ore d as f oll o ws:

F or partici pa nts w h o d o n ot ha ve a n e ve nt ( P D per L u ga n o Res p o nse Classificati o n 
Criteria 2 0 1 4 or deat h d ue t o a n y ca use), ce ns ori n g will occ ur o n t he date of t he last 
a de q uate disease assess me nt;

F or partici pa nts w h o start a ne w a ntica ncer t hera p y pri or t o a n e ve nt, ce ns ori n g will 
occ ur o n t he date of t he last a de q uate disease assess me nt bef ore t he ne w a ntica ncer 
t hera py;

F or partici pa nts wit h a n e ve nt after a ga p of 2 or m ore missi n g disease assess me nts, 
ce ns ori n g will occ ur o n t he date of t he last a de q uate disease assess me nt bef ore t he 
ga p;

Partici pa nts w h o d o n ot ha ve a n a de q uate p ost -baseli ne disease assess me nt will be 
ce ns ore d o n t he date of first d ose of st u d y  i nter ve nti o n u nless deat h occ urs o n or 
bef ore t he ti me of t he sec o n d pla n ne d disease assess me nt (ie, ≤2 4 wee ks after t he date 
of first d ose) i n w hic h case t he deat h will be c o nsi dere d a n e ve nt.
P F S will be s u m marize d usi n g Ka pla n Meier met h o d a n d dis pla y e d gra p hicall y. Me dia n P F S 
a n d 2-si de d 9 5 % CI will be pr o vi de d.
P F S will be s u m marize d b y  d ose le vels f or P hase 1 b a n d P hase 2 of t he st u d y se paratel y.
9. 4. 3. 2. S afet y A n al yses
9. 4. 3. 2. 1. A d verse E ve nts
A Es will gra de d b y t he i n vesti gat or acc or di n g t o t he C T C A E v 5. 0 a n d c o de d usi n g 
Me d D R A. A E data will be re p orte d i n ta bles a n d listi n gs. S u m m aries of A E b y a p pr o priate 
Me d D R A ter ms, t o xicit y  gra de, a n d seri o us ness a n d relati o ns hi p t o st u d y treat me nt will be 
prese nte d b y d ose le vels, as well as s u m maries of A Es lea di n g t o deat h a n d pre mat ure 
wit h dra wal fr o m st u d y  treat me nt. T he n u m ber a n d perce nta ge of partici pa nts w h o 
e x perie nce d a n y A E, S A E, treat me nt relate d A E, a n d treat me nt relate d S A E will be 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 2
s u m marize d acc or di n g t o w orst t o xicit y gra des. T he s u m maries will prese nt A Es o n t he 
e ntire st u d y peri o d. 
9. 4. 3. 2. 2. L a b or at or y Test A b n or m alities
T he la b orat or y res ults will be gra de d acc or di n g t o t he N CI C T C A E v 5. 0 se verit y gra de a n d 
will be a nal yz e d usi n g s u m mar y statistics. T he w orst o n-treat me nt gra des d uri n g t he 
treat me nt peri o d will be s u m marize d. S hifts i n t o xicit y gra di n g fr o m baseli ne t o hi g hest 
gra de d uri n g t he o n -treat me nt peri o d will be dis pla ye d f or eac h la b orat or y test. T he a nalys es 
will s u m marize la b orat or y tests o n t he e ntire st u d y peri o d.
F or la b orat or y  tests wit h o ut N CI C T C A E gra de defi niti o ns, res ults will be cate g orize d as 
n or mal, a b n or mal, or n ot d o ne. O nl y  partici pa nts wit h p ost-baseli ne la b orat or y  val ues will be 
i ncl u de d i n t hese a nalys es. F urt her details of a nal yses f or all t he la b orat or y  para meters will 
be pr o vi de d i n t he S A P.
9. 4. 3. 3. P h ar m ac o ki netic A n al yses f or P F - 0 7 9 0 1 8 0 1
P K data a nal ys es will i ncl u de descri pti ve s u m mar y statistics of t he pre-d ose a n d E OI 
P F -0 7 9 0 1 8 0 1 c o nce ntrati o ns b y  st u d y visit, ti me p oi nts, a n d d ose le vels. I n a d diti o n, t he P K 
data fr o m t his st u d y  ma y be use d t o de vel o p a p o p ulati o n P K m o del a n d ma y als o be p o ole d 
wit h ot her st u dies f or p o p ulati o n P K m o del de vel o p me nt. T he c orrelati o ns bet wee n 
P F -0 7 9 0 1 8 0 1 e x p os ure para meters a n d p har mac o d y na mic bi o mar ker, efficac y  a n d/ or safety 
o utc o mes will be e x pl ore d if data all o ws. T he res ults of t hese m o deli n g a nal y ses will be 
re p orte d separatel y fr o m t he cli nical st u d y re p ort.
T he p ote ntial D DI bet wee n P F- 0 7 9 0 1 8 0 1, tafasita ma b, a n d/ or le nali d o mi de ma y  als o be 
e val uate d if data all o ws.
9. 4. 3. 4. I m m u n o ge nicit y A n al yses f or P F-0 7 9 0 1 8 0 1
F or i m m u n o ge nicit y data, t he perce nta ge of partici pa nts wit h p osi ti ve A D A will be 
s u m marize d. Listi n gs a n d s u m mar y ta b ulati o ns of t he A D A data at baseli ne a n d p ost-first 
d ose will be ge nerate d. Sa m ples ma y  als o be a nal yze d f or t he prese nce of N A b, a n d a n y data 
will be si milarl y  s u m marize d. F or partici pa nts wit h p ositi ve A D A or N A b, t he ma g nit u de 
(titer), ti me of o nset, a n d d urati o n of A D A or N A b res p o nse will als o be descri be d, if data 
per mit. T he p ote ntial i m pact of i m m u n o ge nicit y  o n P K a n d cli nical res p o nse i ncl u di n g 
p har mac o d y n a mic mar kers, safet y/ t olera bility a n d eff icac y ma y be e x pl ore d, if warra nte d b y 
t he data.
9. 4. 4. Terti ar y/ E x pl or at or y E n d p oi nt(s) A n al ysis
Res ults of e x pl orat or y  e n d p oi nt a nal yses ma y be descri be d i n t he C S R t o t he e xte nt p ossi ble. 
D ue t o t he e x pl orat or y  nat ure of t he e n d p oi nts, t he ass ociate d data a nalys es ma y n ot be 
c o m plete d at t he ti me of t he C S R pre parati o n. If res ults of e x pl orat or y  e n d p oi nt a nal yses 
ca n n ot be i ncl u de d i n t he C S R, t he y ma y be disse mi nate d t o t he scie ntific c o m m u nit y t o t he 
e xte nt p ossi ble t hr o u g h prese ntati o n at scie ntific meeti n gs a n d/ or p u blicati o n i n 
peer -re vie we d scie ntific j o ur nals.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 3
9. 4. 5. Ot her S afet y A n al yses
T he Safet y A nal ysis Set will be t he pri mar y  p o p ulati o n f or safet y e val uati o n.
A Es, E C Gs, a n d safet y  la b orat or y data will be re vie we d a n d s u m marize d b y t he sp o ns or o n 
a n o n g oi n g basis d uri n g t he st u d y  t o e val uate t he safety of partici pa nts. A n y cli nical 
la b orat or y, E C G, B P, a n d P R a b n or malities of p ote ntial cli nical c o ncer n will be descri be d. 
Safet y  data will be prese nte d i n ta b ular a n d/ or gra p hical f or mat a n d s u m marize d 
descri pt i vely, w here a p pr o priate.
Me dical hist or y  a n d p h ysical e xa mi nati o n c ollecte d d uri n g t he c o urse of t he st u d y will be 
c o nsi dere d s o urce data a n d will n ot be re q uire d t o be re p orte d, u nless ot her wise n ote d. 
H o we ver, a n y u nt o war d fi n di n gs i de ntifie d o n p h ysica l a n d/ or ne ur ol o gical e xa mi nati o ns 
c o n d ucte d d uri n g t he acti ve c ollecti o n peri o d will be ca pt ure d as A Es, if t h ose fi n di n gs meet 
t he defi niti o n of a n A E. Data c ollecte d at Scree ni n g t hat are use d f or i ncl usi o n/e xcl usi o n 
criteria, s uc h as E C Gs, a n d vital si g ns, will be c o nsi dere d s o urce data, a n d will n ot be 
re q uire d t o be re p orte d, u nless ot her wise n ote d. De m o gra p hic data c ollecte d at Scree ni n g will 
be re p orte d.
9. 4. 5. 1. Electr oc ar di o gr a m A n al yses
C ha n ges fr o m baseli ne f or t he E C G para meters Q T i nter val, heart rate, Q Tc F i nter val, P R 
i nter val, a n d Q R S c o m ple x will be s u m marize d b y d ose le vel a n d ti me.
T he n u m ber ( %) of partici pa nts wit h ma xi m u m p ost- d ose Q Tc F val ues a n d ma xi m u m 
i ncreases fr o m baseli ne i n t he f oll o wi n g cate g ories will be ta b ulate d b y treat me nt:
S afet y Q Tc F Assess me nt 
De gree of Pr ol o n g ati o n
Mil d ( ms)
M o der ate ( ms)
Se vere ( m s)
A bs ol ute val ue
> 4 5 0 -4 8 0
> 4 8 0 -5 0 0
> 5 0 0
I ncrease fr o m baseli ne
3 0 -6 0
> 6 0
9. 4. 6. Ot her A n al yses
P har mac o ge n o mic or bi o mar ker data fr o m Retai ne d Researc h Sa m ples ma y be c ollecte d 
d uri n g or after t he trial a n d retai ne d f or f ut ure a nal yses; t he res ults of s uc h a nal ys es are n ot 
pla n ne d t o be i ncl u de d i n t he C S R.
9. 5. I nteri m A n al yses
N o f or mal i nteri m a nal ys is will be c o n d ucte d f or t his st u d y. As t his is a n o pe n-la bel st u dy, 
t he s p o ns or may c o n d uct u n bli n de d re vie ws of t he data d uri n g t he c o urse of t he st u d y f or t he 
p ur p ose of safet y assess me nt, a n d/ or s u p p orti n g cli nical de vel o p me nt.
9. 6. S a m ple Size Deter mi n ati o n
P hase 2 of t he st u d y will n ot be i nitiate d per b usi ness decisi o n ma de b y Pfizer (pr ot oc ol 
a me n d me nt 2).
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 4
P h ase 1 b:
T he pri mar y  o bjecti ve i n t he P hase 1 b of t he st u d y is t o assess D LTs, safet y a n d t olera bilit y 
of P F - 0 7 9 0 1 8 0 1 i n c o m bi nati o n wit h tafasita ma b a n d le nali d o mi de i n or der t o select u p t o 
2 fi xe d d oses of P F-0 7 9 0 1 8 0 1 t o e x pl ore i n P hase 2. T he tar get n u m ber of partici pa nts per 
c o h ort is 2-4, a n d a mi ni m u m of 2 -4 D L T -e val ua ble partici pa nts is re q uire d at eac h teste d 
d ose le vel of P F -0 7 9 0 1 8 0 1. A p pr o xi matel y  6 t o 9 D LT- e val ua ble partici pa nts will be treate d 
at t he M T D or hi g hest saf e teste d d ose le vel f or P F -0 7 9 0 1 8 0 1 bef ore pr ocee di n g t o P hase 2. 
T he act ual n u m ber of partici pa nts t o be e nr olle d will de pe n d o n t he n u m ber of d ose le vels 
e val uate d a n d t he n u m ber of partici pa nts treate d at eac h d ose le vel. It is esti mate d t hat 
a p pr o xi mat el y 2 0 partici pa nts will be e nr olle d i n P hase 1 b.
If a ny partici pa nt is dee me d n o n -e val ua ble f or D L T, a d diti o nal partici pa nts ma y  be e nr olle d 
t o e ns ure t here are a s ufficie nt n u m ber of e val ua ble partici pa nts i n t he P hase 1 b.
P h ase 2:
U p t o 2 fi xe d d oses will be selecte d base d o n P hase 1 b data f or f urt her e val uati o n i n P hase 2 
of t he st u d y . A p pr o xi matel y 2 5 partici pa nts will be treate d f or eac h selecte d d ose. T he 
sa m ple size is n ot deter mi ne d base d o n statistical h yp ot hesis testi n g c o nsi derati o ns; rat her, it 
is base d o n cli nical c o nsi derati o ns t hat t he state d sa m ple size will pr o vi de s ufficie nt e vi de nce 
of preli mi nar y  a ntit u m or acti vit y of P F- 0 7 9 0 1 8 0 1 i n c o m bi nati o n wit h tafasita ma b a n d 
le nali d o mi de, a n d f or d ose selecti o n base d o n e x p os ure-res p o nse a nal ys es.
O R R ca n be esti mate d wit h a ma xi m u m sta n dar d err or of 1 0 % wit h 2 5 partici pa nts per ar m.
Ta ble 1 1 pr o vi des t he 9 5 % CIs f or O R R base d o n Wils o n met h o d f or differe nt o bser ve d 
res p o nses.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 5
T a ble 1 1.
S a m ple Size a n d 9 5 % CI f or O R R b ase d o n Wils o n Met h o d ( wit h 
C o nti n uit y C orrecti o n)
N = 2 5
N u m ber of res p o nses
O bser ve d O R R
9 5 % CI f or O R R
1
0. 0 4
0. 0 0 2, 0. 2 2 3
2
0. 0 8
0. 0 1 4, 0. 2 7 5
3
0. 1 2
0. 0 3 2, 0. 3 2 3
4
0. 1 6
0. 0 5 3, 0. 3 6 9
5
0. 2
0. 0 7 6, 0. 4 1 3
6
0. 2 4
0. 1 0 2, 0. 4 5 5
7
0. 2 8
0. 1 2 9, 0. 4 9 6
8
0. 3 2
0. 1 5 7, 0. 5 3 6
9
0. 3 6
0. 1 8 7, 0. 5 7 4
1 0
0. 4
0. 2 1 8, 0. 6 1 1
1 1
0. 4 4
0. 2 5 0, 0. 6 4 7
1 2
0. 4 8
0. 2 8 3, 0. 6 8 2
1 3
0. 5 2
0. 3 1 8, 0. 7 1 7
1 4
0. 5 6
0. 3 5 3, 0. 7 5 0
1 5
0. 6
0. 3 8 9, 0. 7 8 2
1 6
0. 6 4
0. 4 2 6, 0. 8 1 3
1 8
0. 7 2
0. 5 0 4, 0. 8 7 1
2 0
0. 8
0. 5 8 7, 0. 9 2 4
2 2
0. 8 8
0. 6 7 7, 0. 9 6 8
9. 7. St atistic al Met h o ds a n d Decisi o n Criteri a
T he m T PI - 2 desi g n ( wit h tar get p T = 0. 3, e 1 = 0. 0 5, e 2 = 0. 0 5) will be utilize d f or d ose fi n di n g 
of t he c o m bi nati o n t hera p y, wit h t he d ose le vel of tafasita ma b a n d le nali d o mi de fi xe d. T he 
m T PI -2 desi g n uses a Ba y esia n statistics fra me w or k a n d a beta bi n o mial hierarc hical m o del 
t o c o m p ute t he U P M of d osi n g i nter vals. T he d ose i nter val t hat has t he lar gest U P M is 
selecte d as t he wi n ni n g m o del. T he d ose de-escalati o n/escalati o n rec o m me n dati o n is as 
s h o w n bel o w:

If i nter vals {( 0. 1 5, 0. 2 5), ( 0. 0 5, 0. 1 5), ( 0, 0. 0 5) } e x hi bit t he lar gest U P M: escalate t o 
ne xt hi g her d ose;

If i nter val ( 0. 2 5, 0. 3 5) e x hi bits t he lar gest U P M: sta y at c urre nt d ose;

If i nter vals {( 0. 3 5, 0. 4 5), ( 0. 4 5, 0. 5 5), ( 0. 5 5, 0. 6 5), ( 0. 6 5, 0. 7 5), ( 0. 7 5, 0. 8 5), ( 0. 8 5, 
0. 9 5), ( 0. 9 5, 1) } e x hi bit t he lar gest U P M: de -escalate t o a l o wer d ose.
T he decisi o n r ules f or m T PI -2 desi g n (tar get p T = 0. 3, el = 0. 0 5 , e 2 = 0. 0 5) are liste d i n 
Ta ble 1 2 .
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol T e m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 6
T a ble 1 2 . m T PI -2 Decisi o n R ules ( p T = 0. 3, e 1 = 0. 0 5, e 2 = 0. 0 5)
N u m ber of P atie nts
N u m ber of P atie nts wit h D L Ts
1
2
3
4
5
6
7
8
9
1 0
1 1
1 2
1 3
1 4
1 5
0
E
E
E
E
E
E
E
E
E
E
E
E
E
E
E
1
D
D
S
S
E
E
E
E
E
E
E
E
E
E
E
2
D U
D
D
D
S
S
S
E
E
E
E
E
E
E
3
D U
D U
D
D
D
D
S
S
S
S
E
E
E
4
D U
D U
D U
D
D
D
D
D
S
S
S
S
5
D U
D U
D U
D U
D U
D
D
D
D
D
S
6
D U
D U
D U
D U
D U
D U
D
D
D
D
7
D U
D U
D U
D U
D U
D U
D U
D
D
8
D U
D U
D U
D U
D U
D U
D U
D U
9
D U
D U
D U
D U
D U
D U
D U
1 0
D U
D U
D U
D U
D U
D U
1 1
D U
D U
D U
D U
D U
1 2
D U
D U
D U
D U
1 3
D U
D U
D U
1 4
D U
D U
1 5
D U
E = Escalate t o t he ne xt hi g her d ose le vel 
S = Sta y at t he c urre nt d ose le vel 
D = De -escalate t o t he ne xt l o wer d ose le vel 
D U = T he c urre nt d ose le vel is u nacce pta bl y t o xic a n d s h o ul d be eli mi nate d fr o m f urt her d ose fi n di n g
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 7
1 0. S U P P O R TI N G D O C U M E N T A TI O N A N D O P E R A TI O N A L C O N SI D E R A TI O N S
1 0. 1. A p pe n di x 1: Re g ul at or y, Et hic al, a n d St u d y O versi g ht C o nsi der ati o ns
1 0. 1. 1. Re g ul at or y a n d Et hic al C o nsi der ati o ns
T his st u d y  will be c o n d ucte d i n acc or da nce wit h t he pr ot oc ol a n d wit h t he f oll o wi n g:

C o nse ns us et hical pri nci ples deri ve d fr o m i nter nati o nal g ui deli nes, i ncl u di n g t he 
Declarati o n of Helsi n ki a n d CI O M S I nter nati o nal Et hical G ui deli nes;

A p plica ble I C H G C P g ui deli nes;

A p plica ble la ws a n d re g ulati o ns, i ncl u di n g a p plica ble pri vac y la ws.
T he pr ot oc ol, pr ot oc ol a me n d me nts, I C D, S R S D(s), a n d ot her rele va nt d oc u me nts 
(e g, a d vertise me nts) m ust be re vie we d a n d a p pr o ve d b y  t he s p o ns or, s u b mitte d t o a n IR B/ E C 
b y  t he i n vesti gat or, a n d re vie we d a n d a p pr o ve d b y t he I RB/ E C bef ore t he st u d y  is i nitiate d.
A n y  a me n d me nts t o t he pr ot oc ol will re q uire I R B/ E C a p pr o val bef ore i m ple me ntati o n of 
c ha n ges ma de t o t he st u d y desi g n, e xce pt f or c ha n ges necessar y  t o eli mi nate a n i m me diate 
hazar d t o st u d y  partici pa nts.
Pr ot oc ols a n d a n y s u bsta ntial a me n d me nts t o t he pr ot oc ol will re q uire healt h a ut h orit y  
a p pr o val pri or t o i nitiati o n e xce pt f or c ha n ges necessar y t o eli mi nate a n i m me diate hazar d t o 
st u d y partici pa nts.
T he i n vesti gat or will be res p o nsi ble f or t he f oll o wi n g:

Pr o vi di n g wr itte n s u m maries of t he stat us of t he st u d y t o t he I R B/ E C a n n uall y or 
m ore fre q ue ntl y  i n acc or da nce wit h t he re q uire me nts, p olicies, a n d pr oce d ures 
esta blis he d b y t he I R B/ E C.

N otif y i n g t he I R B/ E C of S A Es or ot her si g nifica nt safety fi n di n gs as re q uire d b y 
IR B/ E C pr oce d ures.

