Clinical trial: NCT02658097
Section: Alternatives
Subsections: W H At Are M Y Ot Her C H Oices If I D O N Ot T A Ke P Art I N T His St U D Y ?

If y o u deci d e n ot t o ta ke part i n t his st u d y, y o u ha ve ot her c h oices. F or e xa m ple:  
- Y o u ma y c h o ose t o ha v e t he us ual a p pr oac h descri be d a b o ve  
- Y o u ma y c h o ose t o ta ke part i n a differe nt st u d y, if o ne is a vaila ble  
- Or, y o u ma y c h o ose n ot t o be treate d f or ca ncer . F or e xa m ple: c o mf ort/ palliati ve car e
Clinical trial: NCT02658097
Section: Confidentiality
Subsections: H O W Will T He C O Nfi De Nti Alit Y O F M Y T U M Or S A M Ples Be Pr Otecte D ?|Hipaa Authorization Authorization To Use Or Disclose (Release) Health Information That Identifies You For A Research Study

T he st u d y d o ct or, st u d y staff, a n d S p o ns or will ma ke reas o n a ble eff orts t o kee p a n d mai ntai n t he c o nfi de ntialit y of y o ur pers o nal healt h i nf or mati o n a n d t he st u d y rec or ds rel ati n g t o y o ur sa m ples, as well as y o ur s a m ples t he msel ves. H o w e ver, y o ur st u d y d oct or a n d researc hers ca n n ot g uar a ntee a bs ol ute c o nfi de ntialit y of t he sa m ples t h at y o u pr o vi de f or t h e res ear c h d escri be d i n t his c o ns e nt f or m. T he s a m ples c ollecte d b y y o ur st u d y d oct or a n d se nt t o t he c olla b orat ors or part ners will n ot be la bel e d t o i d e nt if y y o u b y na m e, y o ur h os pital/cli nical me dical rec or d n u m ber, a d dress or a n y c o ntact i nf or mati o n. T h e sa m ples pr o vi de d t o t he r esear c hers, or its part ners, will o nl y be la bele d wit h a s u bject i de ntificati o n n u m ber. O nl y t he st u d y d oct ors will kee p a c o de ke y t hat ma kes it p ossi ble t o li n k y o ur st u d y n u m ber t o y o ur na me a n d c o ntact i nf or mati o n. T he c o m plete a nal ysis a n d a n y resear c h fi n di n gs deri ve d fr o m t he st u dies will be c o nsi dere d  
"c o m plete r esearc h dat a." C o m plete researc h data will n ot be gi ve n t o y o u or y o ur fa mil y me m bers .  
T he c o m plete researc h d ata bel o n gs t o t he st u d y resear c h tea m a n d ma y be use d f or a n y p ur p ose.  
F or e xa m ple, s o me of t he wa ys t he st u d y researc h ers ma y use a n d s hare t he researc h data i ncl u de f or p u blicati o n, f urt her researc h, vali dati o n, q ualit y c o ntr ol, c o m mercial a p plicati o ns, a n d all ot her reas o na bl e p ur p os es. T h e r esearc hers will use reas o na ble eff orts t o pr ot ect t he c o nfi de ntialit y of y o ur sa m ples a n d t he d at a ac q uir e d fr o m a nal yzi n g y o ur sa m ples. A n y r e p orti n g of y o ur res ear c h data will n ot us e a n y i n di vi d ual i de ntificati o n, a n d t he use a n d trac ki n g of y o ur sa m ples is descr i be d b el o w.  
F or m ore i nf or mati o n please refer t o t he secti o n o n ge netic testi n g o n pa ges 9- 1 0, a n d/ or as k y o ur d oct or.

If you volunteer to participate in this research, your protected health information (PHI) that identifies you will be used or disclosed to: Dr. Nathan Pennell and the research study staff at Cleveland Clinic for the purposes of this research and to Case Western Reserve University for administration.  
The PHI that we may use or disclose (release) for this research may include your name, address, phone number, date of birth, Social Security number, information from your medical record, lab tests, or certain information relating to your health or condition. Some of the tests and procedures done solely for this research study may also be placed in your medical record so other doctors know you are in this study. Upon completion of the study, you may have access to the research information that is contained in your medical record.  
In addition to the investigators and research staff listed above, your PHI may be looked at by other groups involved with the study such as the Cleveland Clinic Institutional Review Board, and the Case Comprehensive Cancer Center Protocol Review and Monitoring Committee. Your PHI may also be used by and/or disclosed (released) to:
.  
.  
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The Cleveland Clinic, its monitors and representatives Merck Pharmaceutical, its study monitors and representatives Merck Pharmaceutical collaborators and licensees (people and companies who partner with Merck)
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Case Comprehensive Cancer Center members and collaborators The Food and Drug Administration; The Department of Health and Human Services;
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The National Cancer Institute (NCI);
Other Institutional Review Boards; Data Safety and Monitoring Boards;
Once your personal health information is released it may be re-disclosed and no longer protected by privacy laws.  
Your research information may be used and disclosed indefinitely, but you may stop these uses and disclosures at any time by writing to:
Nathan Pennell, MD, PhD  
  
Case Comprehensive Cancer Center  
  
Cleveland Clinic Taussig Cancer Institute,  
  
Your participation in the research will stop, but any information previously recorded about you cannot be removed from the records and will continue to be used as part of this research. Information already disclosed outside the Cleveland Clinic cannot be retrieved. This will not affect your rights to treatment or benefits outside the research study.  
The Cleveland Clinic will not use your information collected in this study for another research purpose without your written permission; unless the Cleveland Clinic Institutional Review Board
(IRB) assures your privacy and confidentiality is protected. The IRB is a committee whose job it is to protect the safety and welfare of research subjects.  
By signing this informed consent form, you are authorizing such access to your research and medical record information. If you choose not to sign this consent form, you will not be able to participate in this research study. This Authorization does not have an expiration date.
Clinical trial: NCT02658097
Section: Duration of Study Involvement
Subsections: H O W L O N G Will I Be I N T His St U D Y ?|C O R E S T U D Y P E Ri O D ( T R E A T M E N T)|O B S E R V A Ti O N P H A S E ( P O S T S T U D Y)

T his st u d y is bei n g c o n d ucte d at 9 f acilities: Cle vela n d Cli nic's Mai n h os pital a n d its re gi o n al facilities, Alle g ha n y Me m orial, R os well Par k, R us h U ni versit y , a n d N Y U La n g o ne .  
A p pr o xi matel y 4 8 s u bjects will be e nr olle d i n t his trial o verall. Y o u ca n be o n t he core part of t his treat me nt f or u p t o 2 8 wee ks. After t hat, y o u will c o nti n ue o n pe m br oliz u ma b sta n dar d of care a n d f oll o we d u ntil y o ur disease has pr o gr esse d.

If fr o m t he s cree ni n g it is deter mi ne d y o u are eli gi ble t o partici pate i n t h e st u d y y o u will be gi n treat me nt. T he c or e st u d y peri o d will start wit h t he si n gle d ose of ra diati o n a n d t he n y o u will c o nti n ue f or t he first ei g ht treat me nts of pe m br oliz u ma b; t hat is 2 4-2 8 wee ks . Y o ur disease will c o nti n ue t o be meas ur e d b y C T or M RI sca ns as i n dicate d .  
Y o u will als o ha ve:  
- Vital Si g ns ta ke n  
- Wei g ht Meas ur e d  
- Safet y La b or at or y Bl o o d tests  
- Re vie w of s y m pt o ms a n d si de effects  
- Directe d P h ysical E x a m as i n dicate d b y t he r esear c h staff .  
- I n cl u de - E xtra bl o o d f or E x pl orat or y Bi o mar ker Assess me nt at e ver y c y cle d uri n g t he treat me nt p eri o d, wit h t he e xce pti o n of c ycle 1, a n d c ollecti o n at t he e n d of treat me nt visit .  
T he pe m br oliz u ma b will c o nti n ue f or u p t o 8 c ycles u nless a n y of t he f oll o wi n g reas o ns ca use y o ur treat me nt t o st o p bef or e t he 8 c ycles:  
- Y o ur disease h as pr o gr esse d  
- T here h as bee n a seri o us a d vers e e v e nt or me dical e mer ge nc y t hat pr e v e nts y o u fr o m c o nti n ui n g treat me nt  
- Y o u wit h dra w or n o l o n g er wis h t o partici pate i n t he st u d y  
- Fail ure or i na bilit y t o f ulfill trial re q uire me nts  
- Y o ur d oct or f eels it is n o l o n ger i n y o ur best i nterest t o re mai n o n treat me nt Y o u will als o be re q uire d t o ha ve a ne w bi o ps y aft er t w o treat me nts of y o ur st u d y dr u g, u nless wai ve d b y t he s p o ns or.  
F oll o wi n g t he 8 c ycles, if t he ca ncer is res p o n di n g t o treat me nt, y o ur p h ysicia n will c o nti n ue treat me nt wit h pe m br oliz u ma b as a sta n dar d tr eat me nt ( Pe m br oliz u ma b is alrea d y F D A a p pr o ve d treat me nt f or l u n g ca ncer).

F oll o wi n g t he 8 c ycl es of st u d y peri o d or treat me nt, y o u will be e nteri n g t he o bser v ati o n part of t he st u d y. I n t he o bser vati o n part of t he st u d y, if y o ur p h ysicia n deter mi nes y o ur ca ncer is c o nti n ui n g t o res p o n d t o pe m br oliz u ma b, y o u will be c o nti n ui n g t he treat me nt wit h pe m br oliz u ma b. T he i n v esti gat ors will be c ollecti n g i nf or mati o n re gar di n g y o ur o utc o me a n d f ut ure treat me nt f or y o ur ca ncer y o u ma y b e recei vi n g. Y o ur st u d y d oct or will pr o vi de t he bl o o d sa m ples a n d t h e ca ncer tiss ue t o c olla b orat ors f or resear c h. T h e c olla b orat ors will c o n d uct researc h o n y o ur bl o o d a n d ca n cer tiss ue sa m ples.  
Y o ur bl o o d a n d tiss ue sa m ples, as well as t he researc h dat a o btai ne d fr o m t he a nal yses of y o ur sa m ples, will be ke pt f or a n i n defi nite ti me a n d ma y b e use d i n p ote nti al u ns pecifi e d f ut ure researc h. Alt h o u g h t he researc hers or t he part n ers ma y st ore a n d mai ntai n y o ur sa m ples f or p ossi ble use, t he y d o n ot pr o mise t o kee p or st ore t he m at all. I n a d diti o n, e ve n if t he res ear c hers or t he part ners d o st ore y o ur sa m ples, t here is n o g uara ntee t hat t he sa m ples will n ot r u n o ut, be l ost or be da ma ge d.  
O nce y o u c o m plete t he 8 c ycles of st u d y peri o d or treat me nt e n ds f or a n y of t he a b o ve reas o ns, y o u will be i n w hat is call e d f oll o w -u p. D uri n g f oll o w -u p peri o d, y o u will b e as ke d t o ret ur n t o t he cli nic a p pr o xi matel y 3 0 da ys after y o u st o p ta ki n g t he st u d y dr u g or b ef ore y o u start a n e w treat me nt f or y o ur ca ncer, w hic he v er c o mes first. If d uri n g f oll o w-u p peri o d, y o ur ca n cer gets w orse or y o u start a ne w treat me nt f or y o ur ca n cer, y o u ma y be c o nt acte d f or s ur vi val f oll o w - u p b y tele p h o ne a b o ut e v er y 1 2 wee ks.
Clinical trial: NCT02658097
Section: Participant's Rights
Subsections: W H At Are M Y Ri G Hts I N T His St U D Y ?