Pr o vi di n g o versi g ht of t he c o n d uct of t he st u d y at t he site a n d a d here nce t o 
re q uire me nts of 2 1 C F R, I C H G C P g ui deli nes, t he I R B/ E C, E ur o pea n re g ulati o n 
5 3 6/ 2 0 1 4 f or cli nical st u dies, E ur o pea n M D R
2 0 1 7/ 7 4 5 f or cli nical de vice researc h, 
a n d all ot her a p plica ble l ocal re g ulati o ns.
1 0. 1. 1. 1. Re p orti n g of S afet y Iss ues a n d Seri o us Bre ac hes of t he Pr ot oc ol or I C H G C P
I n t he e ve nt of a ny pr o hi biti o n or restricti o n i m p ose d (ie, cli nical h ol d) b y a n a p plica ble 
re g ulat or y a ut h ority i n a n y area of t he w orl d , or if t he i n vesti gat or is a ware of a n y ne w 
i nf or mati o n t hat mi g ht i nfl ue nce t he e val uati o n of t he be nefits a n d ris ks of t he st u d y 
i nter ve nti o n, Pfizer s h o ul d be i nf or me d i m me diatel y. 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 8
I n a d diti o n, t he i n vesti gat or will i nf or m Pfizer i m me diatel y of a n y urge nt safet y meas ures 
ta ke n by t he i n vesti gat or t o pr otect t he st u d y partici pa nts a gai nst a n y i m me diate hazar d, a n d 
of a n y seri o us breac hes of t his pr ot oc ol or of t he I C H G C P t hat t he i n vesti gat or bec o mes 
a ware of.
1 0. 1. 2. Fi n a nci al Discl os ure
I n vesti gat ors a n d s u b-i n vesti gat ors will pr o vi de t he s p o ns or wit h s ufficie nt, acc urate 
fi na ncial i nf or mati o n as re q ueste d t o all o w t he s p o ns or t o s u b mit c o m plete a n d acc urate 
fi na ncial certificati o n or discl os ure state me nts t o t he a p pr o priate re g ulat or y a ut h orities. 
I n vesti gators are res p o nsi ble f or pr o vi di n g i nf or mati o n o n fi na ncial i nterests d uri n g t he 
c o urse of t he st u d y a n d f or 1 ye ar after c o m pleti o n of t he st u d y.
1 0. 1. 3. I nf or me d C o nse nt/ Asse nt Pr ocess
T he i n vesti gat or or t he i n vesti gat or’s re prese ntati ve will e x plai n t he nat ure of t he st u d y , 
i ncl u di n g t he ris ks a n d be nefits, t o t he partici pa nt or t heir le gally a ut h orize d re prese ntati ve 
a n d a ns wer all q uesti o ns re gar di n g t he st u d y. T he partici pa nt or t heir le gall y a ut h orize d 
re prese ntati ve s h o ul d be gi ve n s ufficie nt ti me a n d o p p ort u nit y t o as k q uesti o ns a n d t o deci de 
w het her or n ot t o partici pate i n t he trial.
Partici pa nts m ust be i nf or me d t hat t heir partici pati o n is v ol u ntar y . Partici pa nts or t heir 
le gall y a ut h orize d re prese ntati ve (if all o we d b y l ocal re g ulati o ns) will be re q uired t o si g n a 
state me nt of i nf or me d c o nse nt t hat meets t he re q uire me nts of 2 1 C F R 5 0, l ocal re g ulati o ns, 
I C H G C P g ui deli nes, pri vac y a n d data pr otecti o n re q uire me nts, w here a p plica ble, a n d t he 
I RB/ E C or st u d y  ce nter.
T he i n vesti gat or m ust e ns ure t hat eac h st u d y  partici pa nt or t heir le gall y a ut h orize d 
re prese ntati ve is f ull y i nf or me d a b o ut t he nat ure a n d o bjecti ves of t he st u d y, t he s hari n g of 
data relate d t o t he st u d y , a n d p ossi ble ris ks ass ociate d wit h partici pati o n, i ncl u di n g t he ris ks 
ass ociate d wit h t he pr ocessi n g of t he partici pa nt’s pers o nal data. 
T he partici pa nt or t heir le gall y a ut h orize d re prese ntati ve m ust be i nf or me d t hat t heir pers o nal 
st u d y-relate d data will be use d b y t he s p o ns or i n acc or da nce wit h l ocal data pr otecti o n la w. 
T he le vel of discl os ure m ust als o be e x plai ne d t o t he partici pa nt or t heir le gall y  a ut h orize d 
re prese ntati ve.
T he partici pa nt or t heir le gall y a ut h orize d re prese ntati ve m ust be i nf or me d t hat t heir me dical 
rec or ds ma y be e xa mi ne d b y Cli nical Q uality Ass ura nce a u dit ors or ot her a ut h orize d 
pers o n nel a p p oi nte d b y t he s p o ns or, b y a p pr o priate I R B/ E C me m bers, a n d b y  i ns pect ors 
fr o m re g ulat or y a ut h orities.
T he i n vesti gat or f urt her m ust e ns ure t hat eac h st u d y  partici pa nt or t heir le gall y a ut h orize d 
re prese ntati ve is f ull y i nf or me d a b o ut his or her ri g ht t o access a n d c orrect t heir pers o nal data 
a n d t o wit h dra w c o nse nt f or t he pr ocessi n g of his or her pers o nal data.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 9
T he me dical rec or d m ust i ncl u de a state me nt t hat writte n i nf or me d c o nse nt was o btai ne d 
bef ore t he partici pa nt was e nr olle d i n t he st u d y a n d t he date o n w hic h t he writte n c o nse nt was 
o btai ne d. T he a ut h orize d pers o n o btai ni n g t he i nf or me d c o nse nt m ust als o si g n t he I C D.
Partici pa nts or t heir le gall y  a ut h orize d re prese ntati ve m ust be rec o nse nte d t o t he m ost c urre nt 
I RB/ E C versi o n of t he I R B/ E C- a p pr o ve d I C D(s) d uri n g t heir partici pati o n i n t he st u d y  as 
re q uire d per l ocal re g ulati o ns.
A c o p y of t he I C D(s) m ust be pr o vi de d t o t he partici pa nt or t heir le gall y a ut h orize d 
re prese ntati ve (if all o we d b y l ocal re g ulati o ns).
A partici pa nt w h o is rescree ne d is n ot re q uire d t o si g n a n ot her I C D if t he rescree ni n g occ urs 
wit hi n 2 8 da y s fr o m t he pre vi o us I C D si g nat ure date.
1 0. 1. 4. D at a Pr otecti o n
All parties will c o m pl y  wit h all a p plica ble la ws, i ncl u di n g la ws re gar di n g t he i m ple me ntati o n 
of or ga nizati o nal a n d tec h nical meas ures t o e ns ure pr otecti o n of partici pa nt data.
Partici pa nts’ pers o nal data will be st ore d at t he st u d y  site i n e ncr ypte d electr o nic a n d/ or pa per 
f or m a n d will be pass w or d-pr otecte d or sec ure d i n a l oc ke d r o o m t o e ns ure t hat o nl y  
a ut h orize d st u d y staff ha ve access. T he st u d y site will i m ple me nt a p pr o priate tec h nical a n d 
or ga nizati o nal meas ures t o e ns ure t hat t he pers o nal data ca n be rec o vere d i n t he e ve nt of 
disaster. I n t he e ve nt of a p ote ntial pers o nal data breac h, t he st u d y site will be res p o nsi ble f or 
deter mi ni n g w het her a pers o nal data breac h has i n fact occ urre d a n d, if s o, pr o vi di n g breac h 
n otificati o ns as re q uire d b y  la w.
T o pr otect t he ri g hts a n d free d o ms of partici pa nts wit h re gar d t o t he pr ocessi n g of pers o nal 
data, partici pa nts will be assi g ne d a si n gle, partici pa nt -s pecific n u merical c o de. A n y 
partici pa nt rec or ds or data sets t hat are tra nsferre d t o t he s p o ns or will c o ntai n t he n u merical 
c o de; partici pa nt na mes will n ot be tra nsferre d. All ot her i de ntifia ble data t ra nsferre d t o t he 
s p o ns or will be i de ntifie d b y t his si n gle, partici pa nt-s pecific c o de. T he st u d y site will 
mai ntai n a c o nfi de ntial list of partici pa nts w h o partici pate d i n t he st u d y , li n ki n g eac h 
partici pa nt’s n u merical c o de t o t heir act ual i de ntit y  a n d me dical rec or d I D. I n case of data 
tra nsfer, t he s p o ns or will pr otect t he c o nfi de ntialit y of partici pa nts’ pers o nal data c o nsiste nt 
wit h t he cli nical st u d y a gree me nt a n d a p plica ble pri vac y  la ws.
I nf or mati o n tec h n ol o g y s yste ms use d t o c ollect, pr ocess, a n d st ore st u dy- relate d data are 
sec ure d by t ec h nical a n d or ga nizati o nal sec urit y m eas ures desi g ne d t o pr otect s uc h data 
a gai nst acci de ntal or u nla wf ul l oss, alterati o n, or u na ut h orize d discl os ure or access. 
T he s p o ns or mai ntai ns S O Ps o n h o w t o res p o n d i n t he e ve nt of u na ut h orize d access, use, or 
discl os ure of s p o ns or i nf or mati o n or s y ste ms.
1 0. 1. 5. C o m mittees Str uct ure
T his st u d y  will n ot use a n E-D M C.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 0
1 0. 1. 6. Disse mi n ati o n of Cli nic al St u d y D at a
Pfizer f ulfills its c o m mit me nt t o p u blicl y  discl ose cli nical st u d y res ults t hr o u g h p osti n g t he 
res ults of st u dies o n w w w.cli nicaltrials. g o v ( Cli nical Trials. g o v), t he E u dra C T/ C TIS, a n d/ or 
w w w. pfizer.c o m, a n d ot her p u blic re gistries a n d we bsites i n acc or da nce wit h a p plica ble l ocal 
la ws/re g ulati o ns. I n a d diti o n, Pfizer re p orts st u d y res ults o utsi de of t he re q uire me nts of l ocal 
la ws/re g ulati o ns p urs ua nt t o its S O Ps.
I n all cases, st u dy res ults are re p orte d b y Pfizer i n a n o bjecti ve, acc urate, bala nce d, a n d 
c o m plete ma n ner a n d are re p orte d re gar dless of t he o utc o me of t he st u d y or t he c o u ntr y i n 
w hic h t he st u d y  was c o n d ucte d.
w w w.cli nicaltrials. g o v
Pfizer p osts cli nical trial res ults o n w w w.cli nicaltrials. g o v f or Pfizer -s p o ns ore d i nter ve nti o nal 
st u dies (c o n d ucte d i n patie nts) t hat e val uate t he safet y a n d/ or efficac y of a pr o d uct, 
re gar dless of t he ge o gra p hical l ocati o n i n w hic h t he st u d y is c o n d ucte d. T hese res ults are 
s u b mitte d f or p osti n g i n acc or da nce wit h t he f or mat a n d ti meli nes set f ort h b y U S la w.
E u dra C T/ C TI S
Pfizer p osts cli nical trial res ults o n E u dra C T/ C TI S f or Pfizer -s p o ns ored i nter ve nti o nal st u dies 
i n acc or da nce wit h t he f or mat a n d ti meli nes set f ort h b y E U re q uire me nts. 
w w w. pfizer.c o m
Pfizer p osts C S R s y n o pses a n d plai n -la n g ua ge st u d y res ults s u m maries o n w w w. pfizer.c o m 
f or Pfizer-s p o ns ore d i nter ve nti o nal st u dies at t he sa me ti me t he c orres p o n di n g st u d y res ults 
are p oste d t o w w w.cli nicaltrials. g o v. C S R s y n o pses will ha ve pers o nall y  i de ntifia ble 
i nf or mati o n a n o ny m ize d.
D oc u me nts wit hi n mar keti n g a p plicati o ns 
Pfizer c o m plies wit h a p plica ble l ocal la ws/re g ulati o ns t o p u blis h c li nical d oc u me nts i ncl u de d 
i n mar keti n g a p plicati o ns. Cli nical d oc u me nts i ncl u de s u m mar y d oc u me nts a n d C S Rs 
i ncl u di n g t he pr ot oc ol a n d pr ot oc ol a me n d me nts, sa m ple C R Fs, a n d S A Ps. Cli nical 
d oc u me nts will ha ve pers o nall y  i de ntifia ble i nf or mati o n a n o n ymize d.
Data s hari n g
Pfizer pr o vi des researc hers sec ure access t o partici pa nt-le vel data or f ull C S Rs f or t he 
p ur p oses of “ b o na -fi de scie ntific researc h” t hat c o ntri b utes t o t he scie ntific u n dersta n di n g of 
t he disease, tar get, or c o m p o u n d class. Pfizer will ma ke data fr o m t hese trials a vaila ble 
1 8 m o nt hs after st u d y  c o m pleti o n. Partici pa nt-le vel data will be a n o ny m ize d i n acc or da nce 
wit h a p plica ble pri vac y  la ws a n d re g ulati o ns. C S Rs will ha ve pers o nally i de ntifia ble 
i nf or mati o n a n o ny m ize d.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 1
Data re q uests are c o nsi de re d fr o m q ualifie d researc hers wit h t he a p pr o priate c o m pete ncies t o 
perf or m t he pr o p ose d a nal yses. Researc h tea ms m ust i ncl u de a bi ostatisticia n. Data will n ot 
be pr o vi de d t o a p plica nts wit h si g nifica nt c o nflicts of i nterest, i ncl u di n g i n di vi d uals 
re q uestin g access f or c o m mercial/c o m petiti ve or le gal p ur p oses.
1 0. 1. 7. D at a Q u alit y Ass ur a nce
All partici pa nt data relati n g t o t he st u d y will be rec or de d o n pri nte d or electr o nic C R F u nless 
tra ns mitte d t o t he s p o ns or or desi g nee electr o nicall y (e g, la b orat or y data). T he i n vesti gat or is 
res p o nsi ble f or verif yi n g t hat data e ntries are acc urate a n d c orrect b y p h ysicall y or 
electr o nicall y si g ni n g t he C R F.
G ui da nce o n c o m pleti o n of C R Fs will be pr o vi de d i n t he C R F C o m pleti o n Re q uire me nts 
d oc u me nt.
T he i n vesti gat or m ust e ns ure t hat t he C R Fs are sec urely st ore d at t he st u d y site i n e ncr y pte d 
electr o nic a n d/ or pa per f or m a n d are pass w or d - pr otecte d or sec ure d i n a l oc ke d r o o m t o 
pre ve nt access b y u na ut h orize d t hir d parties.
Q T L s are pre defi ne d para meters t hat are m o nit ore d d uri n g the st u d y. I m p orta nt de viati o ns 
fr o m t he Q T Ls a n d a ny re me dial acti o ns ta ke n will be s u m marize d i n t he C S R.
T he i n vesti gat or m ust per mit st u d y -relate d m o nit ori n g, a u dits, I R B/ E C re vie w, a n d 
re g ulat or y a ge nc y i ns pecti o ns a n d pr o vi de direct access t o s o urce rec or ds a n d d oc u me nts. 
T his verificati o n ma y  als o occ ur after st u d y c o m pleti o n. It is i m p orta nt t hat t he 
i n vesti gat or(s) a n d t heir rele va nt pers o n nel are a vaila ble d uri n g t he m o nit ori n g visits a n d 
p ossi ble a u dits or i ns pecti o ns a n d t hat s ufficie nt ti me is d e v ote d t o t he pr ocess.
M o nit ori n g details descri bi n g strate g y , i ncl u di n g defi niti o n of st u d y-critical data ite ms a n d 
pr ocesses (e g, ris k -base d i nitiati ves i n o perati o ns a n d q ualit y , s uc h as ris k ma na ge me nt a n d 
miti gati o n strate gies a n d a nal yt ical ris k-base d m o nit ori n g), met h o ds, res p o nsi bilities, a n d 
re q uire me nts, i ncl u di n g ha n dli n g of n o nc o m plia nce iss ues a n d m o nit ori n g tec h ni q ues 
(ce ntral, virt ual, or o n-site m o nit ori n g), are pr o vi de d i n t he Data Ma na ge me nt Pla n a n d 
m o nit ori n g pla n mai ntai ne d a n d utilize d b y  t he s p o ns or or desi g nee.
T he s p o ns or or desi g nee is res p o nsi ble f or t he data ma na ge me nt of t his st u d y , i ncl u di n g 
q ualit y  c hec ki n g of t he data.
Rec or ds a n d d oc u me nts, i ncl u di n g si g ne d I C Ds, pertai ni n g t o t he c o n d uct of t his st u d y  m ust 
be retai ne d b y t he i n vesti gat or f or 1 5 ye ars after st u d y c o m pleti o n u nless l ocal re g ulati o ns or 
i nstit uti o nal p olicies re q uire a l o n ger rete nti o n peri o d. N o rec or ds ma y be destr o ye d d uri n g 
t he rete nti o n peri o d wit h o ut t he writte n a p pr o val of t he s p o ns or. N o rec or ds ma y be 
tra nsferre d t o a n ot her l ocati o n or part y wit h o ut writte n n otificati o n t o t he s p o ns or. T he 
i n vesti gat or m ust e ns ure t hat t he rec or ds c o nti n ue t o be st ore d sec urely f or as l o n g as t he y are 
mai ntai ne d.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 2
W he n partici pa nt data are t o be delete d, t he i n vesti gat or will e ns ure t hat all c o pies of s uc h 
data are pr o m ptl y  a n d irre v oca bly delete d fr o m all s yste ms.
T he i n vesti gat or(s) will n otif y t he s p o ns or or its a ge nts i m me diatel y  of a n y re g ulat or y 
i ns pecti o n n otificati o n i n relati o n t o t he st u d y. F urt her m ore, t he i n vesti gat or will c o o perate 
wit h t he s p o ns or or its a ge nts t o pre pare t he i n vesti gat or site f or t he i ns pecti o n a n d will all o w 
t he s p o ns or or its a ge nt, w he ne ver feasi ble, t o be prese nt d uri n g t he i ns pecti o n. T he 
i n vesti gat or site a n d i n vesti gat or will pr o m ptl y res ol ve a ny discre pa ncies t hat are i de ntifie d 
bet wee n t he st u d y data a n d t he partici pa nt’s me dical rec or ds. T he i n vesti gat or will pr o m ptl y  
pr o vi de c o pies of t he i ns pecti o n fi n di n gs t o t he s p o ns or or its a ge nt. Bef ore res p o nse 
s u b missi o n t o t he re g ulat or y aut h orities, t he i n vesti gat or will pr o vi de t he s p o ns or or its 
a ge nts wit h a n o p p ort u nit y t o re vie w a n d c o m me nt o n res p o nses t o a n y s uc h fi n di n gs.
1 0. 1. 8. S o urce D oc u me nts
S o urce d oc u me nts pr o vi de e vi de nce f or t he e xiste nce of t he partici pa nt a n d s u bsta ntiate t he 
i nte grity of t he data c ollecte d. S o urce d oc u me nts are file d at t he i n vesti gat or site.
Data re p orte d o n t he C R F or e ntere d i n t he e C R F t hat are fr o m s o urce d oc u me nts m ust be 
c o nsiste nt wit h t he s o urce d oc u me nts or t he discre pa ncies m ust be e x plai ne d. T he 
i n vesti gat or ma y nee d t o re q uest pre vi o us me dical rec or ds or tra nsfer rec or ds, de pe n di n g o n 
t he st u d y. Als o, c urre nt me dical rec or ds m ust be a vaila ble.
Defi niti o n of w hat c o nstit utes s o urce data a n d its ori gi n ca n be f o u n d i n t he S o urce 
D oc u me nt L ocat or, w hic h is mai ntai ne d b y t he s p o ns or.
Descri pti o n of t he use of t he c o m p uterize d s yste m is d oc u me nte d i n t he Data Ma na ge me nt 
Pla n, w hic h is mai ntai ne d b y  t he s p o ns or.
T he i n vesti gat or m ust mai ntai n acc urate d oc u me ntati o n (s o urce data) t hat s u p p orts t he 
i nf or matio n e ntere d i n t he C R F.
T he s p o ns or or desi g nee will perf or m m o nit ori n g t o c o nfir m t hat data e ntere d i nt o t he C R F 
b y  a ut h orize d site pers o n nel are acc urate, c o m plete, a n d verifia ble fr o m s o urce d oc u me nts; 
t hat t he safety a n d ri g hts of partici pa nts are bei n g pr otecte d; a n d t hat t he st u d y  is bei n g 
c o n d ucte d i n acc or da nce wit h t he c urre ntl y a p pr o ve d pr ot oc ol a n d a n y ot her st u d y  
a gree me nts, t he I C H G C P g ui deli nes, a n d all a p plica ble re g ulat or y  re q uire me nts.
1 0. 1. 9. Use of Me dic al Rec or ds
I n certai n sit uati o ns, s p o ns or re vie w of re dacte d c o pies of partici pa nt me dical rec or ds ma y  be 
perf or me d (e. g., p ote ntial re vie w of ra di o gra p hic i ma ges b y  a n i n de pe n de nt t hir d part y 
i ma gi n g la b orat or y), w here et hicall y a n d scie ntificall y j ustifie d a n d per mitte d b y l ocal 
re g ulati o ns, t o ens ure partici pa nt safet y. 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 3
D ue t o t he p ote ntial f or a partici pa nt t o be re -i de ntifie d fr o m t heir me dical rec or ds, t he 
f oll o wi n g acti o ns m ust be ta ke n w he n me dical rec or ds are se nt t o t he s p o ns or or s p o ns or 
desi g nee:

T he i n vesti gat or or site staff m ust re da ct pers o nal i nf or mati o n fr o m t he me dical 
rec or d. T he pers o nal i nf or mati o n i ncl u des, b ut is n ot li mite d t o, t he f oll o wi n g: 
partici pa nt na mes or i nitials, partici pa nt dates (e g, birt h date, date of h os pital 
a d missi o n/ disc har ge, date of deat h), partici pa nt i d e ntificati o n n u m bers (e g, S ocial 
Sec urit y  n u m ber, healt h i ns ura nce n u m ber, me dical rec or d n u m ber, 
h os pital/i nstit uti o n i de ntifier), partici pa nt l ocati o n i nf or mati o n (e g, street a d dress, 
cit y, c o u ntr y, p ostal c o de, IP a d dress), partici pa nt c o ntact i nf or mati o n (e g, 
tele p h o ne/fa x n u m ber, e mail a d dress).

Eac h me dical rec or d m ust be tra ns mitte d t o t he s p o ns or or s p o ns or desi g nee usi n g 
s yste ms wit h tec h nical a n d or ga nizati o nal sec urit y meas ures t o e ns ure t he pr otecti o n 
of pers o nal data (e g, Fl ore nce is t he prefer re d sys te m if a vaila ble). 