Ta ki n g part i n t his st u d y is y o ur c h oice. N o matt er w hat decisi o n y o u ma ke, a n d e v e n if y o ur decisi o n c ha n g es, t here will be n o pe n alt y t o y o u. Y o u will n ot l ose me dical care or a n y le g al ri g hts.  
W h at Are T he C osts Of T a ki n g P art I n T his St u d y ?  
Y o ur i n v ol ve me nt i n t his researc h st u d y is v ol u ntar y a n d y o u will n ot be pai d f or y o ur partici pati o n.  
T he st u d y a g e nt, pe m br oliz u ma b , will be pr o vi d e d free of c har ge b y Mer c k , o ver t h e 8 tr eat me nt i nf usi o ns w hile y o u are o n st u d y treat me nt. Neit her y o u n or y o ur i ns ura nce pr o vi der will be res p o nsi ble f or t he c osts of a n y resear c h-o nl y tests or pr oce d ures. T he bl o o d w or k f or researc h p ur p oses will n ot be c har ge d t o y o u. It will be pai d f or b y t he res ear c h st u d y.  
Y o u a n d/ or y o ur h ealt h pla n/i ns ura nce c o m pa n y will nee d t o pa y f or s o me or all of t h e c osts of treati n g y o ur ca n cer i n t his st u d y (i.e., ra di ati o n t hera p y, m e dical hist or y, r e vie w of me dicati o ns, p h ysical e xa ms, perf or m a nce stat us, r o uti ne bl o o d tests, pre g na nc y test, x -ra ys a n d/ or s ca ns f or t u m or meas ure me nt). S o me healt h pla ns will n ot pa y t hese c osts f or pe o ple ta ki n g part i n st u dies.  
C hec k wit h y o ur healt h pla n or i ns ura nce c o m pa n y t o fi n d o ut w hat t he y will pa y f or. Ta ki n g part i n t his st u d y ma y or ma y n ot c ost y o ur i ns ura nce c o m pa n y m ore t ha n t he c ost of getti n g re g ular ca ncer treat me nt.  
F or m ore i nf or mati o n o n cli nical trials a n d i ns ura n ce c o v era g e, y o u ca n visit t he Nati o nal Ca ncer I nstit ute's We b site at htt p:// w w w.ca ncer. g o v/cli nicaltrials/lear ni n ga b o ut .
Clinical trial: NCT02658097
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: W H At P Ossi Ble Ris Ks C A N I E X Pect F R O M T A Ki N G P Art I N T His St U D Y ?|P Ossi Ble Si De Effects Of P E M Br Oliz U M A B ( K E Y T R U D A):|U N C O M M O N, S O M E M A Y B E S E Ri O U S (I.E. C A Usi N G, H Os Pit Aliz Ati O N, Life T Hre Ate Ni N G, Or|R A R E, S O M E M A Y B E S E Ri O U S (I.E. C A Usi N G H Os Pit Aliz Ati O N, Life -T Hre Ate Ni N G, Or W Here N Ote D, M A Y C A Use De At H)|Re Pr O D Ucti Ve Ris Ks|P Ote Nti Al Ris K Or Disc O Mf Ort Fr O M Rese A Rc H P R Oce D Ures Bl O O D Dra Ws|W H At P Ossi Ble Be Nefits C A N I E X Pect Fr O M T A Ki N G P Art I N T His St U D Y ?|W H At H A P Pe Ns If I A M I Nj Ure D Or H Urt Bec A Use I T O O K P Art I N T His St U D Y ?

If y o u c h o ose t o ta k e part i n t his st u d y, t here is a ris k t hat:  
- Y o u ma y l ose ti me at w or k or h o me a n d s pe n d m ore ti me i n t he h os pital or d oct or's o ffice t ha n us ual  
- Y o u ma y be as k e d se nsiti ve or pri vate q u esti o ns w hic h y o u n or mall y d o n ot disc uss  
- T here is a ris k s o me o ne c o ul d get access t o t h e pers o nal i nf or mati o n i n y o ur me dical rec or ds or ot her i nf or mati o n researc hers ha v e ke pt a b o ut y o u. S o me o ne mi g ht be a ble t o trace t his i nf or mati o n bac k t o y o u. T he res ear c hers belie ve t h e c h a nce t hat s o me o ne will i de ntif y y o u is ver y s mall, b ut t he ris k ma y c ha n g e i n t he f ut ure as pe o ple c o me u p wit h ne w wa ys of tr aci n g i nf or mati o n. I n s o me cases, t his i nf or mati o n c o ul d be use d t o ma ke it har der f or y o u t o get or kee p a j o b. T here are la ws a gai nst mis use of ge netic i nf or mati o n, b ut t he y ma y n ot gi ve f ull pr otecti o n. T he resear c hers belie ve t he c ha n ce t hese t hi n gs will ha p pe n is ver y s mall, b ut ca n n ot pr o mise t hat t he y will n ot occ ur.  
- T here ca n als o b e a ris k i n fi n di n g o ut ne w ge n etic i nf or mati o n a b o ut y o u. Ne w healt h i nf or mati o n a b o ut i n herite d traits t hat mi g ht affect y o u or y o ur bl o o d relati ves c o ul d be f o u n d d uri n g a st u d y.  
T he dr u gs use d i n t his st u d y ma y affect h o w differe nt parts of y o ur b o d y w or k s uc h as y o ur li ver, ki d ne ys, heart, a n d bl o o d. T he st u d y d oct or will be testi n g y o ur bl o o d a n d will let y o u k n o w if c ha n ges occ ur t hat ma y affect y o ur h ealt h.  
T here is als o a ris k t hat y o u c o ul d ha ve si de effects fr o m t he st u d y dr u g(s)/st u d y a p pr oac h.  
Here are i m p orta nt p oi nts a b o ut si de eff ects:  
T he st u d y d oct ors d o n ot k n o w w h o will or will n ot ha ve si de effects.  
- S o me si de eff ects ma y g o a wa y s o o n, s o me ma y last a l o n g ti me, or s o me ma y ne ver g o a wa y.  
- S o me si de effects ma y i nterfer e wit h y o ur a bilit y t o ha ve c hil dre n.  
- S o me si de effects ma y be seri o us a n d ma y e v e n res ult i n deat h.  
Here are i m p orta nt p oi nts a b o ut h o w y o u a n d t he st u d y d oct or ca n ma ke si de effects less of a pr o ble m:  
- Tell t he st u d y d oct or if y o u n otice or feel a n yt hi n g differ e nt s o t he y ca n see if y o u are ha vi n g a si de effect.  
- T he st u d y d oct or ma y be a ble t o treat s o me si de effects.  
- T he st u d y d oct or ma y a dj ust t he st u d y dr u gs t o tr y t o re d uce si de eff ects.  
T he ta bles b el o w s h o w t he m ost c o m m o n a n d t he m ost seri o us si de eff ects t hat res ear c hers k n o w a b o ut. T here mi g ht be ot her si de effects t hat res earc hers d o n ot yet k n o w a b o ut. If i m p orta nt ne w si de effects ar e f o u n d, t h e st u d y d oct or will disc uss t hese wit h y o u.  
If y o u e x perie nce se v ere si de effects ass o ciate d wit h t he st u d y dr u g, y o ur d oct or ma y prescri be me dicati o ns t o treat t he si de eff ect(s), f ut ure treat me nts ma y be dela y e d, or treat me nt m a y be st o p pe d per ma ne ntl y. A n y si g nifica nt ne w fi n di n gs t hat de vel o p d uri n g t he c o urse of t h e res ear c h a n d ma y relat e t o y o ur willi n g ness t o c o nti n ue partici pati o n will be pr o vi de d t o y o u.  
T hese si de eff ects ma y b e seri o us (i.e. ca usi n g h os pitalizati o n or be life-t hreate ni n g), ma y r es ult i n deat h, a n d/ or ma y occ ur after y o u st o p ta ki n g p e m br oliz u ma b .

V E R Y C O M M O N, S O M E M A Y B E S E RI O U S (i.e. c a usi n g h os pit aliz ati o n, life -t hre at e ni n g or w here n ot e d, m a y c a use de at h)  
O ut of 1 0 0 pe o ple w h o r ecei ve p e m br oliz u ma b, 2 0 or m ore pe o ple m a y ha ve t he f oll o wi n g:  
- Itc hi n g of t he s ki n  
- C o u g h  
- L o ose or Wat er y St o ols C O M M O N, S O M E M A Y B E S E RI O U S (i.e. c a usi n g h os pit aliz ati o n, life-t hre ate ni n g, or w here n ote d, m a y c a use de at h)  
O ut of 1 0 0 p e o ple w h o r ecei ve pe m br oliz u ma b, at least 5 b ut less t ha n 2 0 pe o ple ma y ha ve t he f oll o wi n g:  
- J oi nt pai n - Fe ver  
- Bac k Pai n  
- Ras h  
- Pai n i n y o ur bell y  
- L oss of s ki n c ol or  
- N ot e n o u g h t h yr oi d h or m o ne s o y o u ma y f eel tire d, gai n wei g ht feel c ol d, h a ve i nfr e q ue nt or har d st o ols  
- L o w le vels of salt i n t he bl o o d t hat ma y ca use y o u t o feel tir e d c o nf use d, h a ve a h ea dac he, m uscle cra m ps, a n d/ or feel sic k t o y o ur st o mac h

w here n ote d m a y c a use de at h)  
O ut of 1 0 0 pe o pl e w h o recei v e pe m br oliz u ma b, at least 1 b ut less t h a n 5 pe o ple ma y h a ve t h e f oll o wi n g:  
- T o o m uc h t h yr oi d h or m o ne s o y o u ma y feel a n xi o us, a n gr y, ha ve tr o u bl e slee pi n g, feel wea k, tre m ble, s weat, f eel tire d, ha ve l o ose a n d water y st o ols  
- I nfla m mati o n of t he l u n gs s o y o u ma y f eel s h ort of breat h a n d c o u g h. S o meti mes t his mi g ht lea d t o deat h  
- I nfla m mati o n of t he b o wels/ g ut t hat ma y ca use pai n i n y o ur bell y wit h l o ose or water y st o ols, a n d blac k, tarr y, stic k y st o ols or st o ols wit h bl o o d or m uc us  
- I nf usi o n reacti o n, w h ere y o u ma y feel dizz y or fai nt, fl us he d, get a r as h, ha ve a fe ver, f eel s h ort of breat h, e x perie nce a d ecr ease i n y o ur bl o o d press ure, at t he ti me of recei vi n g y o ur i nf usi o n (I V) or j ust aft er, or pai n at t he site of i nf usi o n.  
- I nfl a m m ati o n of t h e s ki n- y o u m a y h a v e p eeli n g of t h e s ki n, it c hi n ess, s ki n a n d/ or s ki n r e d n ess. T h e s ki n i nfl a m mati o n (i. e. p eeli n g it c hi n g a n d r e d n ess) c o ul d als o b e wi d es pr ea d t hr o u g h o ut y o ur b o d y. M ore se vere s ki n reacti o ns ma y i n v ol ve t he i nsi de of y o ur m o ut h, t he s urface of y o ur e ye a n d ge nital areas, a n d/ or ma y ca use t he t o p la y er of y o ur s ki n t o peel fr o m all o ver y o ur b o d y w hic h ca n ca us e se vere i nfecti o n. T hese se v ere c o n diti o ns ca n s o meti mes lea d t o d eat h. T his ma y be calle d Ste ve ns -J o h ns o n S y n dro me ( SJ S) or T o xic E pi der mal Necr ol ysis ( T E N).