T here ma y  be u n pla n ne d sit uati o ns w here t he s p o ns or ma y re q uest me dical rec or ds 
(e g, s hari n g me dical rec or ds s o t hat t he s p o ns or ca n pr o vi de st u d y-relate d a d vice t o 
t he i n vesti gat or). T he me dical rec or ds s h o ul d be s u b mitte d acc ordi n g t o t he pr oce d ure 
descri be d a b o ve.
1 0. 1. 1 0. St u d y a n d Site St art a n d Cl os ure
T he st u d y  start date is t he date of t he first partici pa nt’s first visit.
T he s p o ns or desi g nee reser ves t he ri g ht t o cl ose t he st u d y  site or ter mi nate t he st u d y at a n y 
ti me f or a ny reas o n at t he s ole discreti o n of t he s p o ns or, i ncl u di n g ( b ut n ot li mite d t o) 
re g ulat or y a ut h ority decisi o n, c ha n ge i n o pi ni o n of t he I R B/ E C, or c ha n ge i n be nefit -ris k 
assess me nt. St u d y sites will be cl ose d u p o n st u d y c o m pleti o n. A st u d y site is c o nsi dere d 
cl ose d w he n all re q uire d d oc u me nts a n d st u d y  s u p plies ha ve bee n c ollecte d a n d a st u d y-site 
cl os ure visit has bee n perf or me d.
T he i n vesti gat or ma y  i nitiate st u d y-site cl os ure at a n y ti me u p o n n otificati o n t o t he s p o ns or 
or desi g nee/ C R O if re q ueste d t o d o s o b y  t he res p o nsi ble IR B/ E C or if s uc h ter mi nati o n is 
re q uire d t o pr otect t he healt h of st u d y partici pa nts.
Reas o ns f or t he earl y cl os ure of a st u d y site b y t he s p o ns or ma y i ncl u de b ut are n ot li mite d 
t o:

Fail ure of t he i n vesti gat or t o c o m pl y  wit h t he pr ot oc ol, t he re q uire me nts of t he 
I RB/ E C or l ocal healt h a ut h orities, t he s p o ns or’s pr oce d ures, or t he I CH G C P 
g ui deli nes;

I na de q uate recr uit me nt of partici pa nts b y  t he i n vesti gat or;

Disc o nti n uati o n of f urt her st u d y  i nter ve nti o n de vel o p me nt.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 4
If t he st u dy is pre mat u rel y ter mi nate d or s us pe n de d, t he s p o ns or s hall pr o m ptl y i nf or m t he 
i n vesti gat ors, t he E Cs/I R Bs, t he re g ulat or y a ut h orities, a n d a n y C R O(s) use d i n t he st u d y of 
t he reas o n f or ter mi nati o n or s us pe nsi o n, as s pecifie d b y t he a p plica ble re g ulat or y 
re q uire me nts. T he i n vesti gat or s hall pr o m ptl y i nf or m t he partici pa nt a n d s h o ul d ass ure 
a p pr o priate partici pa nt t hera p y a n d/ or f oll o w - u p.
If t he s p o ns or deci des t o ter mi nate t he st u d y f or a reas o n u nrelate d t o t he safet y of st u d y 
i nter ve nti o n(s), partici pa nts ma y c o nti n ue t o recei ve st u d y i nter ve nti o n(s) per t he 
i n vesti gat or’s j u d g me nt a n d pr ot oc ol-s pecifie d safet y assess me nts will c o nti n ue t o be 
perf or me d f or t hese partici pa nts u ntil t he e n d of t he st u d y  as defi ne d i n Secti o n 4. 4 . A n y 
n o n -safety- relate d st u dy pr oce d ures a n d assess me nts ma y  be st o p pe d u p o n writte n 
n otificati o n fr o m t he s p o ns or.
St u d y  ter mi nati o n is als o pr o vi de d f or i n t he cli nical st u d y a gree me nt. If t here is a n y c o nflict 
bet wee n t he c o ntract a n d t his pr ot oc ol, t he c o ntract will c o ntr ol as t o ter mi nati o n ri g hts.
1 0. 1. 1 1. P u blic ati o n P olic y
F or m ultice nter trials, t he pri mar y  p u blicati o n will be a j oi nt p u blicati o n de vel o pe d by t he 
i n vesti gat or a n d Pfizer re p orti n g t he pri mar y e n d p oi nt(s) of t he st u d y c o veri n g all st u d y sites.
T he i n vesti gat or a grees t o refer t o t he pri mar y  p u blicati o n i n a n y s u bse q ue nt p u blicati o ns. 
Pfizer will n ot pr o vi de a n y fi na ncial c o m pe nsati o n f or t he i n vesti gat or’s partici pati o n i n t he 
pre parati o n of t he pri mar y c o n gress a bstract, p oster, prese ntati o n, or pri mar y  ma n uscri pt f or 
t he st u d y. 
I n vesti gat ors are free t o p u blis h i n di vi d ual ce nter res ults t hat t he y dee m t o be cli nicall y 
mea ni n gf ul after p u blicati o n of t he o verall res ults of t he st u d y  or 1 2 m o nt hs after pri mar y 
c o m pleti o n date or st u d y c o m pleti on at all sites, w hic he ver occ urs first, s u bject t o t he ot her 
re q uire me nts descri be d i n t his secti o n.
T he i n vesti gat or will pr o vi de Pfizer a n o p p ort u nit y  t o re vie w a n y pr o p ose d p u blicati o n or 
a n y ot her ty pe of discl os ure of t he st u d y res ults (c ollecti vel y, “ p u blicati o n”) bef ore it is 
s u b mitte d or ot her wise discl ose d a n d will s u b mit all p u blicati o ns t o Pfizer 3 0 da y s bef ore 
s u b missi o n. If a ny pate nt acti o n is re q uire d t o pr otect i ntellect ual pr o pert y ri g hts, t he 
i n vesti gat or a grees t o dela y t he discl os ure f or a peri o d n ot t o e xcee d a n a d diti o nal 6 0 da y s 
u p o n re q uest fr o m Pfizer. T his all o ws Pfizer t o pr otect pr o prietar y  i nf or mati o n a n d t o pr o vi de 
c o m me nts, a n d t he i n vesti gat or will, o n re q uest, re m o ve a n y pre vi o usl y u n discl ose d 
c o nfi de ntial i nf or mati o n bef ore discl os ure, e xce pt f or a n y  st u d y-i nter ve nti o n or Pfizer-relate d 
i nf or mati o n necessar y f or t he a p pr o priate scie ntific prese ntati o n or u n dersta n di n g of t he 
st u d y res ults. F or j oi nt p u blicati o ns, s h o ul d t here be disa gree me nt re gar di n g i nter pretati o n 
a n d/ or pr ese ntati o n of s pecific a nal ys is res ults, res ol uti o n of, a n d res p o nsi bilit y f or, s uc h 
disa gree me nts will be t he c ollecti ve res p o nsi bilit y  of all a ut h ors of t he p u blicati o n.
F or all p u blicati o ns relati n g t o t he st u d y, t he i n vesti gat or a n d Pfizer will c o m pl y wit h 
rec o g nize d et hical sta n dar ds c o ncer ni n g p u blicati o ns a n d a ut h ors hi p, i ncl u di n g t h ose 
esta blis he d b y t he I nter nati o nal C o m mittee of Me dical J o ur nal E dit ors. T he i n vesti gat or will 
discl ose a n y relati o ns hi p wit h Pfizer a n d a n y rele va nt p ote ntial c o nflict s of i nterest, i ncl u di n g 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 5
a n y fi na ncial or pers o nal relati o ns hi p wit h Pfizer, i n a n y p u blicati o ns. W he n a p plia ble, 
e dit orial or tec h nical s u p p ort pr o vi de d b y a t hir d part y a n d pai d f or b y Pfizer, or pr o vi de d b y 
a Pfizer e m pl o yee, ma y be a re p orta ble tra nsfer of val ue u n der t he S u ns hi ne Act f or U S
lice nse d p hys icia ns or ot her healt hcare pr ofessi o nals. All a ut h ors will ha ve access t o t he 
rele va nt statistical ta bles, fi g ures, a n d re p orts (i n t heir ori gi nal f or mat) re q uire d t o de vel o p 
t he p u blicati o n. T he res ults of t his st u d y ma y be p u blis he d or prese nte d at scie ntific meeti n gs 
b y  t he i n vesti gat or after p u blicati o n of t he o verall st u d y res ults or 1 ye ar after t he e n d of t he 
st u d y ( or st u dy ter mi nati o n), w hic he ver c o mes first. 
1 0. 1. 1 2. S p o ns or’s Me dic all y Q u alifie d I n di v i d u al
T he s p o ns or will desi g nate a me dicall y q ualifie d i n di vi d ual ( M QI, als o k n o w n as t he me dical 
m o nit or) t o a d vise t he i n vesti gat or o n st u d y- relate d me dical q uesti o ns. T he c o ntact 
i nf or mati o n f or t he st u d y me dical m o nit or is d oc u me nte d i n t he St u d y  Tea m C o ntact L ist 
l ocate d i n t he I n vesti gat or Site File.
Partici pa nts are pr o vi de d wit h a Pfizer st u d y i nf or mati o n car d at t he ti me of i nf or me d 
c o nse nt, w hic h i ncl u des c o ntact i nf or mati o n f or t heir i n vesti gat or i n case of st u d y -relate d 
me dical q uesti o ns . T he stu d y  i nf or mati o n car d c o ntai ns, at a mi ni m u m, (a) st u d y n u m ber, ( b) 
partici pa nt’s st u d y i de ntificati o n n u m ber, a n d (c) pri nci pal i n vesti gat or c o ntact i nf or mati o n.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 6
1 0. 2. A p pe n di x 2: Cli nic al L a b or at or y Assess me nts
T he f oll o wi n g safet y la b orat or y  tests will be perf or me d at ti mes defi ne d i n t he S o A secti o n of 
t his pr ot oc ol. A d diti o nal la b orat or y res ults ma y be re p orte d o n t hese sa m ples as a res ult of 
t he met h o d of a nalys is or t he t ype of a nal yz er use d b y t he cli nical la b orat or y, or as deri ve d 
fr o m calc ulate d val ues. T hese a d diti o nal tests w o ul d n ot re q uire a d diti o nal c ollecti o n of 
bl o o d. U nsc he d ule d cli nical la b orat or y  meas ure me nts ma y be o btai ne d at a n y ti me d uri n g t he 
st u d y t o assess a ny percei ve d safet y iss ues.
T a ble 1 3 . St u d y -S pecific Cli nic al L a b or at or y Assess me nts
Test
N otes
H e m at ol o g y
H e m o gl o bi n
Platelets
W B C
A bs ol ute Ne utr o p hils
Res ults will be re p orte d as a bs ol ute val ues after 
c o n versi o n a n d gra de d acc or di n g t o C T C A E v 5. 0 
criteria. 
A bs ol ute L y m p h oc ytes
A bs ol ute M o n oc ytes
A bs ol ute E osi n o p hils
A bs ol ute Bas o p hils

Retic ul oc ytes 

At C 1 (t o be e ntere d i n t he C R F f or a ne mia ≥ Gra de 
2 at baseli ne).

As cli nicall y i n dicate d ( w he n ≥ Gra de 2 a ne mia).
C he mistr y
A L T
A S T
A L P
S o di u m
P otassi u m
Ma g nesi u m
C hl ori de
T otal Calci u m
T otal Bilir u bi n * * *
* * * F or H y’s la w p ote ntial cases, i n a d diti o n t o re peati n g 
A S T a n d A L T, la b orat or y tests i ncl u de al b u mi n, 
creati ne ki nase, t otal bilir u bi n, direct a n d i n direct 
bilir u bi n, ga m ma -gl uta m yl tra nsferase, P T/I N R, a n d 
al kali ne p h os p hatase
Urea   
Creati ni ne
Uric Aci d   
Gl uc ose ( n o n -faste d)
Al b u mi n
P h os p h or us or P h os p hate
L D H
Scree ni n g, C 1 visits a n d as cli nicall y i n dicate d. 
C o a g ul ati o n
P T or I N R
P T T or a P T T
Uri n al ysis ( di pstic k is acce pt a ble)
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 7
T a ble 1 3 . St u d y -S pecific Cli nic al L a b or at or y Assess me nts
Test
N otes
Uri ne di pstic k f or uri ne pr otei n, bl o o d, 
le u k oc ytes. If p ositi ve, c ollect a micr osc o pic 
(refle x testi n g).
I m m u n o gl o b uli n
I g G, I g M, I g A
He p atitis p a nel f or scree ni n g 
H B V tests ( H Bs A g, H Bc A b, H Bs A b), a n d H C V 
A b 
T o be perf or me d at Scree ni n g a n d as cli nicall y i n dicate d 
per PI assess me nt t hr o u g h o ut st u d y peri o d. I n t he case 
of a p pare nt o n g oi n g H B V or H C V i nfecti o n, refle x 
ser u m D N A or R N A viral l oa d testi n g, res pecti vel y, will 
be perf or me d if re q uire d b y l ocal re g ul ati o n. Partici pa nts 
pre vi o usl y i nfecte d wit h H B V b ut wit h o ut acti ve 
i nfecti o n s h o ul d be m o nit ore d f or si g ns a n d s y m pt o ms 
of H B V reacti vati o n w hile recei vi n g le nali d o mi de. F or 
partici pa nts wit h acti ve H B V at a n y ti me d uri n g t he 
st u d y, a d mi nistrati o n of st u dy i nter ve nti o ns s h o ul d be 
i nterr u pte d a n d starti n g H B V treat me nt s h o ul d be 
c o nsi dere d i n parallel wit h c o ns ultati o n wit h a 
he pat ol o gist. See als o R E V LI MI D S m P C a n d 
Secti o n 1 0. 1 0. 2 re q uire me nts i n Ja pa n.
HI V at scree ni n g 
C D 4 c o u nt a n d HI V viral l oa d

F or partici pa nts wit h hist or y of HI V 

C D 4 a n d HI V viral l oa d res ults are t o be 
d oc u me nte d i n s o urce d oc u me nts (are n ot
re q uire d i n t he C R F).
Pre g n a nc y Test
F or fe male partici pa nts of c hil d beari n g p ote ntial, 
o n ser u m or uri ne 
Test se nsiti vit y m ust be at least 2 5 mI U/ m L.
F S H
Scree ni n g o nl y; f or c o nfir mati o n of p ost me n o pa usal 
stat us.
T he i n vesti gat or m ust re vie w t he la b orat or y re p ort, d oc u me nt t his re vie w, a n d rec or d a n y 
cli nicall y rele va nt c ha n ges occ urri n g d uri n g t he st u d y i n t he A E secti o n of t he C R F.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 8
1 0. 3. A p pe n di x 3: A d verse E ve nts: Defi niti o ns a n d Pr oce d ures f or Rec or di n g, 
E v al u ati n g, F oll o w -U p, a n d Re p ort i n g
1 0. 3. 1. Defi niti o n of A E
A E Defi niti o n

A n A E is a n y u nt o war d me dical occ urre nce i n a patie nt or cli nical st u d y 
partici pa nt, te m p orall y ass ociate d wit h t he use of st u d y i nter ve nti o n, w het her or 
n ot c o nsi dere d relate d t o t he st u d y  i nter ve nti o n.

N ote: A n A E ca n t heref ore be a ny u nfa v ora ble a n d u ni nte n de d si g n (i ncl u di n g a n 
a b n or mal la b orat or y fi n di n g), sy m pt o m, or disease ( ne w or e xacer bate d) 
te m p orall y ass ociate d wit h t he use of st u d y i nter ve nti o n.
E ve nts Meeti n g
t he A E Defi niti o n

A n y  a b n or mal la b orat or y test res ults ( he mat ol o g y, cli nical c he mistr y, or 
uri nal y sis) or ot her safet y assess me nts (e g, E C G, ra di ol o gical sca ns, vital si g n 
meas ure me nts), i ncl u di n g t h ose t hat w orse n fr o m baseli ne, c o nsi dere d cli nicall y  
si g nifica nt i n t he me dical a n d scie ntific j u d g me nt of t he i n vesti gat or. A n y 
a b n or mal la b orat or y test res ults t hat meet a n y of t he c o n diti o ns bel o w m ust be 
rec or de d as a n A E:
o
Is ass ociate d wit h acc o m pa n yi n g sy m pt o ms;
o
Re q uires a d diti o nal dia g n ostic testi n g or me dical/s ur gical i nter ve nti o n;
o
Lea ds t o a c ha n ge i n st u d y d osi n g ( o utsi de of a n y pr ot oc ol-s pecifie d d ose 
a dj ust me nts) or disc o nti n uati o n fr o m t he st u d y , si g nifica nt a d diti o nal 
c o nc o mita nt dr u g treat me nt, or ot her t hera p y.

E xacer bati o n of a c hr o nic or i nter mitte nt pree xisti n g c o n diti o n, i ncl u di n g a n 
i ncrease i n eit her fre q ue nc y a n d/ or i nte nsit y of t he c o n diti o n.

Ne w c o n diti o n detecte d or dia g n ose d after st u d y i nter ve nti o n a d mi nistrati o n, e ve n 
t h o u g h it ma y ha ve bee n prese nt bef ore t he start of t he st u d y.

Si g ns, s y m pt o ms, or t he cli nical se q uelae of a s us p ecte d dr u g-dr u g i nteracti o n.

Si g ns, s y m pt o ms, or t he cli nical se q uelae of a s us pecte d o ver d ose of eit her st u d y  
i nter ve nti o n or a c o nc o mita nt me dicati o n. O ver d ose per se will n ot be re p orte d as 
a n A E or S A E u nless it is a n i nte nti o nal o ver d ose ta ke n wit h p o ssi ble 
s uici dal/self- har mi n g i nte nt. S uc h o ver d oses s h o ul d be re p orte d re gar dless of 
se q uelae.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 9
E ve nts N O T Meeti n g t he A E Defi niti o n

A n y  cli nicall y si g nifica nt a b n or mal la b orat or y fi n di n gs or ot her a b n or mal safety 
assess me nts t hat are ass ociate d wit h t he u n derl yi n g disease, u nless j u d ge d b y  t he 
i n vesti gat or t o be m ore se vere t ha n e x pecte d f or t he partici pa nt’s c o n diti o n.

T he disease/ dis or der bei n g st u die d or e x pecte d pr o gressi o n, si g ns, or s y m pt o ms of 
t he disease/ dis or der bei n g st u die d, u nless m ore se vere t ha n e x pecte d f or t he 
partici pa nt’s c o n diti o n.

W orse ni n g of si g ns a n d s y m pt o ms of t he mali g na nc y  u n der st u d y s h o ul d be 
rec or de d as A Es i n t he a p pr o priate secti o n of t he C R F. Disease pr o gressi o n 
assesse d b y meas ure me nt of mali g na nt lesi o ns o n ra di o gra p hs o r ot her met h o ds 
s h o ul d n ot be re p orte d as A Es

Me dical or s ur gical pr oce d ure (e g, e n d osc o p y, a p pe n dect o m y): t he c o n diti o n t hat 
lea ds t o t he pr oce d ure is t he A E.

Sit uati o ns i n w hic h a n u nt o war d me dical occ urre nce di d n ot occ ur (s ocial a n d/ or 
c o n ve nie nce a d mi ssi o n t o a h os pital).

A ntici pate d da y -t o-d a y  fl uct uati o ns of pree xisti n g disease(s) or c o n diti o n(s) 
prese nt or detecte d at t he start of t he st u d y  t hat d o n ot w orse n.
1 0. 3. 2. Defi niti o n of a n S A E
A n S A E is defi ne d as a n y u nt o w ar d me dic al occ urre nce t h at, at a n y d ose, meets 1 or 
m o re of t he criteri a liste d bel o w:
a.
Res ults i n de at h
b.
Is life-t hre ate ni n g
T he ter m “life -t hreate ni n g” i n t he defi niti o n of “seri o us” refers t o a n e ve nt i n w hic h 
t he partici pa nt was at ris k of deat h at t he ti me of t he e ve nt. It d oes n ot refer t o a n 
e ve nt t hat h y p ot heticall y mi g ht ha ve ca use d deat h if it were m ore se vere.
c.
Re q uires i n p atie nt h os pit aliz ati o n or pr ol o n g ati o n of e xisti n g h os pit aliz ati o n
I n ge neral, h os pitalizati o n si g nifies t hat t he partici pa nt has bee n detai ne d ( us uall y 
i n v ol vi n g at least a n o ver ni g ht sta y) at t he h os pital or e mer ge nc y war d f or o bser vati o n 
a n d/ or treat me nt t hat w o ul d n ot ha ve bee n a p pr o priate i n t he p h ys icia n’s office or 
o ut patie nt setti n g. C o m plicati o ns t hat occ ur d uri n g h os pitalizati o n are A Es. If a 
c o m plicati o n pr ol o n gs h os pitalizati o n or f ulfills a n y ot her seri o us criteria, t he e ve nt is 
seri o us. W he n i n d o u bt as t o w het her “ h os pitalizati o n” occ urre d or was necessar y, t he 
A E s h o ul d be c o nsi dere d seri o us.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 0
H os pitalizati o n f or electi ve treat me nt of a pree xisti n g c o n diti o n t hat di d n ot w orse n 
fr o m baseli ne is n ot c o nsi dere d a n A E.
d.
Res ults i n persiste nt or si g nific a nt dis a bilit y/i nc a p acit y

T he ter m disa bilit y mea ns a s u bsta ntial disr u pti o n of a pers o n’s a bilit y  t o c o n d uct 
n or mal life f u ncti o ns.

T his defi niti o n is n ot i nte n de d t o i ncl u de e x perie nces of relati vely mi n or me dical 
si g nifica nce, s uc h as u nc o m plicate d hea dac he, na usea, v o miti n g, diarr hea, 
i nfl ue nza, a n d acci de ntal tra u ma (e g, s prai ne d a n kle), t hat ma y i nterfere wit h or 
pre ve nt e ver y d a y  life f u ncti o ns but d o n ot c o nstit ute a s u bsta ntial disr u pti o n.
e.
Is a c o n ge nit al a n o m al y/ birt h defect.
f.
Is a s us pecte d tr a ns missi o n vi a a Pfizer pr o d uct of a n i nfecti o us a ge nt, 
p at h o ge nic or n o n -p at h o ge nic. 
T he e ve nt ma y  be s us pecte d fr o m cli nical sy m pt o ms or la b orat or y  fi n di n gs i n dicati n g 
a n i nfecti o n i n a partici pa nt e x p ose d t o a Pfizer pr o d uct. T he ter ms “s us pecte d 
tra ns missi o n” a n d “tra ns missi o n” are c o nsi dere d s yn o n y m o us. T hese cases are 
c o nsi dere d u ne x pecte d a n d ha n dle d as seri o us e x pe dite d cases b y p har mac o vi gila nce
pers o n nel. S uc h cases are als o c o nsi dere d f or re p orti n g as pr o d uct defects, if 
a p pr o priate.
g.
Ot her sit u ati o ns:

Me dical or scie ntific j u d g me nt s h o ul d be e xercise d b y  t he i n vesti gat or i n deci di n g 
w het her S A E re p orti n g is a p pr o priate i n ot her sit uati o ns, s uc h as si g nifica nt 
me dical e ve nts t hat b ut ma y  je o par dize t he partici pa nt or ma y re q uire me dical or 
s ur gical i nter ve nti o n t o pre ve nt o ne of t he ot her o utc o mes liste d i n t he a b o ve 
defi niti o n. T hese e ve nts s h o ul d us uall y  be c o nsi dere d seri o us.

E xa m ples of s uc h e ve nts i ncl u de i n vasi ve or mali g na nt ca ncers, i nte nsi ve 
treat me nt i n a n e mer ge nc y r o o m or at h o me f or aller gic br o nc h os pas m, bl o o d 
d y scrasias or c o n v ulsi o ns t hat d o n ot res ult i n h os pitalizati o n, or de vel o p me nt of 
dr u g de pe n de nc y  or dr u g a b use.