O ut of 1 0 0 pe o pl e w h o recei v e pe m br oliz u ma b, at least 1 b ut less t h a n 5 pe o ple ma y h a ve t h e f oll o wi n g:  
- I nfla m mati o n of t he li ver t hat ma y ma ke y o u feel sic k t o y o ur st o mac h a n d v o mit, feel li ke n ot eati n g,, feel tire d, h a ve a mil d f e ver, h a ve a p ai n i n t he ri g ht si de of y o ur bell y, yell o w e yes a n d s ki n, a n d d ar k uri ne  
- It m a y als o ca use infl a m mati o n of t h e pit uitar y gla n d ( a gl a n d i n t h e h ea d), w hi c h m a y ca us e y o u t o feel si c k t o y o ur st o m ac h or h a ve h ea d ac h es, c h a n ges i n y o ur b e h a vi or, d o u bl e visi o n, fe w t o n o me nstr u al c y cl es, w ea k n ess, v o miti n g a n d di zzi n ess or f ai nti n g.  
- A dr e n al gl a n ds ( o n t o p of t h e ki d n e ys) t h at m a y n ot m a ke e n o u g h h or m o n e, w hi c h ca us es tir e d n ess, w ei g ht l oss, m us cl e w ea k ness, f eeli n g f ai nt, j oi nt, m uscle a n d a b d o mi nal ac hes, na us ea, v o miti n g, l o ose water y st o ols, f e v er, s alt cra vi n g, a n d s o m eti m es dar k e ni n g of t he s ki n li ke a s u nt a n.  
- I nfl a m m ati o n of t h e ki d ne y s o y o u ma y p ass l ess uri n e, or ha v e cl o u d y or bl o o d y uri ne, s w elli n g a n d l o w b ac k p ai n, e v e n t o t h e p oi nt of r e q uiri n g dial ysis.  
- I nfl a m m ati o n of t h e m us cl es s o y o u ma y f eel w ea k or p ai n i n t h e m uscles  
- I nfl a m m ati o n of t h e p a n cr eas ( a gla n d i n y o ur a b d o me n t h at c o ntr ols s u g ar le v els) s o y o u ma y h a v e s e v er e p ai n i n t he t o p p art of y o ur b ell y t h at m a y m o v e t o y o ur bac k, si c k t o y o ur st o mac h, a n d v o miti n g t h at g ets w ors e w h e n y o u eat  
- I nfl a m m ati o n of t he e y e s o y o u m a y h a v e e y e re d ness, bl urre d visi o n, s e nsiti vit y t o li g ht, e y e p ai n, s ee fl o at ers or ha ve h ea d ac h es  
- T y pe 1 Dia betes, a c o n diti o n t hat ca n ca use t o o m uc h s u gar i n y o ur bl o o d, feeli n g t hirstier t ha n us ual, fr e q ue nt uri nati o n a n d wei g ht l oss. Y o u are li kel y t o nee d re g ul ar i ns uli n s h ots.  
- I nfl a m m ati o n of t h e n er v es t h at m a y ca use pai n, wea k n ess or ti n gli n g i n y o ur h a n ds a n d f eet, a n d m a y s pr ea d t o y o ur l e gs, ar ms a n d u p p er b o d y lea di n g t o s e v ere m us cl e w ea k n ess a n d p ossi bl e t e m p or ar y p aral ysis  
- Infla m mati o n of t he mi d dle la yer of y o ur heart wall t hat ma y ca use y o ur heart t o ha v e diffic ult y p u m pi n g bl o o d t hr o u g h o ut y o ur b o d y, w hic h ca n ca use c h est pai n, s h ort ness of breat h a n d s welli n g of t h e le gs. Y o u m a y e x p erie nce a fast or irre g ular h eart beat t hat m a y ca use dizzi ness or f ai nti n g. S o meti mes t his c o n diti o n ca n lea d t o d eat h  
- I nfla m mati o n of t he t h yr oi d gla n d, a n or ga n t hat ma kes a n d st ores t h yr oi d h or m o nes. T his c o n diti o n ma y lea d t o c ha n ge i n y o ur heart rate, bl o o d press ure, b o d y te m perat ur e, a n d t he rate at w hic h f o o d is c o n verte d i nt o e ner g y.  
- A c o n diti o n t hat ma y ma ke y o u feel wea k a n d tire d a n d mi g ht ha ve dr o o pi n g of t he e yeli ds, bl urre d or d o u ble visi o n, diffic ult y s wall o wi n g, sl urre d s peec h, wea k n ess i n y o ur ar ms a n d le gs, or diffic ult y breat hi n g  
- T he f or m ati o n of s mall cl usters of i m m u ne cells (calle d gra n ul o mas) i n parts of y o ur b o d y s uc h as y o ur l y m p h n o des, e yes, s ki n, or l u n gs  
- I nfla m mati o n of t he brai n wit h c o nf usi o n a n d fe v er. T his ma y als o i ncl u d e: dis orie ntati o n, me m or y pr o ble ms, seiz ur es (fits), c ha n ges i n p ers o nalit y a n d be ha vi or, diffi c ult y s pea ki n g, wea k ness or l oss of m o ve me nt i n s o me parts of y o ur b o d y, a n d l oss of c o nsci o us ness A d diti o nall y, si nce pe m br oliz u ma b was a p pr o v e d i n Se pte m ber 2 0 1 4, t he f oll o wi n g si de effects ha ve b ee n re p orte d b y pe o ple r ecei vi n g p e m br oliz u ma b. T hese si de effects w ere v ol u ntaril y re p orte d fr o m a gr o u p of pe o ple of u n k n o w n size. It is n ot p ossi ble t o esti mate t he fre q u e nc y of t his si de effect:  
- I nfla m mati o n of t he j oi nts w hic h ma y i ncl u de j oi nt pai n, stiff ness a n d/ or s welli n g.  
- Se vere r es p o nses of t he i m m u ne s yste m t hat ca use t he b o d y t o attac k its o w n bl o o d cells, s plee n, li ver, l y m p h no d es , s ki n a n d brai n. T his ma y i ncl u de f e ver, ras h, i nfla m mati o n of t he li ver, yell o wi n g of t he s ki n, a n e nlar ge d li v er a n d s plee n, l o w bl o o d c o u nts, a n d e nlar ge d l y m p h n o des. T he ner v o us s yste m ma y als o be affect e d a n d ca use c o nf usi o n, seiz ures, a n d e ve n c o ma.  
If y o u ha v e ha d a n all o ge neic ste m cell tra ns pla nt (a pr o ce d ur e i n w hic h a pers o n recei ves bl o o df or mi n g ste m cells fr o m a d o n or), y o u ma y e x perie nce graft vers us h ost disease ( G v H D), w hic h ma y i ncl u de di arr h ea, s ki n ras hes, a n d li ver da m a ge, after recei vi n g pe m br oliz u ma b. S o meti mes t his c o n diti o n ca n lea d t o deat h.  
If y o u ha ve ha d a s oli d or ga n tra ns pla nt (f or e xa m ple, if y o u ha ve recei ve d a ki d ne y or heart tra ns pla nt), y o u ma y e x p erie nce rej ecti o n of t he tr a ns pla nte d or ga n. Y o ur d oct or will m o nit or y o u a n d s h o ul d tell y o u w hat si g ns a n d s y m pt o ms y o u s h o ul d re p ort de pe n di n g o n t he t y pe of or ga n tra ns pla nt t hat y o u ha ve ha d.