Pr o gressi o n of t he mali g na nc y  u n der st u dy (i ncl u di n g si g ns a n d sy m pt o ms of 
pr o gressi o n) s h o ul d n ot be re p orte d as a n S A E u nless t he o utc o me is fatal wit hi n 
t he acti ve c ollecti o n peri o d. H os pitalizati o n d ue t o si g ns a n d sy m pt o ms of disease 
pr o gressi o n s h o ul d n ot be r e p orte d as a n S A E. If t he mali g na nc y has a fatal 
o utc o me d uri n g t he st u d y, t he e ve nt lea di n g t o deat h m ust be rec or de d as a n A E 
o n t he C R F, a n d as a n S A E wit h C T C A E Gra de 5 (see t he Assess me nt of Se verit y
secti o n) if it occ urs d uri n g t he acti ve c ollecti o n peri o d.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 1
1 0. 3. 3. Rec or di n g/ Re p orti n g a n d F oll o w -U p of A Es a n d/ or S A Es D uri n g t he Acti ve 
C ollecti o n Peri o d
A E a n d S A E Rec or di n g/ Re p orti n g
T he ta ble bel o w s u m marizes t he re q uire me nts f or rec or di n g A Es o n t he C R F a n d f or 
re p orti n g S A Es o n t he C T S A E Re p ort F or m t o Pfizer Safety t hr o u g h o ut t he acti ve 
c ollecti o n peri o d. T hese re q uire me nts are deli neate d f or 3 t y pes of e ve nts: ( 1) S A Es; ( 2) 
n o nse ri o us A Es; a n d ( 3) e x p os ure t o t he st u d y i nter ve nti o n u n der st u dy d uri n g 
pre g na nc y  or breastfee di n g, a n d occ u pati o nal e x p os ure. 
It s h o ul d be n ote d t hat t he C T S A E Re p ort F or m f or re p orti n g of S A E i nf or mati o n is n ot 
t he sa me as t he A E pa ge of t he C R F. W he n t he sa me data are c ollecte d, t he f or ms m ust 
be c o m plete d i n a c o nsiste nt ma n ner. A Es s h o ul d be rec or de d usi n g c o ncise me dical 
ter mi n ol o g y a n d t he sa me A E ter m s h o ul d be use d o n b ot h t he C R F a n d t he C T S A E 
Re p ort F or m f or re p orti n g of S A E i nf or mati o n.
S afe t y E ve nt
Rec or de d o n t he C R F
Re p orte d o n t he C T S A E 
Re p ort F or m t o Pfizer 
S afet y Wit hi n 2 4 H o urs 
of A w are ness
S A E
All
All
N o nseri o us A E
All
N o ne
E x p os ure t o t he st u d y  
i nter ve nti o n u n der st u dy 
d uri n g pre g na nc y  or 
breastfee di n g 
All A Es/ S A Es ass ociate d 
wit h E D P or E D B
N ote: I nsta nces of E D P or 
E D B n ot ass ociate d wit h a n 
A E or S A E are n ot ca pt ure d 
i n t he C R F
All i nsta nces of E D P are 
re p orte d ( w het her or n ot 
t here is a n ass ociate d 
S A E) *
All i nsta nces of E D B are 
re p orte d ( w het her or n ot 
t here is a n ass ociate d S A E) 
* *
E n vir o n me ntal or 
occ u pati o nal e x p os ure 
t o t he pr o d uct u n der 
st u d y t o a n o n-
partici pa nt ( n ot 
i n v ol vi n g E D P or E D B)
N o ne. E x p os ure t o a st u d y 
n o n- partici pa nt is n ot 
c ollecte d o n t he C R F
T he e x p os ure ( w het her or 
n ot t here is a n ass ociate d 
A E or S A E) m ust be 
re p orte d * * *
* E D P ( wit h or wit h o ut a n ass ociate d A E or S A E): a n y pre g na nc y i nf or mati o n is re p orte d t o Pfizer 
Safet y usi n g t he C T S A E Re p ort F or m a n d E D P S u p ple me ntal F or m; if t he E D P is ass ociate d w it h 
a n S A E, t he n t he S A E is re p orte d t o Pfiz er Safet y usi n g t he C T S A E Re p ort F or m. 
* * E D B is re p orte d t o Pfizer Safet y usi n g t he C T S A E Re p ort F or m, w hic h w o ul d als o i ncl u de details 
of a n y S A E t hat mi g ht be ass ociate d w it h t he E D B. 
* * * E n vir o n me nt al or occ u p ati o n al e x p os ure: A E s or S A Es ass ociate d wit h occ u pati o nal e x p os ure 
are re p orte d t o Pfizer Safet y usi n g t he C T S A E Re p ort F or m.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 2

W he n a n A E or S A E occ urs, it is t he res p o nsi bilit y  of t he i n vesti gat or t o re vie w 
all d oc u me ntati o n (e g, h os pital pr o gress n otes, la b orat or y  re p orts, a n d dia g n ostic 
re p orts) relate d t o t he e ve nt.

T he i n vesti gat or will t he n rec or d all rele va nt A E or S A E i nf or mati o n i n t he C R F.

It is n ot acce pta ble f or t he i n vesti gat or t o se n d p h ot oc o pies of t he partici pa nt’s 
me dical rec or ds t o Pfizer Safet y  i n lie u of c o m pleti o n of t he C T S A E Re p ort 
F or m/ A E or S A E C R F pa ge.

T here ma y  be i nsta nces w he n c o pies of me dical rec or ds f or certai n cases are 
re q ueste d by Pfizer Safet y. I n t his case, all partici pa nt i de ntifiers, wit h t he 
e xce pti o n of t he partici pa nt n u m ber, wil l be re dacte d o n t he c o pies of t he me dical 
rec or ds bef ore s u b missi o n t o Pfizer Safet y.

T he i n vesti gat or will atte m pt t o esta blis h a dia g n osis of t he e ve nt base d o n si g ns, 
s ym pt o ms, a n d/ or ot her cli nical i nf or mati o n. W he ne ver p ossi ble, t he dia g n osis 
( n ot t he i n di vi d ual si g ns/s ym pt o ms) will be d oc u me nte d as t he A E or S A E.
Assess me nt of I nte nsit y
T he i n vesti gat or will ma ke a n assess me nt of i nte nsit y f or eac h A E a n d S A E re p orte d 
d uri n g t he st u d y a n d assi g n it t o 1 of t he cate g ories liste d bel o w (as defi ne d b y t he N CI 
C T C A E v 5. 0 s y ste m).
G R A D E
Cli nical Descri pti o n of I nte nsit y
1
MI L D A E
2
M O D E R A T E A E
3
S E V E R E A E
4
LI F E -T H R E A T E NI N G; ur ge nt i nter ve nti o n i n dicate d
5
D E A T H R E L A T E D T O A E
Assess me nt of C a us alit y

T he i n vesti gat or is o bli gate d t o assess t he relati o ns hi p bet wee n st u d y 
i nter ve nti o n a n d eac h occ urre nce of eac h A E or S A E. T he i n vesti gat or will use 
cli nical j u d g me nt t o deter mi ne t he relati o ns hi p.

A “reas o na ble p ossi bilit y” of a relati o ns hi p c o n ve ys t hat t here are facts, 
e vi de nce, a n d/ or ar g u me nts t o s u g gest a ca usal relati o ns hi p, rat her t ha n a 
relati o ns hi p ca n n ot be r ule d o ut.

Alter nati ve ca uses, s uc h as u n derl yi n g disease(s), c o nc o mita nt t hera p y, a n d ot her 
ris k fact ors, as well as t he te m p oral relati o ns hi p of t he e ve nt t o st u d y i nter ve nti o n 
a d mi nistrati o n, will be c o nsi dere d a n d i n vesti gate d.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 3

T he i n vesti gat or will als o c o ns ult t he I B a n d/ or pr o d uct i nf or mati o n, f or 
mar kete d pr o d ucts, i n t heir assess me nt.

F or eac h A E or S A E, t he i n vesti gat or m ust d oc u me nt i n t he me dical n otes t hat 
t he y ha ve re vie we d t he A E or S A E a n d ha ve pr o vi de d a n assess me nt of 
ca usalit y.

T here ma y  be sit uati o ns i n w hic h a n S A E has occ urre d a n d t he i n vesti gat or has 
mi ni mal i nf or mati o n t o i ncl u de i n t he i nitial re p ort t o t he s p o ns or. H o we ver, it is 
ver y i m p ort a nt t h at t he i n vesti g at or al w a ys m a ke a n assess me nt of c a us alit y 
f or e ver y e ve nt bef ore t he i niti al tr a ns missi o n of t he S A E d at a t o t he 
s p o ns or.

T he i n vesti gat or ma y  c ha n ge his/ her o pi ni o n of ca usalit y i n li g ht of f oll o w- u p 
i nf or mati o n a n d se n d a n S A E f oll o w-u p re p ort wit h t he u p date d ca usalit y  
assess me nt.

T he ca usalit y  assess me nt is o ne of t he criteria use d w he n deter mi ni n g re g ulat or y 
re p orti n g re q uire me nts.

If t he i n vesti gat or d oes n ot k n o w w het her or n ot t he st u d y i nter ve nti o n ca use d 
t he e ve nt, t he n t he e ve nt will be ha n dle d as “relate d t o st u d y i nter ve nti o n” f or 
re p orti n g p ur p oses, as defi ne d b y t he s p o ns or. I n a d diti o n, if t he i n vesti gat or 
deter mi nes t hat a n S A E is ass ociate d wit h st u d y  pr oce d ures, t he i n vesti gat or 
m ust r ec or d t his ca usal relati o ns hi p i n t he s o urce d oc u me nts a n d C R F, a n d re p ort 
s uc h a n assess me nt i n t he de dicate d secti o n of t he C T S A E Re p ort F or m a n d i n 
acc or da nce wit h t he S A E re p orti n g re q uire me nts.
F oll o w -U p of A Es a n d S A Es

T he i n vesti gat or is o bli gate d t o perf or m or arra n ge f or t he c o n d uct of 
s u p ple me ntal meas ure me nts a n d/ or e val uati o ns, as me dicall y i n dicate d or as 
re q ueste d by t he s p o ns or, t o el uci date t he nat ure a n d/ or ca usalit y of t he A E or 
S A E as f ull y  as p ossi ble. T his ma y i ncl u de a d diti onal la b orat or y  tests or 
i n vesti gati o ns, hist o pat h ol o gical e xa mi nati o ns, or c o ns ultati o n wit h ot her 
healt hcare pr o vi ders.

Ne w or u p date d i nf or mati o n will be rec or de d i n t he ori gi nall y  s u b mitte d 
d oc u me nts.

T he i n vesti gat or will s u b mit a n y  u p date d S A E data t o t he s p o ns or wit hi n 2 4 
h o urs of recei pt of t he i nf or mati o n.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 4
1 0. 3. 4. Re p orti n g of S A Es
S A E Re p orti n g t o Pfizer S afet y vi a a n Electr o nic D C T

T he pri mar y  mec ha nis m f or re p orti n g a n S A E t o Pfizer Safet y will be t he 
electr o nic D C T.

If t he electr o nic sys te m is u na vaila ble, t he n t he site will use t he pa per S A E D C T 
(see ne xt secti o n) t o re p ort t he e ve nt wit hi n 2 4 h o urs.

T he site will e nter t he S A E data i nt o t he electr o nic D C T (e g, e S A E or P S S A) or 
pa per f or m (as a p plica ble) as s o o n as t he data bec o me a vaila ble.

Af ter t he st u dy is c o m plete d at a gi ve n site, t he electr o nic D C T will be ta ke n 
off -li ne t o pre ve nt t he e ntr y of ne w data or c ha n ges t o e xisti n g data.

If a site recei ves a re p ort of a ne w S A E fr o m a st u d y partici pa nt or recei ves 
u p date d data o n a pre vi o usl y  re p orte d S A E after t he electr o nic D C T has bee n 
ta ke n off-li ne, t he n t he site ca n re p ort t his i nf or mati o n o n a pa per S A E f or m (see 
ne xt secti o n) or t o Pfizer Safet y  b y tele p h o ne.
S A E Re p orti n g t o Pfizer S afet y vi a t he C T S A E Re p ort F or m

Facsi mile tra ns missi o n of t he C T S A E Re p ort F or m is t he preferre d met h o d t o 
tra ns mit t his i nf or mati o n t o Pfizer Safet y.

I n circ u msta nces w he n t he facsi mile is n ot w or ki n g, a n alter nati ve met h o d s h o ul d 
be use d, e g, sec ure d ( Tra ns p ort L a yer Sec urit y) or pass w or d-pr ote cte d e mail. If 
n o ne of t hese met h o ds ca n be use d, n otificati o n b y tele p h o ne is acce pta ble wit h a 
c o p y of t he C T S A E Re p ort F or m se nt b y o ver ni g ht mail or c o urier ser vice.

I nitial n otificati o n via tele p h o ne d oes n ot re place t he nee d f or t he i n vesti gat or t o 
c o m plete a n d si g n t he C T S A E Re p ort F or m pa ges wit hi n t he desi g nate d 
re p orti n g ti me fra mes.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 5
1 0. 4. A p pe n di x 4: C o ntr ace pti ve a n d B arrier G ui d a nce 
F or c o ntrace pti o n g ui deli nes f or tafasita ma b a n d le nali d o mi de, refer t o t he l ocal prescri bi n g 
i nf or mati o n. In a d dit i o n, a n y P P P or ot her a p plica ble pr o gra m re q uire d per l ocal re g ulati o ns 
f or le nali d o mi de m ust be f oll o we d; details of t he P P P f or le nali d o mi de are i ncl u de d i n 
Secti o n 1 0. 4. 2 .
1 0. 4. 1. M ale P artici p a nt Re pr o d ucti ve I ncl usi o n Criteri a
Male partici pa nts are eli gi ble t o partici pate if t he y  a gree t o t he f oll o wi n g re q uire me nts d uri n g 
t he i nter ve nti o n peri o d a n d f or at least 4 wee ks after t he last d ose of le nali d o mi de, w hic h 
c orres p o n ds t o t he ti me nee de d t o eli mi nate re pr o d ucti ve safet y ris k of t he st u d y  
i nter ve nti o n(s): 

Refrai n fr o m d o nati n g s per m.
P L U S eit her:

Be a bsti ne nt fr o m heter ose x ual or h o m ose x ual i nterc o urse as t heir preferre d a n d us ual 
lifest yle (a bsti ne nt o n a l o n g-ter m a n d persiste nt basis) a n d a gree t o re mai n a bsti ne nt. 
O R

M ust a gree t o use a male c o n d o m w he n e n ga gi n g i n a n y  acti vit y t hat all o ws f or
passa ge of ejac ulate t o a n ot her pers o n e ve n after vasect o m y.

T he male partici pa nts s h o ul d be a d vise d of t he be nefit f or a W O C B P part ner usi n g a 
hi g hl y effecti ve met h o d of c o ntrace pti o n wit h a fail ure rate of < 1 % per ye ar, as descri be d 
i n Secti o n 1 0. 4. 4 .
I n t he e ve nt t hat a male partici pa nt has disc o nti n ue d t w o of t he 3 c o m bi nati o n t hera pies a n d 
re mai ns o n m o n ot hera py:  re q uire me nts are t o be c o nti n ue d for at least 4 wee ks after t he last 
d ose of le nali d o mi de m o n ot hera p y. N o c o ntrace pti o n or barrier meas ures are re q uire d f or 
male partici pa nts o n P F -0 7 9 0 1 8 0 1 or tafasita ma b.
1 0. 4. 2. Fe m ale P artici p a nt Re pr o d ucti ve I ncl usi o n Criteri a
T he criteria bel o w are part of I n cl usi o n Criteri o n N o. 1 ( A ge a n d Se x; Secti o n 5. 1 ) a n d 
s pecif y t he re pr o d ucti ve re q uire me nts f or i ncl u di n g fe male partici pa nts. Refer t o 
Secti o n 1 0. 4. 4 f or a c o m plete list of c o ntrace pti ve met h o ds per mitte d i n t he st u d y . 
A fe male partici pa nt is eli gi ble t o partici pate if s he (a) is n ot pre g na nt or breastfee di n g; a n d 
( b) a grees n ot t o d o nate e g gs ( o va, o oc ytes) f or t he p ur p ose of re pr o d ucti o n fr o m t he ti me of 
scree ni n g t hr o u g h 9 0 da ys after t he last d ose of st u d y  i nter ve nti o n; a n d (c) at least 1 of t he 
f oll o wi n g c o n diti o ns a p plies:

Is n ot a W O C B P (see defi niti o n i n Secti o n 1 0. 4. 3 ).
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 6
O R

Is a W O C B P a n d a grees t o use a c o ntrace pti ve met h o d t hat is hi g hl y  effecti ve (fail ure 
rate of < 1 % per year) wit h l o w user de pe n de nc y d uri n g t he i nter ve nti o n peri o d a n d 
a grees t o use it f or at least 9 0 da y s after t he last d ose of st u d y i nter ve nti o n, w hic h 
c orres p o n ds t o t he ti me nee de d t o eli mi nate a n y re pr o d ucti ve safet y ris k of t he st u d y 
i nter ve nti o n(s). T he i n vesti gat or s h o ul d e val uate t he effecti ve ness of t he 
c o ntrace pti ve met h o d i n relati o ns hi p t o t he first d ose of st u d y  i nter ve nti o n. 
O R

Is a W O C B P a n d a grees t o use a hi g hl y effecti ve (fail ure rate of < 1 % per year) user -
de pe n de nt met h o d of c o ntrace pti o n d uri n g t he i nter ve nti o n peri o d a n d f or at least 9 0 
da y s after t he last d ose of st u d y  i nter ve nti o n, w hic h c orres p o n ds t o t he ti me nee de d t o 
eli mi nate a n y re pr o d ucti ve safety ris k of t he st u d y i nter ve nti o n(s). I n a d diti o n t o her 
use of t he hi g hl y  effecti ve met h o d a b o ve, s he a grees t o c o nc urre ntl y use a n effecti ve 
barrier met h o d.  T he i n vesti gat or s h o ul d e val uate t he effecti ve ness of t he 
c o ntrace pti ve met h o d i n relati o ns hi p t o t he first d ose of st u d y i nter ve nti o n.
I n t he e ve nt t hat a W O C B P partici pa nt has disc o nti n ue d 2 of t he 3 c o m bi nati o n t hera pies a n d 
re mai ns o n m o n ot hera py:  t he c o ntrace pti ve met h o d m ust be use d f or at least 4 5 da ys after t he 
last d ose of P F-0 7 9 0 1 8 0 1 m o n ot hera p y , f or at least 2 8 da ys after t he last d ose of 
le nali d o mi de m o n ot hera p y a n d/ or f or at least 9 0 da ys after t he last d ose of tafasita ma b.
T he i n vesti gat or is res p o nsi ble f or re vi e w of me dical hist or y, me nstr ual hist or y, a n d rece nt 
se x ual acti vit y t o decrease t he ris k f or i ncl usi o n of a w o ma n wit h a n early u n detecte d 
pre g na nc y . T his is t o be d oc u me nte d i n t he s o urce d oc u me ntati o n. 
1 0. 4. 3. W o m a n of C hil d be ari n g a n d N o n -C hil d be ari n g P ote nti al
A w o ma n is c o nsi dere d fertile f oll o wi n g me narc he a n d u ntil bec o mi n g p ost me n o pa usal 
u nless per ma ne ntl y sterile (see bel o w).
If fertilit y is u nclear (e g, a me n orr hea i n a d olesce nts or at hletes) a n d a me nstr ual c ycle ca n n ot 
be c o nfir me d bef ore t he first d os e of st u d y i nter ve nti o n, a d diti o nal e val uati o n s h o ul d be 
c o nsi dere d.
W o me n i n t he f oll o wi n g cate g ories are n ot c o nsi dere d W O C B P:
1.
Pre me n o pa usal fe male wit h 1 of t he f oll o wi n g: 

D oc u me nte d h ys terect o m y;

D oc u me nte d bilateral sal pi n gect o m y ;

D oc u me nte d bilateral o o p h orect o m y.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 7
F or i n di vi d uals wit h per ma ne nt i nfertilit y  d ue t o a me dical ca use ot her t ha n t he a b o ve 
(e g, m ulleria n a ge nesis, a n dr o ge n i nse nsiti vit y), i n vesti gat or discreti o n s h o ul d be 
a p plie d t o deter mi ni n g st u d y e ntr y.
N ote: D oc u me ntati o n f or a n y  of t he a b o ve cate g ories ca n c o me fr o m t he site 
pers o n nel’s re vie w of t he partici pa nt’s me dical rec or ds, me dical e xa mi nati o n, or 
me dical hist or y  i nter vie w. T he met h o d of d oc u me ntati o n s h o ul d be rec or de d i n t he 
partici pa nt’s me dical rec or d f or t he st u d y.
2.
P ost me n o pa usal fe male:

A p ost me n o pa usal state is defi ne d as n o me nses f or 1 2 m o nt hs wit h o ut a n alter nati ve 
me dical ca use. I n a d diti o n, 

A hi g h F S H le vel i n t he p ost me n o pa usal ra n ge m ust be use d t o c o nfir m a 
p ost me n o pa usal state i n w o me n u n der 6 0 ye ars of age a n d n ot usi n g h or m o nal 
c o ntrace pti o n or H R T. 

A fe male o n H R T a n d w h ose me n o pa usal stat us is i n d o u bt will be re q uire d t o use 
o ne of t he hi g hl y  effecti ve n o n-estr o ge n h or m o nal c o ntrace pti o n met h o ds if s he 
wis hes t o c o nti n ue her H R T d uri n g t he st u d y. Ot h er wise, s he m ust disc o nti n ue 
H R T t o all o w c o nfir mati o n of p ost me n o pa usal stat us bef ore st u d y  e nr oll me nt.
1 0. 4. 4. C o ntr ace pti o n Met h o ds
C o ntrace pti ve use b y me n or w o me n s h o ul d be c o nsiste nt wit h l ocal a vaila bilit y /re g ulati o ns 
re gar di n g t he use of c o ntrace pti ve meth o ds f or t h ose partici pati n g i n cli nical trials.
I n a d diti o n, f or Le nali d o mi de, t he P P P a n d a n y ot her a p plica ble pr o gra m-re q uire d 
c o ntrace pti ve met h o ds m ust be f oll o we d ( w hic he ver is m ost stri n ge nt). T he P P P will be 
detaile d wit h t he Healt hcare Pr ofessi o na l/ Prescri ber P P P e d ucati o nal materials pr o vi de d t o 
t he sites. 
T he f oll o wi n g c o ntrace pti ve met h o ds are a p pr o priate f or t his st u d y :
Hi g hl y Effecti ve Met h o ds T hat Ha ve L o w User De pe n de nc y  
1.
I m pla nta ble pr o gest o ge n-o nl y  h or m o ne c o ntrace pti o n ass ociate d wit h i nhi biti o n 
of o v ulati o n.
2.
I ntra uteri ne de vice.
3.
I ntra uteri ne h or m o ne-releasi n g sys te m.
4.
Bilateral t u bal occl usi o n.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 8
5.
Vasect o mize d part ner.