It is n ot k n o w n if t he st u d y dr u g, pe m br oliz u ma b/ Ke ytr u da ma y affect a n u n b or n or n ursi n g ba b y, or has a n a d vers e eff ect o n s per m . If y o u are pre g n a nt, tr yi n g t o bec o me pre g na nt or breast-f ee di n g, y o u ma y n ot be i n t he st u d y. T he st u d y d oct or will perf or m a bl o o d or uri n e pre g na n c y test b ef or e t he start of a n d d uri n g t h e st u d y, if y o u are a ble t o ha ve a b a b y.  
Fe males w h o ar e a ble t o ha ve a ba b y, m ust use 2 met h o ds of birt h c o ntr ol fr o m st u d y Visit 1, d uri n g t he st u d y, a n d f or a p eri o d of 1 2 0 after y o ur last d ose of p e m br oliz u ma b/ Ke ytr u da. T he re q uire me nt t o us e c o ntr ace pti o n d oes n ot a p pl y t o w o me n w h o are p ostme n o pa usal ( a w o ma n w h o is ≥ 4 5 years of a g e a n d has n ot ha d me nses f or great er t ha n 2 years), s ur gicall y sterilize d, or n ot heter ose x uall y acti ve. W o me n of c hil d beari n g p ote ntial m ust use 2 barrier met h o ds, or 1 barrier a n d 1 h or m o nal met h o d, or be a bsti ne nt. T he f oll o wi n g birt h c o ntr ol met h o ds are all o w e d d uri n g t he st u d y:  
Barrier Met h o ds:  
- C o p per I ntra -uteri ne d e vice (I U D)  
- Dia p hra g m  
- S p o n ge  
- C o n d o m ( b y t he part ner)  
- S per mici de  
H or m o nal met h o d:  
- H or m o nal c o ntrace pti ves (s uc h as t he birt h c o ntr ol pill)  
A bsti ne nce ( n o h eter ose x ual acti vit y)  
If y o u bec o me pre g na nt d uri n g t he st u d y y o u m ust n otif y t he st u d y d oct or ri g ht a wa y. T he st u d y dr u g will be st o p pe d a n d y o u will be ta ke n o ut of t he st u d y.  
T here ma y b e ris ks if y o u are male a n d y o ur p art ner is pre g n a nt or tr yi n g t o bec o me pre g n a nt. If y o u are male a n d y o ur part ner is a ble t o ha ve a ba b y, y o u a n d y o ur part ner m ust use 2 met h o ds of birt h c o ntr ol d uri n g t he st u d y a n d f or a peri o d of 1 2 0 da ys after y o ur l ast d ose of pe m br oliz u ma b/ Ke ytr u d a .

T he i nserti o n of t he nee dle t o dra w bl o o d is pai nf ul; h o we ver, t he disc o mf ort is us uall y brief. F or m ost pe o ple, nee dl e p u nct ures t o get bl o o d s a m ples d o n ot ca us e a n y s eri o us pr o ble ms; h o we ver, t he y ma y ca use bl ee di n g, br uisi n g, disc o mf ort, i nfecti o ns, dizzi ness, or f ai nti n g.

We ca n n ot k n o w if y o u will ha ve a n y be nefit as a res ult of y o ur partici pati o n i n t he st u d y; it is p ossi ble t he st u d y treat me nt ma y i m pr o ve y o ur ca ncer, w hic h ma y gi v e y o u relief fr o m s o me s y m pt o ms, i m pr o ve y o ur q ualit y of life or pr ol o n g y o ur s ur vi val. H o we ver, it is p ossi ble t hat y o ur c o n diti o n c o ul d w ors e n. Y o ur p artici pati o n i n t his st u d y will hel p t o o bt ai n i nf or mati o n a b o ut treati n g s u bjects wit h n o n-s mall cell l u n g ca ncer.

If y o u belie ve t hat y o u ar e i nj ure d as a res ult of t h e resear c h pr oce d ures b ei n g perf or m e d, please i m me diatel y c o ntact t he st u d y d oct or. If y o u are i nj ure d b y a me dical treat me nt or pr oce d ure t hat y o u w o ul d ha ve recei ve d e ve n if y o u wer e n't i n t he st u d y, t hat is n ot c o nsi dere d a "researc h i nj ur y".  
I n t he e ve nt t hat a r esear c h acti vit y res ults i n i nj ur y, y o u/ y o ur me dical i ns ura nce m a y be c h ar ge d f or t he c ost of dia g n osi n g a n d treati n g y o ur c o n diti o n. Y o u will be res p o nsi ble f or c o -pa ys or de d ucti bles. A researc h i nj ur y is a n i nj ur y t hat ha p pe ns as a res ult of ta ki n g part i n t his researc h st u d y.  
T he c osts of s uc h me dical car e will be bille d t o y o u or y o ur i ns ura n ce c o m p a n y. T here are n o pla ns t o pr o vi de c o m pe nsati o n f or l ost wa ges, direct or i n direct l osses. T he Cle vela n d Cli nic will n ot v ol u ntaril y pr o vi de c o m pe nsati o n f or researc h rel ate d i nj ur y. Y o u are n ot wai vi n g a n y le gal ri g hts b y si g ni n g t his f or m.  
F urt her i nf or m ati o n a b o ut researc h -rel ate d i nj uries is a vaila ble b y c o ntacti n g t he Cle vela n d Cli nic I nstit uti o nal Re vie w B oar d at ( 2 1 6) 4 4 4- 2 9 2 4.
Clinical trial: NCT02658097
Section: Procedures
Subsections: W H At E Xtr A Tests A N D Pr Oce D Ures Will I H A Ve If I T A Ke P Art I N T His St U D Y ? Bi O Psies|Bl O O D C Ollecti O N|S C R E E Ni N G|F Or R A Di Ati O N Tre At M E Nt|Ge Netic Testi N G|C T Sca Ns|Bi O Psies