Vasect o mize d part ner is a hi g hl y effecti ve c o ntrace pti ve met h o d pr o vi de d t hat 
t he part ner is t he s ole se x ual part ner of t he W O C B P a n d t he a bse nce of s per m 
has bee n c o nfir me d. If n ot, a n a d diti o nal hi g hl y effecti ve met h o d of 
c o ntrace pti o n s h o ul d be use d. T he s per mat o ge nesis c y cle is a p pr o xi matel y 
9 0 da y s.
Hi g hl y Effecti ve Met h o ds T hat Are User -De pe n de nt
6.
C o m bi ne d (estr o ge n - a n d pr o gest o ge n -c o ntai ni n g) h or m o nal c o ntrace pti o n 
ass ociate d wit h i n hi biti o n of o v ulati o n:

Oral + barrier *

I ntra va gi nal + barrier *

Tra ns der mal + barrier *
7.
Pr o gest o ge n - o nly h or m o ne c o ntrace pti o n ass ociate d wit h i n hi biti o n of o v ulati o n:

Oral + barrier *

I njecta ble + barrier *
Se x ual A bsti ne nce
8.
Se x ual a bsti ne nce is c o nsi dere d a hi g hl y effecti ve met h o d o nl y  if defi ne d as 
refrai ni n g fr o m heter ose x ual i nterc o urse d uri n g t he e ntire peri o d of ris k ass ociate d 
wit h t he st u d y  i nter ve nti o n. T he relia bilit y of se x ual a bsti ne nce nee ds t o be 
e val uate d i n relati o n t o t he d urati o n of t he st u d y a n d t he preferre d a n d us ual 
lifest yle of t he partici pa nt.
* Acce pta ble barrier met h o ds t o be use d c o nc o mita ntl y  wit h o pti o ns 6 or 7 f or t he st u d y 
i ncl u de a ny of t he f oll o wi n g:

Male or f e male c o n d o m wit h or wit h o ut s per mici de;

Cer vical ca p, dia p hra g m, or s p o n ge wit h s per mici de;

A c o m bi nati o n of male c o n d o m wit h eit her cer vical ca p, dia p hra g m or s p o n ge wit h 
s per mici de ( d o u ble-barrier met h o ds).
1 0. 4. 5. Le n ali d o mi de Pre g n a nc y Pre ve nti o n Pr o gr a m 
T h is secti o n c o ntai ns t he ge neral re q uire me nts of p ost-mar keti n g le nali d o mi de use t hat m ust 
be f oll o we d i n t his st u d y  i n a d diti o n t o a n y pr ot oc ol s pecific re q uire me nts. T he re q uire me nts 
ma y  sli g htl y differ fr o m c o u ntr y t o c o u ntr y, as a gree d wit h eac h Nati o nal C o m pete nt 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 9
A ut h orit y  or ot her Re g ulat or y A ge nc y. A P P P is a set of meas ures mea nt t o re d uce t o a 
mi ni m u m t he ris k of le nali d o mi de e x p os ure d uri n g pre g na nc y . T o a v oi d e m br yo- fetal 
e x p os ure, t he P P P m ust be i m ple me nte d. 
Ste ps t he He alt hc are Pr ofessi o n al m u st f oll o w f or t his pr ot oc ol:
1.
Recei ve Healt hcare Pr ofessi o nal/ Prescri ber P P P e d ucati o nal materials (as s u p plie d b y  t he 
S p o ns or a n d s pecific b y re gi o n);
2.
I nf or m t he partici pa nt re gar di n g t he be nefits a n d ris ks of treat me nt wit h le nali d o mi de, n ot 
s hari n g le nali d o mi de, n ot d o nati n g bl o o d, ris ks ass ociate d wit h fetal e x p os ure, a n d t he 
necessit y t o ta ke a de q uate meas ures t o a v oi d fetal e x p os ure t o le nali d o mi de;
3.
Gi ve t he partici pa nt t he a p pr o priate c orres p o n di n g e d ucati o nal br oc h ure (f or partici pa nts 
of c hil d beari n g p ote ntial, f or partici pa nts n ot of c hil d beari n g p ote ntial, or f or male 
partici pa nts) a n d c o u nsel t he partici pa nt o n c o ntrace pti o n re q uire me nts a n d e mer ge nc y  
c o ntrace pti o n use (i n c o u ntries w here a vaila ble);
4.
A p pl y  ste ps fr o m t he P P P al g orit h m (see Fi g ure 4 ). T he Healt hcare Pr ofessi o nal m ust 
e val uate t he partici pa nt fr o m a re pr o d ucti ve p ote ntial p oi nt of vie w pri or t o t he start of 
t he st u d y a n d e ver y 4 wee ks pri or t o dis pe nsi n g le nali d o mi de, t o e ns ure t hat:

Male partici pa nts are i nf or me d t hat t he y m ust use c o n d o ms if e n ga gi n g i n se x ual 
i nterc o urse wit h pre g na nt w o me n or w o me n of c hil d beari n g p ote ntial (e ve n if t he 
partici pa nt ha d a vasect o m y ) a n d m ust n ot d o nate s per m d uri n g le nali d o mi de 
treat me nt a n d f or 4 wee ks after cess ati o n of le n ali d o mi de .

Fe male partici pa nts m ust meet o ne of t he f oll o wi n g c o n diti o ns t o be c o nsi dere d of 
n o n -c hil d beari n g p ote ntial:
o
A ge d 5 0 + a n d nat urall y occ urri n g a me n orr hea of o ver 1 y ear (a me n orr hea t hat 
occ urre d as a res ult of c yt ostatic t hera p y or d uri n g breastfee di n g peri o d d oes 
n ot e xcl u de t he p ossi bilit y  t hat t he partici pa nt is fertile);
o
Pre mat ure o varia n fail ure t hat was c o nfir me d b y a g ynec ol o gist;
o
Bilateral sal pi n g o -o o p h orec t o my or h ys terect o my as part of me dical hist or y;
o
X Y ge n ot y pe, T ur ner s y n dr o me, uteri ne a ge nesis.

Fe male partici pa nts of c hil d beari n g p ote ntial m ust be i nf or me d of t he necessit y  
t o:
o
Utilize hi g hl y  effecti ve c o ntrace pti ve met h o d(s) as per t he P P P or ot her 
a pplica ble pr o gra m f or 4 wee ks bef ore treat me nt, d uri n g treat me nt, a n d f or 9 0 
da y s after c o m plete cessati o n of treat me nt   [ 4 wee ks after cessati o n is t he 
sta n dar d ti mi n g f or le nali d o mi de b ut n ote t hat a l o n ger d urati o n is re q uire d per 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 0
S m P C f or MI NJ U VI  (tafasita ma b)], i ncl u di n g d uri n g te m p orar y 
disc o nti n uati o n of treat me nt; or
o
T o mai ntai n t otal a n d c o nti n u o us a bsti ne nce; a n d
o
T o ta ke, u n der me dical s u per visi o n, pre g na nc y  tests wit h a se nsiti vit y of at 
least 2 5 mI U/ m L, after utilizi n g a n efficie nt c o ntrace pti ve meas ure f or at least 
4 wee ks, e ver y  4 wee ks (i ncl u di n g d uri n g te m p orar y disc o nti n uati o n of 
treat me nt), at E O T, a n d 4 wee ks after le nali d o mi de disc o nti n uati o n. T his als o 
i ncl u des w o me n of c hil d beari n g p ote ntial w h o practice t otal a n d c o nti n u o us 
a bsti ne nce.

D uri n g treat me nt bef ore le nali d o mi de is dis pe nse d:
o
F or fe male partici pa nts of c hil d beari n g p ote ntial, c o u nsel t he partici pa nt o n 
c o ntrace pti o n re q uire me nts a n d e mer ge nc y  c o ntrace pti o n use (i n c o u ntries 
w here a vaila ble) a n d e ns ure t hat t he re q uire d pre g na n c y test is ne gati ve. 
o
F or male partici pa nts, c o u nsel t he partici pa nt o n t he barrier c o ntrace pti o n 
re q uire me nts a n d e mer ge nc y c o ntrace pti o n use (i n c o u ntries w here a vaila ble).

D o n ot dis pe nse m ore t ha n a 2 8- d a y  s u p ply of le nali d o mi de.
F oll o w i nstr ucti o ns i n t he P P P e d ucati o nal materials if a pre g na nc y occ urs. 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 1
Fi g ure 4 .
Pre g n a nc y Pre ve nti o n Pl a n Al g orit h m
* 4 wee ks is t he sta n dar d ti mi n g f or t he P P P f or le nali d o mi de b ut n ote t hat a l o n ger d urati o n is re q uire d per 
pr ot oc ol f or tafasita ma b; see Secti o n 1 0. 4. 5 f or details re gar di n g m o n ot hera pies.
F or c o ntrace pti o n met h o ds, refer als o t o t he re gi o n- s pecific P P P e d ucati o nal materials as 
s u p plie d b y t he S p o ns or.  
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 2
1 0. 5. A p pe n di x 5: Ge netics
Use/ A n al ysis of D N A

Ge netic variati o n ma y  i m pact a partici pa nt’s res p o nse t o st u d y i nter ve nti o n, 
s usce pti bilit y t o, a n d se verit y a n d pr o gressi o n of disease. T heref ore, w here l ocal 
re g ulati o ns a n d I R Bs/ E Cs all o w, a bl o o d sa m ple will be c ollecte d f or D N A a nalys is.

T he sc o pe of t he ge netic researc h ma y  be narr o w (e g, 1 or m ore ca n di date ge nes) or 
br oa d (e g, t he e ntire ge n o me), as a p pr o priate t o t he scie ntific q uesti o n u n der 
i n vesti gati o n.

T he sa m ples ma y  be a nal yze d as part of a m ulti-st u d y assess me nt of ge netic fact ors 
i n v ol ve d i n t he res p o nse t o P F-0 7 9 0 1 8 0 1, tafasita ma b or le nali d o mi de or st u d y  
i nter ve nti o ns of t his class t o u n dersta n d treat me nts f or t he disease(s) u n der st u d y or 
t he disease(s) t he msel ves.

T he res ults of ge netic a nal y ses ma y be re p orte d i n t he C S R or i n a se parate st u d y 
s u m mar y or ma y be use d f or i nter nal decisi o n ma ki n g wit h o ut bei n g i ncl u de d i n a 
st ud y  re p ort.

T he s p o ns or will st ore t he D N A sa m ples i n a sec ure st ora ge s pace wit h a de q uate 
meas ures t o pr otect c o nfi de ntialit y . 

T he sa m ples will be retai ne d as i n dicate d:
o
Sa m ples f or s pecifie d ge netic a nal ys is (see Secti o n 8. 6. 1 ) will be st ore d f or u p t o 
1 5 y ears or ot her peri o d as per l ocal re q uire me nts be y o n d t he c o m pleti o n of t his 
st u d y (e g, C S R fi nalizati o n).
o
Retai ne d sa m ples will be st ore d i n defi nitel y  or f or a n ot her peri o d as per l ocal 
re q uire me nts.

Partici pa nts ma y  wit h dra w t heir c o nse nt f or t he st ora ge a n d/ or use of t heir Retai ne d 
Researc h Sa m ples at a n y ti me b y ma ki n g a re q uest t o t he i n vesti gat or; i n t his case, 
a n y re mai ni n g material will be destr o ye d. Data alrea d y ge nerate d fr o m t he sa m ples 
will be retai ne d t o pr otect t he i nte grit y of e xisti n g a nal ys es. 

Sa m ples f or ge netic researc h will be la bele d wit h a c o de. T he ke y  bet wee n t he c o de 
a n d t he partici pa nt ’s pers o nall y i de ntif yi n g i nf or mati o n (e g, na me, a d dress) will be 
hel d sec urel y at t he st u d y site. 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 3
1 0. 6. A p pe n di x 6: Li ver S afet y: S u g geste d Acti o ns a n d F oll o w -U p Assess me nts
P ote nti al C ases of Dr u g -I n d uce d Li ver I nj ur y
H u ma ns e x p ose d t o a dr u g w h o s h o w n o si g n of li ver i nj ur y  (as deter mi ne d b y ele vati o ns i n 
tra nsa mi nases) are ter me d “t olerat ors,” w hile t h ose w h o s h o w tra nsie nt li ver i nj ur y b ut a da pt 
are ter me d “a da pt ors.” I n s o me partici pa nts, tra nsa mi nase ele vati o ns are a har bi n ger of a 
m ore se ri o us p ote ntial o utc o me. T hese partici pa nts fail t o a da pt a n d t heref ore are 
“s usce pti ble” t o pr o gressi ve a n d seri o us li ver i nj ur y , c o m m o nly referre d t o as DI LI. 
Partici pa nts w h o e x perie nce a tra nsa mi nase ele vati o n a b o ve 3 × U L N s h o ul d be m o nit ore d 
m ore fre q ue ntl y  t o deter mi ne if t he y are “a da pt ors” or are “s usce pti ble.”
I n t he maj orit y of DI LI cases, ele vati o ns i n A S T a n d/ or A L T prece de T bili ele vati o ns 
( > 2 × U L N) b y  se veral da ys or wee ks. T he i ncrease i n T bili t ypicall y  occ urs w hile 
A S T/ A L T is/are still ele vate d a b o ve 3 × U L N (ie, A S T/ A L T a n d T bili val ues will be 
ele vate d wit hi n t he sa me la b orat or y  sa m ple). I n rare i nsta nces, b y t he ti me T bili ele vati o ns 
are detecte d, A S T/ A L T val ues mi g ht ha ve decrease d. T his occ urre nce is still re gar de d as a 
p ote ntial DI LI. T heref ore, a b n or mal ele vati o ns i n eit her A S T O R A L T i n a d diti o n t o T bili 
t hat meet t he criteria o utli ne d bel o w are c o nsi dere d p ote ntial DI LI (assesse d per H y’s la w 
criteria) cases a n d s h o ul d al wa y s be c o nsi dere d i m p orta nt me dical e ve nts, e ve n bef ore all 
ot her p ossi ble ca uses of li ver i nj ur y  ha ve bee n e xcl u de d.
T he t hres h ol d of la b orat or y  a b n or malities f or a p ote ntial DI LI case de pe n ds o n t he 
partici pa nt’s i n di vi d ual baseli ne val ues a n d u n derl yi n g c o n diti o ns. Partici pa nts w h o prese nt 
wit h t he f oll o wi n g la b orat or y  a b n or malities s h o ul d be e val uate d f urt her as p ote ntial DI LI 
( Hy’s la w) cases t o defi niti vel y  deter mi ne t he eti ol o g y of t he a b n or mal la b orat or y val ues:

Partici pa nts wit h A S T/ A L T a n d T bili baseli ne val ues wit hi n t he n or mal ra n ge w h o 
s u bse q ue ntly prese nt wit h A S T O R A L T val ues ≥3 × U L N A N D a T bili val ue 
≥2 × U L N wit h n o e vi de nce of he m ol ys is a n d a n al kali ne p h os p hatase val ue 
< 2 × U L N or n ot a vaila ble.
F or partici pa nts wit h baseli ne A S T O R A L T O R T bili val ues a b o ve t he U L N, t he f oll o wi n g 
t hres h ol d val ues are use d i n t he defi niti o n me nti o ne d a b o ve, as nee de d, de pe n di n g o n w hic h 
val ues are a b o ve t he U L N at baseli ne:

Pree xisti n g A S T or A L T baseli ne val ues a b o ve t he n or mal ra n ge: A S T or A L T val ues 
≥2 ti mes t he baseli ne val ues A N D ≥3 × U L N; or ≥8 × U L N ( w hic he ver is s maller).

Pree xisti n g val ues of T bili a b o ve t he n or mal ra n ge: T bili le vel i ncrease d fr o m 
baseli ne val ue b y a n a m o u nt of > 1 × U L N o r if t he val ue reac hes ≥3 × U L N 
( w hic he ver is s maller).
Rises i n A S T/ A L T a n d T bili se parate d b y m ore t ha n a fe w wee ks s h o ul d be assesse d 
i n di vi d uall y base d o n cli nical j u d g me nt; a n y case w here u ncertai nt y re mai ns as t o w het her it 
re prese nts a p ote ntial H y’s la w case s h o ul d be re vie we d wit h t he s p o ns or. 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 4
T he partici pa nt s h o ul d ret ur n t o t he i n vesti gat or site a n d be e val uate d as s o o n as p ossi ble, 
prefera bl y wit hi n 4 8 h o urs fr o m a ware ness of t he a b n or mal res ults. T his e val uati o n s h o ul d 
i ncl u de la b orat or y tests, detaile d hist or y, a n d p h ysical assess me nt. 
I n a d diti o n t o re peati n g meas ure me nts of A S T a n d A LT a n d T bi li f or s us pecte d H y’s la w 
cases, a d diti o nal la b orat or y  tests s h o ul d i ncl u de al b u mi n, C K, direct a n d i n direct bilir u bi n, 
G G T, P T/I N R, t otal bile aci ds, a n d al kali ne p h os p hatase. C o nsi derati o n s h o ul d als o be gi ve n 
t o dra wi n g a se parate t u be of cl otte d bl o o d a n d a n a ntic oa g ulate d t u be of bl o o d f or f urt her 
testi n g, as nee de d, f or f urt her c o nte m p ora ne o us a nal yses at t he ti me of t he rec o g nize d i nitial 
a b n or malities t o deter mi ne eti ol o g y . A detaile d hist or y, i ncl u di n g rele va nt i nf or mati o n, s uc h 
as re vie w of et ha n o l, aceta mi n o p he n/ paraceta m ol (eit her b y itself or as a c o-f or m ulate d 
pr o d uct i n prescri pti o n or o ver -t he-c o u nter me dicati o ns), recreati o nal dr u g, or s u p ple me nt 
( her bal) use a n d c o ns u m pti o n, fa mil y hist or y, se x ual hist or y, tra vel hist or y, hist or y of c o ntact
wit h a ja u n dice d pers o n, s ur ger y , bl o o d tra nsf usi o n, hist or y of li ver or aller gic disease, a n d 
p ote ntial occ u pati o nal e x p os ure t o c he micals, s h o ul d be c ollecte d. F urt her testi n g f or ac ute 
he patitis A, B, C, D, a n d E i nfecti o n, li ver i ma gi n g (e g, biliar y  tract), a n d c ollecti o n of ser u m 
sa m ples f or aceta mi n o p he n/ paraceta m ol dr u g a n d/ or pr otei n a d d uct le vels ma y be warra nte d. 
All cases de m o nstrate d o n re peat testi n g as meeti n g t he la b orat or y  criteria of A S T/ A LT a n d 
T bili ele vati o n defi ne d a b o ve s h o ul d be c o nsi dere d p ote ntial DI LI ( H y ’s la w) cases if n o 
ot her reas o n f or t he L F T a b n or malities has yet bee n f o u n d. S uc h p ote nti al DI LI ( H y’s l a w) 
c ases are t o be re p orte d as S A Es, irres pecti ve of a v ail a bilit y of all t he res ults of t he 
i n vesti g ati o ns perf or me d t o deter mi ne eti ol o g y of t he L F T a b n or m alities.
A p ote ntial DI LI ( H y ’s la w) case bec o mes a c o nfir me d case o nly after all res ults of 
reas o na ble i n vesti gati o ns ha ve bee n recei ve d a n d ha ve e xcl u de d a n alter nati ve eti ol o g y.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 5
1 0. 7. A p pe n di x 7: Ki d ne y S afet y: M o nit ori n g G ui deli nes
1 0. 7. 1. L a b or at or y Assess me nt of C h a n ge i n Ki d ne y F u ncti o n a n d Detecti o n of Ki d ne y 
I nj ur y
Sta n dar d ki d ne y  safet y m o nit ori n g re q uires assess me nt of baseli ne a n d p ost baseli ne ( Scr 
meas ure me nt t o e G F R [ Scr- base d e G F R]) or e Cr Cl. Baseli ne a n d p ost baseli ne Sc y s ma kes it 
feasi ble t o disti n g uis h A KI fr o m ot her ca uses of Scr i ncrease. If Scr i ncrease is c o nfir me d 
after baseli ne, t he n refle x meas ure me nt of Sc y s is i n dicate d t o esti mate t he c o m bi ne d 
Scr- S c y s e G F R calc ulati o n (f or a d ults o nly).
Re gar dless of w het h er ki d ne y f u ncti o n m o nit ori n g tests are re q uire d as a r o uti ne safety 
m o nit ori n g pr oce d ure i n t he st u d y , if t he i n vesti gat or or s p o ns or dee ms it necessar y t o f urt her 
assess ki d ne y safet y a n d q ua ntif y ki d ne y f u ncti o n, t he n t hese test res ults s h o ul d be ma na ged 
a n d f oll o we d per sta n dar d of care.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 6
1 0. 7. 2. A ge -S pecific Ki d ne y F u ncti o n C alc ul ati o n Rec o m me n d ati o ns
1 0. 7. 2. 1. A d ults ( 1 8 Ye ars a n d A b o ve) — 2 0 2 1 C K D- E P I E q u ati o ns3 4
2 0 2 1 C K D -
E PI            
Scr o nl y
Scr
( m g/ d L)
Sc ys
( m g/ L)
Rec o m me n de d e G F R E q u ati o n
Fe m ale
if ≤ 0. 7
N/ A
e G F R = 1 4 3 × ( Scr/ 0. 7) - 0. 2 4 1  ×  ( 0. 9 9 3 8) A ge
Fe m ale
if > 0. 7
N/ A
e G F R = 1 4 3 × ( Scr/ 0. 7) - 1. 2 0 0  ×  ( 0. 9 9 3 8) A ge
Male
if ≤ 0. 9
N/ A
e G F R = 1 4 2 × ( Scr/ 0. 9) - 0. 3 0 2  ×  ( 0. 9 9 3 8) A ge
Male 
if > 0. 9
N/ A
e G F R = 1 4 2 × ( Scr/ 0. 9) - 1. 2 0 0  ×  ( 0. 9 9 3 8) A ge
2 0 2 1 C K D -
E PI           
Scr- Sc ys 
C o m bi ne d
Scr
( m g/ d L)
Sc ys
( m g/ L)
Rec o m me n de d e G F R E q u ati o n
Fe m ale
if ≤ 0. 7
if ≤ 0. 8
e G F R = 1 3 0 × ( Scr/ 0. 7) - 0. 2 1 9  × ( Sc ys/ 0. 8) -0. 3 2 3  × 
( 0. 9 9 6 1)A ge
Fe m ale
if ≤ 0. 7
if > 0. 8
e G F R = 1 3 0 × ( Scr/ 0. 7) - 0. 2 1 9  × ( Sc ys/ 0. 8) -0. 7 7 8  × 
( 0. 9 9 6 1)A ge
Fe m ale
if > 0. 7
if ≤ 0. 8
e G F R = 1 3 0 × ( Scr/ 0. 7) - 0. 5 4 4  × ( Sc ys/ 0. 8) -0. 3 2 3  × 
( 0. 9 9 6 1)A ge
Fe m ale
if > 0. 7
if > 0. 8
e G F R = 1 3 0 × ( Scr/ 0. 7) - 0. 5 4 4  × ( Sc ys/ 0. 8) -0. 7 7 8  × 
( 0. 9 9 6 1)A ge
Male
if ≤ 0. 9
if ≤ 0. 8
e G F R = 1 3 5 × ( Scr/ 0. 9) - 0. 1 4 4  × ( Sc ys/ 0. 8) -0. 3 2 3  × 
( 0. 9 9 6 1)A ge
Male
if ≤ 0. 9
if > 0. 8
e G F R = 1 3 5 × ( Scr/ 0. 9) - 0. 1 4 4  × ( Sc ys/ 0. 8) -0. 7 7 8  × 
( 0. 9 9 6 1)A ge
Male 
if > 0. 9
if ≤ 0. 8
e G F R = 1 3 5 × ( Scr/ 0. 9) - 0. 5 4 4  ×  ( Sc ys/ 0. 8) -0. 3 2 3  × 
( 0. 9 9 6 1)A ge
Male 
if > 0. 9
if > 0. 8
e G F R = 1 3 5 × ( Scr/ 0. 9) - 0. 5 4 4  ×  ( Sc ys/ 0. 8) -0. 7 7 8  × 
( 0. 9 9 6 1)A ge
1 0. 7. 3. A d verse E ve nt Gr a di n g f or Ki d ne y S afet y L a b or at or y A b n or m alities
A E gra di n g f or decli ne i n ki d ne y  f u ncti o n (ie, e G F R or e Cr Cl) will be acc or di n g t o C T C A E 
criteria.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 7
1 0. 8. A p pe n di x 8: E C G Fi n di n gs of P ote nti al Cli nic al C o ncer n
E C G Fi n di n gs T h at M a y
Q u alif y as A Es

Mar ke d si n us bra d yc ar dia (rate < 4 0 b p m) lasti n g mi n utes.