M ost of t he e xa ms, tests, a n d pr oce d ures y o u will ha ve are part of t h e us ual a p pr o ac h f or y o ur ca ncer. H o w e ver, t h er e will be a d diti o nal bi o psies d o ne after y o u ha ve starte d t he st u d y dr u g t hat y o u m ust be willi n g t o ha ve if y o u ta ke p art i n t his st u d y. T hese r esearc h bi o psies will be perf or me d o n y o ur t u m or s peci me ns a n d y o ur bl o o d t o u n dersta n d t he fact ors i n t he t u m or t hat ma y i nfl ue nce h o w y o ur ca n cer res p o n ds t o treat me nts.  
A t u m or bi o ps y is t he re m o val of a s mall ( pe n cil eraser -size d) cir cle of t u m or usi n g a c o o kie c utterli ke i nstr u me nt. T he d ur ati o n of t he bi o ps y pr o ce d ure is a p pr o xi matel y 3 0 mi n utes. T he bi o ps y ma y be d o ne b y a r a di ol o gist or a s ur ge o n i n a pr o ce d ure r o o m. T he pr oce d ure will be d o ne usi n g l ocal a nest h esia t o mi ni mize disc o mf ort fr o m t he bi o ps y. T he d oct or will t he n n u m b t he area wit h a l ocal a nest hetic s o t hat t he bi o ps y is less u nc o mf orta ble. T he d oct or will as k y o u t o h ol d y o ur breat h a n d n ot m o ve w hil e he or s he places t h e nee dle i nt o y o ur t u m or a n d wit h dra ws a s m all c ore of tiss ue w hic h r e mai ns tr a p pe d i nsi de t he n ee dle. It is ver y i m p orta nt t hat y o u n ot m o ve or br eat he d uri n g t he bi o ps y.

Bl o o d sa m ples will be c ollecte d t o test f or bi o mar kers t hat hel p resear c hers u n dersta n d t he relati o ns hi p bet wee n t h e st u d y dr u g a n d y o ur t u m or.  
Neit her y o u n or y o ur i ns ura nce c o m pa n y will be c har g e d f or t hes e bi o psies or e xtra bl o o d c ollecti o ns.

- T he st u d y d oct or will re vie w:  
o Y o ur me dical hist or y o A n y pri or or c o nti n ui n g me dicati o ns o A n y pri or treat me nt(s) y o u ma y ha ve ha d f or y o ur ca ncer  
- Y o u will be as ke d a b o ut y o ur healt h  
- Y o u will ha ve a c o m plet e p h ysical e xa m  
- Y o ur vital si g ns will be ta ke n( bl o o d pr ess ure, h eart rate, te m perat ure, breat hi n g rate)  
- Y o ur hei g ht a n d w ei g ht will be meas ure d  
- R o uti ne bl o o d a n d uri ne sa m ples will be c ollecte d t o c hec k y o ur h ealt h a n d stat us of y o ur disease o T o c hec k t he f u ncti o n of y o ur or ga ns f or saf et y.  
o T o perf or m a pre g n a nc y t est f or fe m ales w h o are a ble t o ha ve c hil dre n.  
- E xtra bl o o d c ollecti o n f or e x pl orat or y bi o mar ker assess me nts t hat hel p res earc h ers u n dersta n d t he r elati o ns hi p bet wee n t he st u d y dr u g a n d y o ur t u m or (t hat is ge netic st u dies).  
- If y o u ar e a w o ma n:  
o W h o is a ble t o bec o me pre g na nt y o u will be as k e d t o ha ve a ser u m pre g na nc y test t hat re q uires a b o ut 1 ml (l ess t ha n half a teas p o o n) of bl o o d ser u m, or a uri ne pre g na nc y t est; o If y o u ar e c o nsi dere d p ost me n o pa usal or u na ble t o re pr o d uce, y o u ma y be as ke d t o ha ve differe nt bl o o d test t o test a h or m o ne i n y o ur b o d y t hat deter mi nes y o ur a bilit y t o bec o me pre g na nt. T his test re q uires a b o ut 1 ml (less t ha n half a teas p o o n) of bl o o d.  
D uri n g y o ur visits t o t he d oct or, y o u will ha ve e xtra bl o o d dra w n b y t a ki n g a d diti o nal bl o o d fr o m a vei n i n y o ur ar m ( u p t o 3 o u nces) d uri n g eac h st u d y visit . If y o u ha v e ha d a pr e vi o us t u m or bi o ps y, y o u ma y be eli gi ble t o use y o ur ol d t u m or sa m ples. If y o u d o n ot ha ve ar c hi ve d t u m or tiss ue, y o u will be re q uire d t o ha v e a n e w bi o ps y (fres h tiss ue sa m ple ta ke n) at t he ti me of scree ni n g, u nless w ai ve d b y t he s p o ns or.  
B l o o d a n d tiss ue sa m ples t hat are c ollecte d b y t he st u d y d oct or will be pr o vi de d t o c olla b orat ors w h o s pecialize i n a nal yzi n g t he t u m or D N A, pr otei ns a n d t he i m m u ne cells. We will re q uest f or r e vie w of y o ur CT Sca ns t o deter mi ne t he l ocati o n of t he t u m or f or t he bi o ps y a n d t he ra diati o n.  
Please ma ke y o ur st u d y d oct or a war e if y o u are r ecei vi n g car e else w h ere or pla n t o recei ve care  
else w her e w hile o n t his st u d y.  
T he f oll o wi n g list of t her a pies ar e pr o hi bite d w hile o n t he s cree ni n g a n d tr eat me nt peri o d of t his st u d y:  
- Ot her ca n cer t hera pies i n cl u di n g i m m u n ot hera p y a n d c he m ot her a p y n ot s pecifie d i n t his pr ot oc ol.  
- Ot her i n vesti gati o nal a ge nts o utsi de of pe m br oliz u ma b.  
- Li ve vacci nes pri or t o t he first d os e of trial treat me nt a n d w hile partici pati n g o n trial treat me nt. E xa m ples of li ve vacci nes i ncl u de, b ut are n ot li mite d t o, t he f oll o wi n g: measles, m u m ps, r u bella, varicella/z oster, yell o w fe v er, r a bies, B C G, a n d t y p h oi d vacci ne.  
- S yste m -wi de ster oi ds f or a n y p ur p ose ot her t ha n a n e ve nt of cli nical i nterest s us pecte d t o be ori gi nati n g fr o m t he i m m u ne s yste m. S h ort c o urses of ster oi ds u nr elate d t o st u d y treat me nt c o ul d be a p pr o ve d after c o ns ultati o n wit h y o ur treati n g p h ysicia n a n d t he s p o ns or.  
Please reac h o ut t o y o ur treati n g p h ysicia n if y o u ha ve bee n pres cri be d or pla n t o ta ke a n y of t he a b o ve t her a pies t hr o u g h o ut t he c o urse of t his st u d y.