Ne w P R i nter val pr ol o n gati o n > 2 8 0 ms.

Ne w pr ol o n gati o n of Q Tc F t o > 4 8 0 ms (a bs ol ute) or b y  ≥6 0 ms fr o m baseli ne.

Ne w -o nset atrial fl utter or fi brillati o n, wit h c o ntr olle d ve ntric ular res p o nse rate: 
ie, rate < 1 2 0 b p m.

Ne w -o nset t y pe I sec o n d de gree ( We nc ke bac h) A V bl oc k of > 3 0 sec o n ds’ d urati o n.

Fre q ue nt P V Cs, tri plets, or s h ort i nter vals ( < 3 0 sec o n ds) of c o nsec uti ve ve ntric ular 
c o m ple xes.
E C G Fi n di n gs T h at M a y
Q u alif y as S A Es

Q Tc F pr ol o n gati o n > 5 0 0 ms.

Ne w S T T c ha n ges s u g gesti ve of m y ocar dial isc he mia.

Ne w o nset L B B B ( Q R S c o m ple x > 1 2 0 ms).

Ne w -o nset ri g ht b u n dle bra nc h bl oc k ( Q R S c o m ple x > 1 2 0 ms).

S y m pt o matic bra d y car dia.

As y st ole:
o
I n a wa ke, sy m pt o m -free partici pa nts i n si n us r h yt h m, wit h d oc u me nte d peri o ds of 
as yst ole ≥3. 0 sec o n ds or a n y  esca pe rate < 4 0 b p m, or wit h a n esca pe r h yt h m t hat 
is bel o w t he A V n o de. 
o
I n a wa ke, sy m pt o m -free partici pa nts wit h atrial fi brillati o n a n d bra d ycardia wit h 
1 or m ore pa uses of at least 5 sec o n ds or l o n ger. 
o
Atrial fl utter or fi brillati o n, wit h ra pi d ve ntric ular res p o nse rate: ra pi d = rate 
> 1 2 0 b p m.

S ustai ne d s u pra ve ntric ular tac h yc ar dia (rate > 1 2 0 b p m) (“s ustai ne d” = s h ort d urati o n 
wit h rele va nt s y m p t o ms or lasti n g > 1 mi n ute).

Ve ntric ular r h yt h ms > 3 0 sec o n ds’ d urati o n, i ncl u di n g i di o ve ntric ular r h y t h m ( heart 
rate < 4 0 b p m), accelerate d i di o ve ntric ular r h y t h m ( H R > 4 0 b p m t o < 1 0 0 b p m), a n d 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 8
m o n o m or p hic/ p ol y m or p hic ve ntric ular tac h y car dia ( H R > 1 0 0 b p m [s uc h as t orsa des 
de p oi ntes]).

T y pe II sec o n d de gree ( M o bitz II) A V bl oc k.

C o m plete (t hir d de gree) heart bl oc k.
E C G Fi n di n gs T h at Q u alif y as S A Es

C ha n ge i n patter n s u g gesti ve of ne w m y ocar dial i nfarcti o n.

S ustai ne d ve ntric ular tac h y arr h yt h mias ( > 3 0 sec o n ds’ d urati o n).

Sec o n d or t hir d de gree A V bl oc k re q uiri n g pace ma ker place me nt.

As y st olic pa uses re q uiri n g pace ma ker place me nt.

Atrial fl utter or fi brillati o n wit h ra pi d ve ntric ular res p o nse re q uiri n g car di o versi o n.

Ve ntric ular fi brillati o n/fl utter.

At t he disc reti o n of t he i n vesti gat or, a ny arr h yt h mia classifie d as a n a d verse 
e x perie nce.
T he e n u merate d list of maj or e ve nts of p ote ntial cli nical c o ncer n are rec o m me n de d as “alerts” or 
n otificati o ns fr o m t he c ore E C G la b orat or y t o t he i n vesti gat or a n d Pfizer st u d y tea m, a n d n ot t o be 
c o nsi dere d as all -i ncl usi ve of w hat t o be re p orte d as A Es/ S A Es.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 9
1 0. 9. A p pe n di x 9: Pr o hi bite d C o nc o mit a nt Me dic ati o ns T h at M a y Res ult i n D DI
T here are c urre ntl y n o dr u gs i de ntifie d t o ha ve p ote ntial D DI c o ncer ns wit h P F - 0 7 9 0 1 8 0 1.
I n vesti gat ors s h o ul d c o ns ult t he S m P Cs f or tafasita ma b a n d le nali d o mi de as well as a ny 
n o n -I M P me dicati o n use d d uri n g t he st u dy f or i nf or mati o n re gar di n g me dicati o n t hat is 
pr o hi bite d f or c o nc o mita nt use.
T he Pfizer st u d y tea m is t o be n otifie d of a n y pr o hi bite d me dicati o ns ta ke n d uri n g t he st u d y . 
After c o ns ulti n g wit h t he s p o ns or, t he i n vesti gat or will ma ke a j u d g me nt o n t he o n g oi n g 
partici pati o n of a n y partici pa nt wit h pr o hi bite d me dicati o n use d uri n g t he st u d y.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 0
1 0. 1 0. A p pe n di x 1 0: C o u ntr y -S pecific Re q uir e me nts
1 0. 1 0. 1. Fr a nce 
C o ntrat U ni q ue
1.
G C P Trai ni n g
Bef ore e nr olli n g a n y partici pa nts, t he i n vesti gat or a n d a n y s u b -i n vesti gat ors will 
c o m plete t he Pfizer-pr o vi de d G o o d Cli nical Practice trai ni n g c o urse (“ Pfizer G C P 
Trai ni n g”) or trai ni n g dee me d e q ui vale nt b y Pfize r. A ny i n vesti gat ors w h o later j oi n 
t he st u d y will d o t he sa me bef ore perf or mi n g st u d y-relate d d uties. F or st u dies of 
a p plica ble d urati o n, t he i n vesti gat or a n d s u b -i n vesti gat ors will c o m plete Pfizer G C P 
Trai ni n g or e q ui vale nt e ver y  3 years d uri n g t he ter m of t he st u d y , or m ore ofte n if 
t here are si g nifica nt c ha n ges t o t he I CH G C P g ui deli nes or c o urse materials. 
2.
St u d y  Inter ve nti o n
N o partici pa nts or t hir d -part y  p a yers will be c har ge d f or st u d y i nter ve nti o n.
3.
Ur ge nt Safet y M eas ures 
I n a d diti o n, t he i n vesti gat or will i nf or m Pfizer i m me diatel y of a n y ur ge nt safety 
meas ures ta ke n b y t he i n vesti gat or t o pr otect t he st u d y  partici pa nts a gai nst a n y 
i m me diate hazar d, a n d of a n y seri o us breac hes of t his pr ot oc ol or of I C H G C P t hat 
t he i n vesti gat or bec o mes a ware of.
4.
Ter mi nati o n Ri g hts 
Pfizer retai ns t he ri g ht t o disc o nti n ue de vel o p me nt of P F - 0 7 9 0 1 8 0 1 at a n y t i me.
T he i n vesti gat or a grees t o a bi de b y t he et hical pri nci ples set f ort h i n t he W orl d Healt h 
Or ga nizati o n’s G ui di n g Pri nci ples f or H u m a n Cell, Tiss ue a n d Or g a n Tr a ns pl a nt ati o n 
( W H A 6 3. 2 2) wit h re gar d t o t he st u d y. 
( htt ps:// w w w. w h o.i nt/tra ns pla ntati o n/ G ui di n g _ Pri nci ples Tra ns pla ntati o n _ W H A 6 3. 2 2e n. p df)
1 0. 1 0. 2. J a p a n 
Ja pa n will partici pate i n P hase 1 b a n d P hase 2 after t he c o nfir mati o n of t olera bilit y of 
P F - 0 7 9 0 1 8 0 1 mo n ot hera p y  i n Ja pa nese partici pa nts.
F or all Ja pa nese partici pa nts, t he Ja pa n -s pecific P P P m ust be f oll o we d f or t he use of 
le nali d o mi de. In a d diti o n t o t he pr ot oc ol re q uire me nts ( A p pe n di x 4 ), t he f oll o wi n g criteria 
a n d pr oce d ures relate d t o t he Ja pa n -s pecific P P P are a p plie d f or Ja pa nese partici pa nts.
P hase 2 of t he st u d y will n ot be i nitiate d per b usi ness decisi o n ma de b y Pfizer ( pr ot oc ol 
a me n d me nt 2).
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 1
Defi niti o n of W o m a n of C hil d be ari n g a n d N o n -C hil d be ari n g P ote nti al
A w o ma n is c o nsi dere d fertile f oll o wi n g me narc he a n d u ntil bec o mi n g p ost me n o pa usal 
u nless per ma ne ntl y sterile (see bel o w).
If fertilit y is u nclear (e g, a me n orr hea i n a d olesce nts or at hletes) a n d a me nstr ual c ycle ca n n ot 
be c o nfir me d bef ore t he first d ose of st u d y i nter ve nti o n, a d diti o nal e val uati o n s h o ul d be 
c o nsi dere d.

W o me n i n t he f oll o wi n g cate g ories are n ot c o nsi dere d W O C B P:
1.
Pre me n o pa usal fe male wit h 1 of t he f oll o wi n g: 

D oc u me nte d h ys terect o m y;

D oc u me nte d bilateral o o p h orect o m y.
N ote: D oc u me ntati o n f or a n y  of t he a b o ve cate g ories ca n c o me fr o m t he site pers o n nel’s 
re vie w of t he partici pa nt’s me dical rec or ds, me dical e xa mi nati o n, or me dical hist or y 
i nter vie w. T he met h o d of d oc u me ntati o n s h o ul d be rec or de d i n t he partici pa nt’s me dical 
rec or d f or t he st u dy.
2.
P ost me n o pa usal stat us is defi ne d as n o me nses f or 2 4 m o nt hs wit h o ut a n alter nati ve 
me dical ca use (e g, a nti -t u m or t hera py). I n a d diti o n, 

A hi g h F S H le vel i n t he p ost me n o pa usal ra n ge m ust be use d t o c o nfir m a 
p ost me n o pa usal state i n w o me n u n der 6 0 ye ars of a ge a n d n ot usi n g h or m o nal 
c o ntrace pti o n or H R T. 

A fe male o n H R T a n d w h ose me n o pa usal stat us is i n d o u bt will be re q uire d t o use 
o ne of t he n o n -estr o ge n h or m o nal hi g hl y effecti ve c o ntrace pti o n met h o ds if t he y 
wis h t o c o nti n ue t heir H R T d uri n g t he st u d y. O t her wise, t he y m ust disc o nti n ue 
H R T t o all o w c o nfir mati o n of p ost me n o pa usal stat us bef ore st u d y  e nr oll me nt.
Re q uire d C o ntr ace pti ve Met h o d f or M ale P artici p a nts a n d Fe m ale P artici p a nts wit h 
C hil d be ari n g P ote nti al
Ja pa nese male partici pa nts m ust a gree t o c o nti n ue a bsti ne nce or use c o n d o ms re gar dless if 
vasect o mize d d uri n g t he re q uire d c o ntrace pti o n peri o d. T o miti gate ris k of e x p os ure t o fet us 
d uri n g pre g na nc y , male partici pa nts w h o ha ve a pre g na nt part ner are n ot eli gi ble f or t his 
st u d y.
F or Ja pa nese fe male partici pa nts, fe male partici pa nt wit h c hil d beari n g p ote ntial m ust a gree t o 
c o nti n ue a bsti ne nce or use 2 met h o ds t o e ns ure c o ntrace pti o n d uri n g t he re q uire d 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 2
c o ntrace pti o n peri o d. O ne s h o ul d be c h ose n fr o m pri mar y  met h o d a n d a n ot her s h o ul d be 
c h ose n fr o m seco n dar y  met h o d s h o w n bel o w. 

Pri mar y  met h o d
o
I ntra uteri ne de vice
o
H or m o nal c o ntrace pti o n ( oral, i njecta ble, i m pla nt, i ntra uteri ne h or m o ne releasi n g 
s yste m, D M P A [ de p ot me dr o x ypr o gester o ne acetate] i njecti o n, pr o gest o ge n -o nl y  
pill [e g, des o gestrel])
o
Bilateral t u bal occl usi o n (e g, bilateral t u bal li gati o n)
o
Vasect o mize d part ner

Sec o n dar y  met h o d
o
C o n d o m
o
Dia p hra g m
Re q uire d C o ntr ace pti o n Peri o d
Ja pa nese partici pa nts m ust i nitiate use of c o ntrace pti ve met h o d at least 2 8 da ys pri or t o t he 
first d ose of t he st u dy dr u g.
Sc he d ule Of Pre g n a nc y Test
F or Ja pa nese fe male partici pa nts wit h irre g ular me nstr ual c y cle, pre g na nc y test s h o ul d als o 
be perf or me d at Da y  1 5 of e ver y c ycle a n d 1 4 da ys after t he last d ose of le nali d o mi de i n 
a d diti o n t o t he ti mi n g desi g nate d i n t he S o A .
C o n diti o n t o be disc h ar ge d
W he n a partici pa nt is disc har ge d fr o m t he h os pital d uri n g t he D L T e val uati o n peri o d, t he 
f oll o wi n g c o n diti o ns (tests, me dical e xa mi nati o n, etc.) s h o ul d be perf or me d o n t he da y of t he 
sc he d ule d disc har ge by t h e i n vesti gat ors, a n d t he pr o priet y of disc har ge s h o ul d be 
deter mi ne d. T he tests/ me dical e xa mi nati o ns w hic h are nee de d t o c o nfir m t he partici pa nt’s 
stat us will be c o n d ucte d per cli nical practice i n t he st u d y site as a p pr o priate.

T here is n o c urre nt cli nical l y si g nifica nt a d verse or si de effects, i ncl u di n g c yt o ki ne 
release s yn dr o me, or me dical reas o ns t hat re q uires m o nit ori n g i n a h os pital setti n g.

If a cli nicall y si g nifica nt a d verse or si de effect has occ urre d or c o nti n ues t o be 
prese nt, t he i n vesti gat or has deter mi ne d t hat t he e ve nt is ma na gea ble b y a p pr o priate 
treat me nt or pr o p hyl a xis i n a n o ut of t he h os pital setti n g.

O verall p h ys ical c o n diti o n is sta ble a n d acce pta ble.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 3

I n case of e mer ge nc y, t he partici pa nt ma y ret ur n t o t he cli nical st u d y site or ot her 
me dical i nstit uti o n. If partici pa nts g o t o a me dical i nstit uti o n ot her t ha n t he cli nical 
st u d y site, t he cli nical st u d y site as ks t hat t he partici pa nts c o ntact t he st u d y site 
c o ntact i nf or mati o n a n d st u d y  i n vesti gat or a n d t he d oct or at t he me dical i nstit uti on 
will c o m m u nicate t o disc uss a p pr o priate treat me nts. A st u d y site kee ps fla me w or k t o 
rea dy f or e mer ge nc y sit uati o ns t hat is a vaila ble e ve n d uri n g ni g hts a n d h oli da ys, a n d 
t he s p o ns or will e ns ure t hat t he selecte d st u d y site will t h or o u g hl y f oll o w all 
part ici pa nts acc or di n g t o st u d y pr oce d ures.
H B V M o nit ori n g
F or t he S o A a n d Secti o n 8. 3. 4 Cli nical Safet y  La b orat or y Assess me nts, t he f oll o wi n g 
a d diti o nal la b orat or y H B V m o nit ori n g d uri n g st u d y i nter ve nti o n s h o ul d be f oll o we d as a 
preca uti o n:

F or partici pa nts wit h a p ositi ve H B s A b a n d p ositi ve H Bc A b test b ut wit h a ne gati ve 
H B V D N A test at Scree ni n g, H B viral l oa d s h o ul d be m o nit ore d f or re -acti vati o n 
e ver y 1 2 wee ks. If H B V rela pse is o bser ve d, t he e ve nt s h o ul d be c ollecte d i n t he A E 
secti o n of t he C R F, b ut t he test data will n ot be re q uire d t o be re p orte d o n t he C R F. 
Partici pa nts wit h a n H Bs A b p ositi ve test w h o ha ve bee n vacci nate d wit h H B V are 
e xe m pt fr o m t he testi n g of H B viral l oa d.

A d mi nistrati o n of st u d y  i nter ve nti o n will be i nterr u pte d f or a partici pa nt wit h a n H B V 
viral l oa d p ositi ve test at a n y ti me d uri n g t he st u d y. Starti n g n ucle osi de a nta g o nist 
a d mi nistrati o n i m me diatel y s h o ul d be c o nsi dere d i n parallel wit h c o ns ultati o n wit h a 
he pat ol o gist i n acc or da nce wit h t he Ja pa nese S ociet y  of He mat ol o g y ma na ge me nt of 
he patitis B vir us i nfecti o n. 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 4
1 0. 1 1. A p pe n di x 1 1: L u g a n o M o dific ati o n of A n n Ar b or St a gi n g S yste m ( f or Pri m ar y 
N o d al L y m p h o m as )2 7
St a ge
I n v ol ve me nt
E xtr a n o d al ( E) St at us
Li mite d
I
O ne n o de or gr o u p of a djace nt n o des
Si n gle e xtra n o dal lesi o ns
wit h o ut n o dal i n v ol ve me nt
II
T w o or m ore n o dal gr o u ps o n t he sa me si de of t he 
dia p hra g m
Sta ge I or II b y n o dal e xte nt wit h li mite d 
c o nti g u o us e xtra n o dal i n v ol ve me nt
II b ul k y *
II as a b o ve wit h “ b ul k y” disease
N ot a p plica ble
A d va nce d
III
N o des o n b ot h si des of t he dia p hra g m; n o des 
a b o ve t he dia p hra g m wit h s plee n i n v ol ve me nt
N ot a p plica ble
I V
A d diti o nal n o nc o nti g u o us e xtral y m p hatic 
i n v ol ve me nt
N ot a p plica ble
N O T E. E xte nt of disease is deter mi ne d b y p ositr o n e missi o n t o m o gra p h y – c o mp ute d t o m o gra p h y f or a vi d 
l y m p h o mas a n d c o m p ute d t o m o gra p h y f or n o n-a vi d hist ol o gies. T o nsils, Wal de yer’s ri n g, a n d s plee n are 
c o nsi dere d n o dal tiss ue.
* W het her sta ge II b ul k y disease is treate d as li mite d or a d va nce d disease ma y be deter mi ne d b y hist ol o g y 
a n d a n u m ber of pr o g n ostic fact ors.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 5
1 0. 1 2. A p pe n di x 1 2: L u g a n o Criteri a
Criteri a
C R
P R
P D
L u ga n o a, 2 7 ,3 5 ,3 6 ,3 7
P E T -C T, sc ore 1, 2, 
or 3 * wit h or w it h o ut 
a resi d ual mass o n 
5 P S † O R o n C T, 
tar get n o des/ n o dal 
masses m ust re gress 
t o ≤1. 5 c m i n L Di
P E T -C T sc ore 4 or 5 
wit h re d uce d u pta ke 
c o m pare d wit h 
baseli ne a n d resi d ual 
mass(es) of a n y size. 
O R O n C T ≥5 0 % 
decrease i n S P D of u p 
t o 6 tar get meas ura ble 
n o des a n d e xtra n o dal 
sites
P E T -C T sc ore 4 or 5 wit h a n i ncrease i n 
i nte nsit y of u pta ke fr o m baseli ne a n d/ or ne w 
F D G -a vi d f oci c o nsiste nt wit h l y m p h o ma at 
i nteri m or e n d-of -treat me nt assess me nt. O R O n 
C T, a n i n di vi d ual n o de/lesi o n m ust be 
a b n or mal wit h: L Di > 1. 5 c m  a n d i ncrease b y 
≥5 0 % f r o m P P D na dir a n d a n i ncrease i n L Di 
or S Di fr o m na dir 0. 5 c m f or lesi o ns ≤2 c m  
1. 0 c m f or lesi o ns > 2 c m
I n t he setti n g of s ple n o me gal y, t he s ple nic 
le n gt h m ust i ncrease b y > 5 0 % of t he e xte nt of 
its pri or i ncrease be y o n d baseli ne (e g, a 1 5 c m 
s plee n m ust increase t o > 1 6 c m). If n o pri or 
s ple n o me gal y, m ust i ncrease b y ≥2 c m  fr o m 
baseli ne. Ne w or rec urre nt s ple n o me gal y
Ne w  or clear pr o gressi o n of pre-e xisti n g n o n -
meas ure d lesi o ns
Re gr o wt h of pre vi o usl y res ol ve d lesi o ns
A ne w n o de > 1. 5 c m i n a n y a xis or a ne w 
e xtra n o dal site > 1. 0 c m  i n a n y a xis; if < 1. 0 c m  
i n a n y a xis, its prese nce m ust be u ne q ui v ocal 
a n d m ust be attri b uta ble t o l y m p h o ma
Assessa ble disease of a n y size u ne q ui v ocall y 
attri b uta ble t o l y m p h o ma
A N D/ O R ne w or rec urre nt i n v ol ve me nt of t he 
b o ne
marr o w
L Y RI C
Sa m e as L u ga n o
Sa m e as L u ga n o
As wit h L u ga n o wit h t he f oll o wi n g e xce pti o ns:
I R
I R( 1): ≥5 0 % i ncrease i n S P D i n first 1 2 we e ks
I R( 2): < 5 0 % i ncrease i n S P D wit h
a.
Ne w  lesi o n(s), or
b.
≥5 0 % i ncrease i n P P D of a lesi o n or set of 
lesi o ns at a n y ti me d uri n g treat me nt
I R( 3): I ncrease i n F D G u pta ke wit h o ut a 
c o nc o mita nt i ncrease i n lesi o n size meeti n g 
criteria f or P D
* A sc ore of 3 i n ma n y patie nts i n dicates a g o o d pr o g n osis wit h sta n dar d treat me nt, es peciall y if at t he ti me of a n i nteri m sc a n. 
H o we ver, i n trials i n v ol vi n g P E T w here de-escalati o n is i n vesti gate d, it ma y be prefera ble t o c o nsi der a sc ore of 3 as i na de q uate 
res p o nse (t o a v oi d u n dertreat me nt).
† P E T 5 P S: 1, n o u pta ke a b o ve bac k gr o u n d; 2, u pta ke ≤ me diasti n u m; 3, u pta ke > me diasti n u m b ut ≤ li ver; 4, u pta ke greater t ha n 
li ver; 5, u pta ke mar ke dl y hi g her t ha n li ver ( 2- 3 ti mes S U V ma x i n n or mal li ver) a n d/ or ne w lesi o ns; X, ne w areas of u pta ke 
u nli kel y t o be relate d t o l y m p h o ma.
a Efficac y assess me nts will be ma de acc or di n g t o t he P R o L o G C o nse ns us I nitiati ve f or Cli nical a n d Tec h nical clarificati o ns f or 
t he a p plicati o n of L u ga n o as re p orte d b y C hes o n et al., 2 0 1 42 7 , s u p porti ve p u blicati o ns Ricar d et al., 2 0 2 3 3 6 ,3 7
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 6
1 0. 1 3. A p pe n di x 1 3: E C O G Perf or m a nce St at us 3 8
Gr a de
Perf or m a nce st at us
0
F ull y  acti ve, a ble t o carr y o n all pre-disease perf or ma nce wit h o ut restricti o n
1
Restricte d i n p h y sicall y stre n u o us acti vit y b ut a m b ulat or y a n d a ble t o carr y o ut 
w or k of a li g ht or se de ntar y  nat ure, e. g., li g ht h o use w or k, office w or k
2  
A m b ul at or y a n d ca pa ble of all selfcare b ut u na ble t o carr y  o ut a ny w or k 
acti vities. U p a n d a b o ut m ore t ha n 5 0 % of wa ki n g h o urs
3
Ca pa ble of o nl y li mite d selfcare, c o nfi ne d t o be d or c hair m ore t ha n 5 0 % of 
wa ki n g h o urs
4
C o m pletel y  disa ble d. Ca n n ot carr y o n a n y selfcare. T otall y c o nfi ne d t o bed or 
c hair
5
Dea d
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 7
1 0. 1 4. A p pe n di x 1 4: I nter n ati o n al Pr o g n ostic I n de x (I PI)

a ge ol der t ha n 6 0

lactate de hy d r o ge nase le vel hi g her t ha n n or mal

E C O G perf or ma nce stat us sc ore of 2 or greater (see A p pe n di x 1 3 )

sta ge III or I V disease

m ore t ha n o ne i n v ol ve d e xtra n o dal disease site
T he I PI  gi ves o ne p oi nt f or eac h of t he a b o ve c haracteristics, f or a t otal sc ore ra n gi n g fr o m 
zer o t o fi ve c orrelati n g wit h t he f oll o wi n g ris k gr o u ps:

l o w ris k: 0– 1 p oi nts

l o w-i nter me diate ris k: 2 p oi nts

hi g h -i nter me diate ris k: 3 p oi nts

hi g h ris k: 4 – 5 p oi nts
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 8
1 0. 1 5. A p pe n di x 1 5: Pr ot oc ol A me n d me nt Hist or y
T he pr ot oc ol a me n d me nt s u m mar y  of c ha n ges ta ble f or t he c urre nt a me n d me nt is l ocate d 
directl y  bef ore t he T O C. T he pr ot oc ol a me n d me nt s u m mar y of c ha n ges ta bles f or past 
a me n d me nt(s) ca n be f o u n d bel o w:
A m e n d me nt 1 ( 1 4 M arc h 2 0 2 3)
O verall Rati o nale f or t he A me n d me nt: T he pri mar y p ur p ose of t his a me n d me nt is t o c ha n ge 
P hase 2 d osi n g of P F- 0 7 9 0 1 8 0 1 fr o m b o d y  wei g ht-base d t o a fi xe d d osi n g a p pr oac h. 
S u bsta ntial c ha n ges als o i m ple me nte d at t his ti me i ncl u de t he i ncl usi o n of HI V + partici pa nts 
f or P hase 2, re visi o ns t o t he c o ntrace pti o n re q uire me nt a n d pre g na nc y pre ve nti o n pla n 
la n g ua ge, a re visi o n t o t he d ose of per mitte d c ortic oster oi ds, a re d ucti o n i n E C G 
re q uire me nts, a n d a d de d refere nces t o P R o Lo G f or t he a p plicati o n of L u ga n o efficac y  
assess me nts.
Ot her c orrecti o ns or re visi o ns were ma de t o clarif y or m ore c o m pletel y defi ne pr ocesses.   
Descri pti o n of C h a n ge
Brief R ati o n ale  
Secti o n # a n d N a m e
S u bst a nti al M o dific ati o n(s)
F or P hase 2: HI V +: 
Partici pa nts wit h a n 
u n detecta ble viral l oa d a n d a 
C D 4 c o u nt ≥ 4 0 0 µ L are 
eli gi ble. F or HI V partici pa nts, 
C D 4 c o u nt a n d HI V viral l oa d 
a d de d t o t he S O A a n d la b 
assess me nts ( C D 4 a n d HI V 
viral l oa d t o be d oc u me nte d i n 
t he s o urce d oc u me nts, are n ot 
re q uire d i n t he C R F). Detail 
a d de d u n der ris k f or i nfecti o ns 
i n t he Secti o n: Ris k 
Assess me nt.
T o be i ncl usi ve of partici pa nts w it h 
c o ntr olle d HI V.  
Secti o n 1. 1 S y n o psis; Secti o n 1. 3 
Sc he d ule of Acti vities; Secti o n 
2. 3 . 1 Ris k Assess me nt; Secti o n 
5. 2 E xcl usi o n Criteria; Ta ble 1 3 
St u d y -S pecific Cli nical 
La b orat or y Assess me nts
E C G fre q ue nc y of c ollecti o n 
re d uce d.
T o si m plif y pr ot oc ol re q uire me nts. 
Tafasita ma b is u nli kel y t o ca use Q Tc 
pr ol o n gati o n per U S PI a n d S m P C a n d 
d ue t o t he nat ure of bei n g a m A b. T he 
E C G of P F - 0 7 9 0 1 8 0 1 is alrea d y 
s ufficie ntl y m o nit ore d at T ma x after 
t he first d ose a n d m ulti ple d oses at 
stea d y state, a n d a fe w pre-d ose 
sa m ples a n d as cli nicall y i n dicate d.
Secti o n 1. 3 Sc he d ule of 
Acti vities
Pre g na nc y Pre ve nti o n Pla n 
la n g ua ge u p date d t hr o u g h o ut 
t o re m o ve refere nce t o R E M S 
T o rec o ncile differi n g re gi o nal 
re q uire me nts; R E M S is n ot s pecificall y 
a p plica ble f or t his st u d y.            
Secti o n 2. 3. 1; Secti o n 1 0 . 4
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 9
Descri pti o n of C h a n ge
Brief R ati o n ale  
Secti o n # a n d N a m e
( Ris k E val uati o n Miti gati o n 
Strate g y).
M o difie d P hase 2 d osi n g of 
P F -0 7 9 0 1 8 0 1 fr o m b o d y 
wei g ht -base d t o a fi xe d d osi n g 
a p pr oac h.
T o har m o nize d osi n g of P F -0 7 0 1 8 0 1 
acr oss st u dies a n d i n dicati o ns

B o d y  wei g ht was n ot a si g nifica nt 
c o variate o n cleara nce i n t he 
P o p ulati o n P K m o del.

Fi xe d d osi n g pr o vi des a p ote ntial 
l o wer i nter -patie nt varia bilit y i n 
P K c o m pare d t o B W T base d 
d osi n g.   
Secti o n 4. 3. 1 D osi n g Re gi me ns 
of P F -0 7 9 0 1 8 0 1
Per m itte d use of s yste mic 
c ortic oster oi ds has bee n 
re d uce d fr o m ≤2 0 m g/ da y t o 
≤1 0 m g/ da y of pre d nis o ne or 
e q ui vale nt.
T o mi ni mize p ote ntial c o nf o u n di n g 
effects of ster oi ds o n disease u n der 
st u d y.
Secti o n 5. 2 E xcl usi o n criteria; 
Secti o n 6. 9. 5 C ortic oster oi ds
F or t he a d mi nistrati o n of P F -
0 7 9 0 1 8 0 1, a d de d detail t o t he 
se nte nce t hat pre me dicati o ns 
are n ot re q uire d f or P F -
0 7 9 0 1 8 0 1: ‘ b ut ma y be 
a d mi nistere d per i nstit uti o nal 
g ui deli nes at t he i n vesti gat or’s 
discreti o n a n d/ or if a pri or 
I R R has bee n e x perie nce d’ 
a n d a d de d detail re gar di n g t he 
o bser vati o n peri o d: ‘ F or at 
least t he first 4 i nf usi o ns of 
P F -0 7 9 0 1 8 0 1, t he partici pa nt 
is t o re mai n i n t he cli nic f or 
o bser vati o n f or at least 1 h o ur 
after t he i nf usi o n (a n d t his 1 
h o ur m ust c o m plete pri or t o 
starti n g t he s u bse q ue nt 
tafasita ma b i nf usi o n).’      
F or t he a d mi nistrati o n of 
tafasita ma b, t he se nte nce 
‘ A p pr o xi matel y 6 0 mi n utes
m ust ela pse after t he 
c o m pleti o n of P F -0 7 9 0 1 8 0 1 
pri or t o t he start of t he 
i nf usi o n of tafasita ma b' has 
bee n delete d. 
T o clarif y a d mi nistrati o n of 
pre me dicati o ns a n d o bser vati o n peri o d 
f or P F-0 7 9 0 1 8 0 1.    
Secti o n 2. 3. 1; Secti o n 6. 1. 1. 1 P F -
0 7 9 0 1 8 0 1; Secti o n 6. 1. 1. 2 
Tafasita ma b
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 0
Descri pti o n of C h a n ge
Brief R ati o n ale  
Secti o n # a n d N a m e
A ‘ user-de pe n de nt’ met h o d 
( wit h barrier) was a d de d t o 
t he c urre ntl y m ore restricti ve 
( hi g hl y effecti ve, n o n-user 
de pe n de nt) la n g ua ge. 
F or greater i ncl usi o n of w o m e n of 
c hil d-beari n g p ote ntial, a ‘ user -
de pe n de nt’ met h o d ( w it h barrier) is 
a d de d t o t he c urre ntl y m ore restricti ve 
( hi g hl y effecti ve, n o n-user de pe n de nt) 
la n g ua ge. T his better c orres p o n ds wit h 
p ote ntial re gi o n -s pecific le nali d o mi de 
pre g na nc y pre ve nti o n pr o gra ms a n d 
pr o vi des a p pr o priate o pti o ns f or 
w o me n after t he c o m pl eti o n of 
le nali d o mi de b ut c o nti n ui n g ot her 
st u d y dr u gs.    
Secti o n 1 0. 4. 2 Fe male Partici pa nt 
Re pr o d ucti ve I ncl usi o n Criteria
A d de d: I n a d diti o n, f or 
Le nali d o mi de t he Pre g na nc y 
Pre ve nti o n Pla n ( P P P) a n d 
a n y ot her a p plica ble pr o gra m 
re q uire d c o ntrace pti ve 
met h o ds m ust be f oll o we d 
( whic he ver is m ost stri n ge nt).
T o clarif y t hat t he m ost stri n ge nt 
c o ntrace pti ve met h o d (rele va nt f or t he 
re gi o n) m ust be f oll o we d.
Secti o n 1 0. 4. 4 C o ntrace pti o n 
Met h o ds
A d de d la n g ua ge: F or 
c o ntrace pti o n met h o ds, refer 
als o t o t he r e gi o n -s pecific P P P 
e d ucati o nal materials as 
s u p plie d b y t he S p o ns or.  
T o clarif y t hat P P P e d ucati o nal 
materials will be s u p plie d b y t he 
S p o ns or a n d will be s pecific b y re gi o n.
Secti o n 1 0. 4. 5, Fi g ure 4. 
Pre g na nc y Pre ve nti o n Pla n 
Al g orit h m
Utilizati o n of ‘tw o  effecti ve 
c o ntrace pti ve met h o ds’ has 
bee n re vise d t o ‘ hi g hl y 
effecti ve c o ntrace pti o n 
met h o d(s) as per t he P P P or 
ot her a p plica ble pr o gra ms …’
T o rec o ncile differi n g re gi o nal 
re q uire me nts.            
Secti o n 1 0. 4. 5 Le nali d o mi de 
Pre g na nc y Pre ve nti o n Pr o gra m
N otes u p date d f or 
retic ul oc ytes: t o be perf or me d 
at baseli ne; cli nicall y 
i n dicate d is n o w defi ne d as 
w he n t here is ≥ Gra de 2 
a ne mia).
T o pr o vi de a baseli ne f or e ve nt ual later 
a b n or mal res ults.
Ta ble 1 3 St u d y -S pecific Cli nical 
La b orat or y Assess me nts
A d de d: ‘ Efficac y assess me nts 
will be ma de acc or di n g t o t he 
P R o L o G C o nse ns us I nitiati ve 
f or Cli nical a n d Tec h nical 
clarificati o ns f or t he 
a p plicati o n of L u ga n o  as 
re p orte d b y C hes o n et al., 
2 0 1 4 , s u p p ortive p u blic ati o ns
Ric ar d et al., 2 0 2 3 )’
T o i ncl u de refere nce t o t he P R o L o G 
g ui da nce d oc u me nts w hic h pr o vi de 
g ui da nce f or c o nsiste nt a p plicati o n of 
t he L u ga n o classificati o n. 
A p pe n di x 1 2: L u ga n o Criteria
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 1
Descri pti o n of C h a n ge
Brief R ati o n ale  
Secti o n # a n d N a m e
N o n -S u bst a nti al M o dific ati o n(s)
Pr ot oc ol s y n o psis was 
s h orte ne d, t he ta ble ‘ St u d y 
I nter ve nti o ns Classifie d as 
NI M Ps/ A x M Ps’a n d t he 
secti o n Et hical C o nsi derati o ns 
were als o a d de d t o t he 
s y n o psis. 
T o c o m pl y wit h re g ulat or y 
re q uire me nts c o ncer ni n g le n gt h of 
pr ot oc ol s y n o psis. 
Secti o n 1. 1 S y n o psis
U p date d ‘ E B V p ositi ve 
D L B C L of t he el derl y’ t o 
‘ E B V p ositi ve D L B C L’, 
‘ d o u ble’ or ‘tri ple hit’ 
D L B C L u p date d t o ‘ Hi g h -
gra de l y m p h o ma (f or merl y 
k n o w n as ‘ d o u ble or ‘tri ple 
hit’ D L B C L)’ a n d t he 
refere nce d (c urre nt) e diti o n of 
t he W H O classificati o n 
ad de d; C N S l y m p h o ma 
clarifie d as ‘i n v ol ve me nt –
prese nt or past me dical 
hist or y’ 
T o be c o nsiste nt wit h t he m ost rece nt 
W H O Classificati o n of L y m p h oi d 
Ne o plas ms.  
Secti o n 1. 1 S y n o psis; Secti o n 5. 1 
I ncl usi o n Criteria
E xcl usi o n of acti ve G V H D 
has bee n delet e d
T o si m plif y e nr ol lme nt criteria; acti ve 
G V H D is n ot e x pecte d t o be rele va nt i n 
t his p o p ulati o n ( pri or all o ge neic 
tra ns pla nt is e xcl u de d).
Secti o n 1. 1 S y n o psis; Secti o n 5. 2 
E xcl usi o n Criteria
Dia g n ostic C T sca n a d de d t o 
E n d of Treat me nt a n d i n 
pare nt hesis at L T F U o n t he 
S O A 
T o c orrect pre vi o us o missi o n; C T sca n 
is als o t o be c ollecte d at e n d of 
treat me nt i ma gi n g t o get her wit h P E T, 
a n d is re q uire d d uri n g L T F U if/ w he n a 
partici pa nt is disc o nti n u e d pri or t o 
pr o gressi o n.  
Secti o n 1. 3 Sc he d ule of 
Acti vities; Secti o n 8. 1. 2 F oll o w -
u p Visits a n d L T F U
A d de d detail re gar di n g 
sa m ple a n d pla n ne d use, 
t o get her wit h bl o o d bi o mar ker 
sa m ples, f or s pecifie d ge netic 
researc h
T o clarif y t hat
bi o m ar ker 
sa m ples ma y als o be use d f or s pecifie d 
ge netic researc h.
Secti o n 1. 3 Sc he d ule of 
Acti vities, Secti o ns 8. 7 
Bi o mar kers, 8. 7. 6 
 Sa m ple 
f or Matc he d C o ntr ol a n d 
S pecifie d Ge netic Researc h
A d de d detail t o t he se nte nce 
t hat I nf usi o n Relate d Reacti o n 
(I R R) has n ot bee n pre vale nt 
‘ w he n a d mi nistere d wit h 
pre me dicati o ns’ 
T o clarif y a vaila ble data re gar di n g 
i nf usi o n relate d reacti o ns.
Secti o n 2. 3. 1
A d de d t o cli nical 
p har mac ol o g y secti o n details 
T o pr o vi de m ore c o m p re he nsi ve detail 
re gar di n g a nti-tafasita ma b a nti b o dies  
Secti o n 2. 3. 3. 2
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)
C CI
C CI
C CI

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 2
Descri pti o n of C h a n ge
Brief R ati o n ale  
Secti o n # a n d N a m e
re gar di n g a nti-tafasita ma b 
a nti b o dies
A d de d details t o t he 
car di o vasc ular e xcl usi o n 
criteri o n.
T o better clarif y 
car diac/car di o vasc ular/t hr o m b oe m b olic 
e xcl usi o n la n g ua ge, i ncl u di n g t he n o n -
e xcl usi o n of atrial fi brillat i o n.
Secti o n 5. 2 E xcl usi o n Criteria
A d de d la n g ua ge t hat 
e q ui vale nt pre me dicati o ns 
i ncl u de variati o ns t o t he state d 
d ue t o t he f or m ulati o ns 
a vaila ble l ocall y a n d or i n 
acc or da nce wit h i nstit uti o nal 
g ui deli nes.
T o clarif y t hat e q ui vale nt 
pre me dicati o ns t o t h ose s pecifie d ma y 
be use d. 
Secti o n 6. 0, Ta ble 5 St u d y 
I nter ve nti o ns Classifie d as 
NI M Ps/ A x M Ps; Secti o n 6. 1. 1. 2 
Tafasita ma b
A d de d detail t o i nstr ucti o n 
re gar di n g misse d d oses of 
Le nali d o mi de.
T o pr o vi de f urt her clarificati o n, as 
fr o m t he pr o d uct S m P C.
Se cti o n 6. 1. 1. 3 Le nali d o mi de
A d de d detail ‘ra di o gra p hic 
i ma ges utilize d f or efficac y 
assess me nts ma y be c ollecte d 
a n d st ore d b y a n i n de pe n de nt 
t hir d part y i ma gi n g 
la b orat or y, (see I ma gi n g 
Ma n ual f or details).’
T o clarif y t hat sca ns ma y be c ollecte d 
a n d st ore d b y a t hir d part y i ma gi n g 
la b orat or y.
Secti o n 8. 2 Efficac y Assess me nts
A d de d detail re gar di n g 
o pti o ns f or C T sca n c o ntrast: 
a b d o mi nal a n d pel vic C T 
sca ns s h o ul d be perf or me d 
wit h oral or I V c o ntrast. 
T o clarif y t hat I V c o ntrast ma y als o be 
use d f or a b d o mi nal or pel vic C T sca ns. 
Secti o n 8. 2. 1 C o m p ute d 
T o m o gra p h y Sca ns
S y m b ol c orrecti o n: fe vers of 
3 8. 0° C, n ot ≥3 8. 0° C.
T o c orrect t he defi niti o n of B -
S y m pt o ms.
Secti o n 8. 3. 6 B -S y m pt o ms
Delete d n ote f or W B C 
differe ntial: ‘ Perce nt t o be 
c ollecte d o nl y if a bs ol ute 
val ues are n ot a vaila ble.’
Alter nati ve la b a P T T has bee n 
a d de d.
T o clarif y t hat perce nt will n ot be a n 
o pti o n i n t he C R F. Sites wit h o ut 
a bs ol ute val ues will calc ulate t he 
a bs ol ute val ues as per i nstr ucti o ns i n 
t he C R F C o m pleti o n G ui da nce 
d oc u m e nt.
T o pr o vi de m ore fle xi bilit y f or sites.
Ta ble 1 3 St u d y -S pecific Cli nical 
La b orat or y Assess me nts
Mi n or u p dates a n d 
clarificati o ns
Mi n or u p dates or clarificati o ns w ere 
ma de f or acc urac y a n d c o nsiste nc y.
T hr o u g h o ut pr ot oc ol
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 3
1 0. 1 6. A p pe n di x 1 6: A b bre vi ati o ns
T he f oll o wi n g is a list of a b bre viati o ns t hat ma y  be use d i n t he pr ot oc ol. 
A b bre vi ati o n
Ter m
~
a p pr o xi matel y
%
perce nt or perce nta ge
5 P S
5 -p oi nt scale
A b
a nti b o d y
A D A
a nti dr u g a nti b o dies
A D C C
a nti b o d y-de pe n de nt cell -me diate d c yt ot o xicit y
A D C P
a nti b o d y-de pe n de nt cell -me diate d p ha g oc y t osis
A E
a d verse e ve nt
AI D S
ac q uire d i m m u n o deficie nc y  sy n dr o me
A KI
ac ute ki d ne y i nj ur y
A L P
al kali ne p h os p hatase
A L T
ala ni ne a mi n otra nsferase
A M L
ac ute m yel oi d le u ke mia
A N C
a bs ol ute ne utr o p hil c o u nt
a P T T
acti vate d partial t hr o m b o plasti n
A S C O
A merica n S ociet y of Cli nical O nc ol o g y
A S C T
a ut ol o g o us ste m cell tra ns pla ntati o n
A S T
as partate a mi n otra nsferase
A S T C T
T he A merica n S ociet y f or Tra ns pla ntati o n a n d Cell ular T hera p y
A U C
area u n der t he c ur ve
A V
atri o ve ntric ular
A x M P
a u xiliar y me dici nal pr o d uct
B C L
B -cell l ym p h o ma
B O R
best o verall res p o nse
B P
bl o o d press ure
b p m
beats per mi n ute
B R
best res p o nse
B W T
b o d y  wei g ht
C #
C y cle 1, 2, 3, etc.
C A R -T
c hi meric a nti ge n rece pt or T -cell
C B C
c o m plete bl o o d c o u nt
C D C
Ce nter f or Disease C o ntr ol
C F R
C o de of Fe deral Re g ulati o ns
CI
c o nfi de nce i nter val
CI O M S
C o u ncil f or I nter nati o nal Or ga nizati o ns of Me dical Scie nces
C K
creati ne ki nase
C K D
c hr o nic ki d ne y disease
C ma x
ma xi m u m o bser ve d c o nce ntrati o n
C N S
ce ntral ner v o us s ys te m
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)
C CI

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 4
A b bre vi ati o n
Ter m
C O N S O R T
C o ns oli date d Sta n dar ds of Re p orti n g Trials
C O VI D -1 9
c or o na vir us disease 2 0 1 9
C R
c o m plete res p o nse
Cr Cl
creati ni ne cleara nce
C R F
case re p ort f or m
C R O
c o ntract researc h or ga nizati o n
C R S
c yt o ki ne release sy n dr o me
C R R
c o m plete res p o nse rate
C S R
Cli nical St u d y  Re p ort
C T
c o m p ute d t o m o gra p h y/ cli nical trial
C T C A E
C o m m o n Ter mi n ol o g y  Criteria f or A d verse E ve nts
C T C L
c uta ne o us T -cell l ym p h o ma
C TI S
Cli nical Trial I nf or mati o n S y ste m
C V
c oefficie nt of variati o n
D #
D a y  1, 2, 3, etc.
D C T
data c ollecti o n t o ols
D DI
dr u g -dr u g i nteracti o n
DI LI
dr u g -i n d uce d li ver i nj ur y
D L
d ose le vel
D L B C L
diff use lar ge B cell l y m p h o ma
D L R
D ose Le vel Re vie w 
D L T
d ose -li miti n g t o xicit y
D o C R
d urati o n of c o m plete res p o nse
D o R
d urati o n of res p o nse
D R E S S
dr u g reacti o n wit h e osi n o p hilia a n d s y ste mic sy m pt o ms
D U
dis pe nsa ble u nit
D V T
dee p vei n t hr o m b osis
E B V
E pstei n -Barr vir us
E C
et hics c o m mittee
E C G
electr ocar di o gra m 
Ec h o
ec h ocar di o gra m
E C O G
Easter n C o o perati ve O nc ol o g y  Gr o u p
e Cr Cl
esti mate d creati ni ne cleara nce
e C R F
electr o nic case re p ort f or m
E D B
e x p os ure d uri n g breastfee di n g
E D P
e x p os ure d uri n g pre g na nc y
E -D M C
E xter nal Data M o nit ori n g C o m mittee
e G F R
esti mate d gl o mer ular filtrati o n rate
EI
E q ui vale nce I nter val
E OI
e n d of i nf usi o n
E O T
e n d of treat me nt
E PI
E pi de mi ol o g y  C olla b orati o n
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)
C CI

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 5
A b bre vi ati o n
Ter m
e S A E
electr o nic seri o us a d verse e ve nt
E U
E ur o pea n U ni o n
E U C T
E ur o pea n U ni o n Cli nical Trials
E u dra C T
E ur o pea n U ni o n Dr u g Re g ulati n g A ut h orities Cli nical Trials ( E ur o pea n 
Cli nical Trials Data base)
Fc
fra g me nt of t he i m m u n o gl o b uli n t hat is e nc o de d b y c o nsta nt (c) ge nes
Fc R
Fc rece pt or
Fc R n
ne o natal Fc rece pt or
F D G
fl u or o de o xy gl uc ose
F F P E
f or mali n-fi xe d paraffi n-e m be d de d
FI H
first-i n-h u ma n
FI S H
Fl u oresce nce i n sit u h y bri dizati o n
F L
f ollic ular l ym p h o ma
F S H
f ollicle-sti m ulati n g h or m o ne
F U
f oll o w-u p
G #
C T C A E Gra de 1, 2, etc
G C P
G o o d Cli nical Practice
G -C S F
gra n ul oc y te c ol o ny -sti m ulati n g fact or,
G G T
ga m ma -gl uta m y l tra nsferase
G V H D
graft -vers us -h ost disease
H Bc A b
he patitis B c ore a nti b o d y
H Bs A b
he patitis B s urface a nti b o d y
H Bs A g
he patitis B s urface a nti ge n
H B V
he patitis B vir us
H C V
he patitis C vir us
HI V
h u ma n i m m u n o deficie nc y vir us
H L
H o d g ki n l y m p h o ma
H R
hazar d rati o, heart rate
H R T
h or m o ne re place me nt t hera p y
I B
I n vesti gat or’s Br oc h ure
I C D
i nf or me d c o nse nt d oc u me nt
I C H
I nter nati o nal C o u ncil f or Har m o nisati o n of Tec h nical Re q uire me nts f or 
P har mace uticals f or H u ma n Use
I D
i de ntificati o n
I g A
i m m u n o gl o b uli n A
I g G
i m m u n o gl o b uli n G
I g M
i m m u n o gl o b uli n M
I Mi D
i m m u n o m o d ulat or y i mi de dr u g
I M P
i n vesti gati o nal me dici nal pr o d uct
I ND
I n vesti gati o nal Ne w Dr u g
I N R
i nter nati o nal n or malize d rati o
I P
i n vesti gati o nal pr o d uct
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)
C CI

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 6
A b bre vi ati o n
Ter m
I P A L
I n vesti gati o nal Pr o d uct Acc o u nta bilit y L o g
I PI
I nter nati o nal Pr o g n ostic I n de x
I R
i m m u ne res p o nse
I RB
I nstit uti o nal Re vie w B oar d
I R R
i nf usi o n relate d reacti o n
I R T
I nteracti ve Res p o nse Tec h n ol o g y
I V
i ntra ve n o us
L B B B
left b u n dle bra nc h bl oc k
L D H
lactate de hy d r o ge nase
L Di
l o n gest dia meter
L F T
li ver f u ncti o n test
L T F U
L o n g -Ter m F oll o w -U p
L V E F
left ve ntric ular ejecti o n fracti o n
Me d D R A
Me dical Dicti o nar y  f or Re g ulat or y Acti vities
M D R
Me dical De vice Re g ulati o n
M M
m ulti ple m y el o ma
M o A
mec ha nis m of acti o n
M QI
me dicall y  q ualifie d i n di vi d ual
M RI
ma g netic res o na nce i ma gi n g
M T D
ma xi m u m t olerate d d ose
m T PI
m o difie d t o xicit y  pr o ba bilit y i nter val
M U G A
m ulti gate d ac q uisiti o n sca n
N, n
n u m ber
N A
n ot a p plica ble
N A b
ne utralizi n g a nti b o dies
N B F
ne utral -b uffere d f or mali n
N CI
Nati o nal Ca ncer I nstit ute
N H L
n o n -H o d g ki n L y m p h o ma
NI M P
n o n -i n vesti gati o nal me dici nal pr o d uct
N K
nat ural killer
N O S
n ot ot her wise s pecifie d
O R
o bjecti ve res p o nse
O R R
o bjecti ve res p o nse rate
O S
o verall s ur vi val
P A C L
Pr ot oc ol A d mi nistrati ve C ha n ge Letter
P D
p har mac o d y n a mics(s), pr o gressi ve disease
P E
p h y sical e xa mi nati o n
P E T
p ositr o n e missi o n t o m o gra p h y
P F S
pr o gressi o n -free s ur vi val
PI
Pri nci pal I n vesti gat or
P K
p har mac o ki netic(s)
P O
b y m o ut h
P R
partial res p o nse/ p ulse rate
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 7
A b bre vi ati o n
Ter m
P P D
pr o d uct of t he per pe n dic ular dia meters
P P P
pre g na nc y  pre ve nti o n pla n
R P 2 D
rec o m me n de d P hase 2 d ose
R P 3 D
rec o m me n de d P hase 3 d ose
P S S A
Pfizer's Seri o us A d verse E ve nt S u b missi o n Assista nt
p T
tar get pr o ba bility
P T
pr ot hr o m bi n ti me
P T C L
peri p heral T -cell l ym p h o ma
P T T
partial t hr o m b o plasti n ti me
P V C
pre mat ure ve ntric ular c o ntracti o n
Q 2 W
o nce e ver y  t w o wee ks
Q 1 2 W
o nce e ver y  1 2 wee ks
Q D
o nce dail y 
Q Tc
c orrecte d Q T i nter val
Q Tc F
Q Tc ( Fri dericia met h o d)
Q T L
q ualit y  t olera nce li mit
Q W
o nce wee kl y
R -C H O P
rit u xi ma b, c ycl o p h os p ha mi de, d o x or u bici n, vi ncristi ne, pre d nis ol o ne
R -C H P
rit u xi ma b, c ycl o p h os p ha mi de, d o x or u bici n, pre d nis ol o ne
R B C
re d bl o o d cell
R -D H A P
rit u xi ma b, de xa met has o ne, c ytara bi ne, cis plati n
R E M S 
Ris k E val uati o n a n d Miti gati o n Strate g y
R -Ge m O x
rit u xi ma b, ge mcita bi ne a n d o xali plati n
R -I CE
rit u xi ma b, if osfa mi de, car b o plati n, et o p osi de
R N A
ri b o n ucleic aci d
R/ R
rela pse d/refract or y
S A E
seri o us a d verse e ve nt
S A P
Statistical A nal y sis Pla n
S A R S -C o V -2
se vere ac ute res pirat or y s yn dr o me c or o na vir us 2
Scr
ser u m creati ni ne
Sc y s
ser u m c ystati n C
S D
sta ble disease, sta n dar d de viati o n
S Di
s h ort dia meter
SJ S
Ste ve ns -J o h ns o n s yn dr o me
S m P C
S u m mar y  of Pr o d uct C haracteristics
SI R P
si g nal re g ulat or y pr otei n
S o A
sc he d ule of acti vities
S O P
sta n dar d o perati n g pr oce d ure
S P D
s u m of t he pr o d uct of t he dia meters
S R S D
Si n gle refere nce Safet y D oc u me nt
S SI D
si n gle s u bject i de ntifier
S U S A R
S us pecte d U ne x pecte d Seri o us A d verse Reacti o n
t½
ter mi nal eli mi nati o n half-life
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 8
A b bre vi ati o n
Ter m
S U V ma x
ma xi m u m sta n dar d u nit val ue
T bili
t otal bilir u bi n
T E A E
treat me nt-e mer ge nt a d verse e ve nt 
T E N
t o xic e pi der mal necr olys is
T L S
t u m or l ysis s yn dr o me
T ma x
ti me t o ma xi m u m c o nce ntrati o n
T o C
ta ble of c o nte nt
T X
treat me nt
U L N
u p per li mit of n or mal
U P M
u nit pr o ba bilit y  mass
U S
U nite d States
U S PI
U nite d State Prescri bi n g I nf or mati o n
U V B
ultra vi olet B
V T E
ve n o us t hr o m b oe m b olis m
W B C
w hite bl o o d cell
W H O
W orl d Healt h Or ga nizati o n
W O C B P
w o ma n/ w o me n of c hil d beari n g p ote ntial
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)
C CI

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 9
1 1. R E F E R E N C E S
1
S usa ni bar -A da ni ya  S, Barta S K. 2 0 2 1 U p date o n Diff use lar ge B cell ly m p h o ma: A 
re vie w of c urre nt data a n d p ote ntial a p plicati o ns o n ris k stratificati o n a n d ma na ge me nt. 
A m J He mat ol. 2 0 2 1; 9 6( 5): 6 1 7 - 2 9.
2
Pe y ra de F, Jar di n F, Gissel brec ht C, et al. Rit u xi ma b a n d Re d uce d D ose C H O P ( R -mi ni -
C H O P) f or Patie nts O ver 8 0 Years wit h Diff use Lar ge B- Cell L y m p h o ma ( D L B C L) –
Gr o u pe d' Et u de Des L y m p h o mes De l' A d ulte ( G E L A) St u d y  LN H 0 3 -7 B. Bl o o d. 
2 0 1 0; 1 1 6( 2 1): A bstract 8 5 3.
3
Se h n L a urie H., Hertz ber g Mar k, O pat Ste p he n, et al. P olat uz u ma b Ve d oti n Pl us 
Be n da m usti ne a n d Rit u xi ma b i n Rela pse d/ Refract or y  Diff use Lar ge B-Cell L y m p h o ma: 
U p date d Res ults of a P hase I b/II Ra n d o mize d St u d y  a n d Preli mi nar y Res ults of a 
Si n gle -Ar m E xte nsi o n. Bl o o d. 2 0 2 0; 1 3 6 S u p pl 1: 1 7 - 1 9.
4
Se h n L a urie H., Herrera Ale x F., Fl o wers C hrist o p her R., et al. P olat uz u ma b Ve d oti n i n 
Rela pse d or Refract or y  Diff use Lar ge B-Cell L y m p h o ma. J Cli n O nc ol. 2 0 2 0 ;
3 8( 2): 1 5 5 - 1 6 5.
5
Till y  H, M orsch ha user F, Se h n L H, et al. P olat uz u ma b Ve d oti n i n Pre vi o usl y  U ntreate d 
Diff use Lar ge B- Cell L y m p h o ma. N E n gl J Me d. 2 0 2 2; 3 8 6( 4): 3 5 1 - 6 3.
6
Salles G, D uell J, G o nzalez Barca E, et al. Tafasita ma b pl us le nali d o mi de i n rela pse d or 
refract or y diff use lar ge B-cell l ym p h o ma ( L -MI N D): a m ultice ntre, pr os pecti ve, si n gle -
ar m, p hase 2 st u d y. La ncet O nc ol. 2 0 2 0; 2 1( 7): 9 7 8 - 8 8.
7
H o y  S M. Tafasita ma b: First A p pr o val. Dr u gs. 2 0 2 0; 8 0( 1 6): 1 7 3 1- 3 7.
8
L oc ke, G h o ba di, Jac o bs o n, et al. L o n g -ter m safety a n d acti vit y of a xica bta ge ne 
cil ole ucel i n refract or y lar ge B-cell l y m p h o ma ( Z U M A - 1): a si n gle-ar m, m ultice ntre, 
p hase 1 – 2 trial. La ncet O nc ol o g y , 2 0 1 9; 2 0 1: 3 1-4 2.
9
Pac ka ge I nsert - Y E S C A R T A (f da. g o v) .
1 0
Patel, Z o n der, Sa n o, et al. C D 4 7 -Bl oc ker T TI -6 2 2 S h o ws Si n gle -A ge nt Acti vit y  i n 
Patie nts wit h A d va nce d Rela pse d or Refract or y  Ly m p h o ma: U p date fr o m t he O n g oi n g 
First -i n-H u ma n D ose Escalati o n St u d y . Bl o o d. 2 0 2 1; 1 3 8: 3 5 6 0.
1 1
Ma n gel ber ger D, A u gs ber ger C, La n d graf K, et al. Bl oc ka de of t he C D 4 7/ SI R P α 
C hec k p oi nt P ote ntiates t h e A nti-T u m or Efficac y  of Tafasita ma b. Bl o o d. 2 0 2 0; 1 3 6: 1 1-
1 2.
                                                
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 7 0
1 2
H ort o n H M, Ber nett MJ, P o n g E, et al. P ote nt i n vitr o a n d i n vi v o acti vit y  of a n Fc-
e n gi neere d a nti -C D 1 9 m o n ocl o nal a nti b o d y  a gai nst l ym p h o ma a n d le u ke mia. Ca ncer 
Res. 2 0 0 8; 6 8( 1 9): 8 0 4 9 -5 7.
1 3
Ga rciaz S, C os o D, Sc hia n o de C olella J M, et al. Le nali d o mi de f or t he treat me nt of B -
cell l ym p h o ma. E x pert O pi n I n vesti g Dr u gs. 2 0 1 6; 2 5( 9): 1 1 0 3 - 1 6.
1 4
C hes o n Br uce D., N o wa k o ws ki Grze g orz, Salles Gilles. Diff use lar ge B -cell l ym p h o ma: 
ne w tar gets a n d n o vel t h era pies. Bl o o d Ca ncer J o ur nal. 2 0 2 1; 1 1: 6 8
1 5
C ha o M P, Aliza de h A A, Ta n g C, et al. T hera pe utic a nti b o d y tar geti n g of C D 4 7 
eli mi nates h u ma n ac ute l ym p h o blastic le u ke mia. Ca ncer Res. 2 0 1 1; 7 1( 4): 1 3 7 4 - 8 4.
1 6
C ha o M P, Aliza de h A A, Ta n g C, et al. A nti- C D 4 7 a nti b o d y s yner gizes wit h rit u xi ma b 
t o pr o m ote p ha g oc yt osis a n d era dicate n o n-H o d g ki n l y m p h o ma. Cell. 2 0 1 0; 1 4 2( 5): 6 9 9 -
7 1 3.
1 7
Jais wal S, Ja mies o n C H, Pa n g W W, et al. C D 4 7 is u pre g ulate d o n circ ulati n g 
he mat o p oietic ste m cells a n d le u ke mia cells t o a v oi d p ha g oc y t osis. Cell. 
2 0 0 9; 1 3 8( 2): 2 7 1 - 8 5.
1 8
Majeti R, C ha o M P, Aliza de h A A, et al. C D 4 7 is a n a d verse pr o g n ostic fact or a n d 
t hera pe utic a nti b o d y tar get o n h u ma n ac ute myel oi d le u ke mia ste m cells. Cell. 
2 0 0 9; 1 3 8( 2): 2 8 6 - 9 9.
1 9
Petr o va P S, Viller N N, W o n g M, et al. T TI- 6 2 1 ( SIR Pal p ha Fc): A C D 4 7- Bl oc ki n g 
I n nate I m m u ne C hec k p oi nt In hi bit or wit h Br oa d A ntit u m or Acti vit y  a n d Mi ni mal 
Er y t hr oc yte Bi n di n g. Cli n Ca ncer Res. 2 0 1 7; 2 3( 4): 1 0 6 8- 7 9.
2 0
Re vli mi d, I N N -le nali d o mi de (e ur o pa.e u).
2 1
C he n N, Z h o u S, Pal misa n o M. Cli nical P har mac o ki netics a n d P har mac o d y na mics of 
Le nali d o mi de. Cli n P har mac o ki net. 2 0 1 7; 5 6( 2): 1 3 9- 5 2.
2 2
MI NJ U VI, I N N -tafasita ma b (e ur o pa.e u).
2 3
Ga n garaj u Ra d hi ka, B hatia S mita, Ke nzi k Kell y . Ve n o us-T hr o m b oe m b olis m i n El derl y  
Patie nts wit h Diff use Lar ge B Cell L y m p h o ma. Bl o o d. 2 0 2 0; 1 3 6 S u p pl 1: 4 - 4
2 4
Bast uji -Gari n S, Rza n y  B, Ster n R S, et al. Cli nical classificati o n of cases of t o xic 
e pi der mal necr ol ys is, Ste ve ns-J o h ns o n s yn dr o me, a n d er y t hr o der ma m ultif or me. Arc h 
Der mat ol. 1 9 9 3; 1 2 9: 9 2 -9 6.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 7 1
2 5
C h o u d har y  S o nal, Mc Le o d Mic hael, T orc hia Da niele, et al. Dr u g Reacti o n wit h 
E osi n o p hilia a n d S y ste mic S ym pt o ms ( D R E S S) S y n dr o me. J o ur nal of Cli nical a n d 
Aest hetic Der mat ol o g y . 2 0 1 3; 6(6): 3 1 - 7
2 6
H o war d S C, J o nes D P, P ui C H. T he t u m or l y sis s yn dr o me. N E n gl J Me d. 
2 0 1 1; 3 6 4( 1 9): 1 8 4 4 - 5 4.
2 7
C he s o n B D, Fis her RI, Barri n gt o n S F, et al. Rec o m me n dati o ns f or i nitial e val uati o n, 
sta gi n g, a n d res p o nse assess me nt of H o d g ki n a n d n o n-H o d g ki n l y m p h o ma: t he L u ga n o 
classificati o n. J Cli n O nc ol. 2 0 1 4; 3 2( 2 7): 3 0 5 9- 6 8.
2 8
Lee MJ, K off J L,  S witc he n k o J M, et al. Gen o me -defi ne d Africa n a ncestr y  is ass ociate d 
wit h disti nct m utati o ns a n d w orse s ur vi val i n patie nts wit h diff use lar ge B -cell 
l ym p h o ma. Ca ncer. 2 0 2 0; 1 2 6( 1 5): 3 4 9 3 - 5 0 3.
2 9
Ala g gi o R, A ma d or A, A na g n ost o p o ul os et al. T he 5t h e diti o n of t he W orl d Healt h 
Or ga niza ti o n Classificati o n of Hae mat oly m p h oi d T u m o urs: L y m p h oi d Ne o plas ms. 
Le u ke mia 2 0 2 2; 3 6( 7): 1 7 2 0- 4 8
3 0
I nter pretati o n of He patitis B Ser ol o gic Test Res ults. De part me nt of Healt h & H u ma n 
Ser vices, Ce nters f or Disease C o ntr ol a n d Pre ve nti o n. A vaila ble fr o m: 
C D C _ He patitis B _ Ser ol o gic Test _ Fact S heet 9.i n d d. Accesse d o n: 2 3 Mar 2 0 2 2.
3 1
I nter pretati o n of Res ults of Tests f or He patitis C Vir us ( H C V) I nfecti o n a n d F urt her 
Acti o ns. De part me nt of Healt h & H u ma n Ser vices, Ce nters f or Disease C o ntr ol a n d 
Pre ve nti o n. A vail a ble fr o m: hc v _ gra p h. p df (c dc. g o v). Accesse d o n: 2 3 Mar 2 0 2 2.
3 2
Neela p u S S, T u m mala S, Ke briaei P, et al. C hi meric a nti ge n rece pt or T -cell t hera p y -
assess me nt a n d ma na ge me nt of t o xicities. Nat Re v Cli n O nc ol. 2 0 1 8; 1 5( 1): 4 7 - 6 2.
3 3
Neela p u S S. Ma na gi n g t he t o xicities of C A R T ‐cell t hera py. He mat ol o gical o nc ol o g y. 
2 0 1 9; 3 7: 4 8 - 5 2.
3 4
I n ker L A et al. Ne w creati ni ne- a n d c ystati n C-base d e q uati o ns t o esti mate G F R wit h o ut 
race. N E n gl J Me d. 2 0 2 1; 3 8 5: 1 7 3 7- 4 9.
3 5
C hes o n B D et al. Refi ne me nt of t he L u ga n o Classificati o n l y m p h o ma res p o nse criteria 
i n t he era of i m m u n o m o d ulat or y t hera p y. Bl o o d. 2 0 1 6; 1 2 8( 2 1): 2 4 8 9- 2 4 9 6.
3 6
Ricar d F, C hes o n B, Barri n gt o n S et al. A p plicati o n t he L u ga n o Classificati o n f or I nitial 
E val uati o n, Sta gi n g, a n d Res p o nse Assess me nt of H o d g ki n a n d N o n -H o d g ki n 
L y m p h o ma: T he P R o L o G C o nse ns us I nitiati ve ( Part 1 - Cli nical). J N ucl Me d. 2 0 2 3; 
6 4: 1 0 2 - 0 8
3 7
Ricar d F, Barri n gt o n S, K or n R et al. A p plicati o n of t he L u ga n o Classificati o n f or I nitial  
E val uati o n, Sta gi n g, a n d Res p o nse Assess me nt of H o d g ki n a n d N o n -H o d g ki n 
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)

P F -0 7 9 0 1 8 0 1
Pr ot oc ol C 4 9 7 1 0 0 3
Pr ot oc ol A me n d me nt 2 , 0 9 Dec 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 7 2
L y m p h o ma: T he P R o L o G C o nse ns us I nitiati ve ( Part 2 - Tec h nical). J N ucl Me d. 
2 0 2 3; 6 2 - 2 3 9- 4 3.
3 8
O ke n M M, Creec h R H, T or me y  D C, et al. T o xicit y a n d res p o nse criteria of t he Easter n 
C o o perati ve O nc ol o g y  Gr o u p. A m J Cli n O nc ol; 1 9 8 2; 5( 6)( Dec): 6 4 9- 5 5.
0 9 0 1 7 7 e 1 a 2 5 8 b 7 2 1\ A p pr o v e d\ A p pr o v e d O n: 1 3- D e c- 2 0 2 4 0 5: 5 7 ( G M T)