T he ris ks of ra diati o n ar e relate d t o t he part of t he b o d y t hat is ra diate d. All ra diati o n o n t his st u d y is bei n g d o ne as "sta n dar d of car e", mea ni n g t hat t he d ose a n d t he r e gi me n of r a diati o n t hat is bei n g use d is a d ose t hat is r o uti nel y use d t o treat l u n g ca ncer f or i m pr o vi n g s y m pt o ms fr o m t he ca ncer. T h e m ost c o m m o n si de effect ( 3 0 - 5 0 %) of ra diati o n is mil d fati g ue w hic h ma y last f or u p t o 1-2 m o nt hs after treat me nt. T he s pecific part(s) of t he b o d y r a diate d will be deter mi ne d b y y o ur me dical tea m, wit h ra diati o n gi ve n t o ca ncer c o ntai ni n g re gi o ns w hic h are ca usi n g y o u s y m pt o ms f or t he p ur p ose of relie vi n g t hese s y m pt o ms.  
Ra diati o n t o b o ne or m uscle pr o d uces mi ni mal si de effects, t h o u g h occasi o nall y ca ncer r elate d b o ne pai n ma y i ncreas e sli g htl y f or 1 2 -2 4 h o urs after t he first tr eat me nt ( pri or t o i m pr o vi n g 5 - 1 4 da ys after ra diati o n).  
Ra diati o n t o t he s ki n ma y pr o d uce a mil d dar ke ni n g of t he s ki n si milar t o a s u nta n, as well as dr y ness i n t he s ha pe of t he ra diati o n fiel d. T his t y picall y occ urs 5 -1 0 da ys after ra diati o n, b ut s h o ul d be relati vel y rare at t his treat me nt d ose (less t ha n < 1 0 %).  
Ra diati o n t o t he b o wel or st o mac h ma y pr o d uce na usea or diarr h ea ( 2 0 % at t his d ose le vel). If nee de d, a p pr o priat e me di cati o n will be prescri be d b y y o ur me dical tea m t o relie ve s y m pt o ms.  
Ra diati o n t o t he l u n gs ma y pr o d uce mil d scari n g, t h o u g h at t his d ose le vel t his w o ul d be e xtre mel y rare ( < 1 %).  
Ra diati o n e x p os ure ca n ca use ris k of de v el o pi n g a sec o n d ca n cer 5 -2 0 years aft er ra di ati o n e x p os ure, t h o u g h t he ris k of t his is ver y l o w ( < 1 p er 5, 0 0 0 patie nts treate d).  
W h at Are T he P ossi ble Ris ks Wit h T he Rese arc h A n al ysis O n T he T u m or a n d Bl o o d ?  
P h ysical ris ks wit h t his st u d y are n o differe nt fr o m t he ris k of ha vi n g bl o o d ta ke n f or r o uti ne cli nical practice a n d ris ks ass ociate d wit h t he r esearc h bi o psies as des cri be d a b o ve.

Ris ks of bei n g i n ge netic testi n g i ncl u de t he mis use of pers o nal, ge n etic i nf or mati o n. All pers o n nel w h o will ha ve access t o ge netic i nf or mati o n a b o ut y o u are et hicall y a n d le gall y o bli gate d t o mai ntai n t he c o nfi de nce of t hat i nf or mati o n. H o we ver, t here ca n b e n o a bs ol ute g uara ntees.  
Alt h o u g h rare, mis use of s uc h i nf or mati o n has ca use d pr o ble ms f or pers o ns relate d t o t heir e m pl o y me nt a n d/ or t heir life a n d/ or healt h i ns ura n ce a n d ot her be nefits or e ntitle me nts.  
T he r esearc hers will use c o m merciall y reas o n a ble eff orts t o pr ot ect y o ur c o nfi de ntialit y b y usi n g c o des t o i de ntif y a n d tr ac k y o ur sa m ples. T he s a m ples a n d a n y pers o nal st u d y data c ollecte d fr o m y o u, as well as t he c o m pl ete res ear c h dat a, will n ot be la bele d wit h a n y i nf or mati o n s uc h as y o ur na me, c o ntact i nf or mati o n, or date of birt h.  
If t he researc h ers s har e y o ur st u d y data or y o ur sa m ples wit h o utsi de researc h ers, t he o utsi de researc hers m ust pr o mise n ot t o use i nf or mati o n fr o m y o ur ge n es or pr otei ns t o i de ntif y or c o ntact y o u.  
T here is a ris k t hat s o me o ne c o ul d gai n access t o y o ur sa m ples, or t he pers o nal r esearc h i nf or mati o n fr o m t h e st u d y of y o ur sa m ples. E v e n wit h o ut y o ur na m e or ot her i de ntifiers, y o ur ge netic i nf or mati o n is u ni q ue t o y o u. If f ut ur e res earc h is d o ne o n y o ur g e nes a n d pr otei ns, t here is a c h a nce t hat s o me o n e c o ul d lear n a b o ut y o ur ris k f or cert ai n diseas es a n d li n k t hat i nf or mati o n bac k t o i de ntif y y o u. I n s o me cases, it c o ul d be use d t o ma ke it har der f or y o u t o get or kee p a j o b or i ns ura nce.

If y o u ta ke part i n t his resear c h, y o u will ha ve o ne or m ore me dical i ma gi n g st u dies w hic h use ra diati o n. T he ra di ati o n d ose we ha ve disc uss e d is w hat y o u will recei ve fr o m t his st u d y o nl y, a n d d oes n ot i ncl u de a n y e x p os ure y o u ma y n ot ha ve recei ve d or will recei ve fr o m ot her tests. T he C T  
sca n t hat y o u will recei ve i n t his st u d y will e x p ose y o u t o l o w a m o u nts of ra diati o n. E ver y da y, pe o ple are nat ur all y e x p ose d t o l o w le vels of ra diati o n t hat c o me fr o m t he s u n a n d t he e n vir o n me nt.  
T his t y pe of ra diati o n is calle d " bac k gr o u n d ra diati o n." N o o ne k n o ws f or s ure w het her e x p os ure t o l o w a m o u nts of ra diati o n is har mf ul f or y o ur b o d y. H o we ver, scie ntists belie ve t hat bei n g e x p ose d t o t o o m uc h ra diati o n ca n ca use h ar mf ul si de effects, i ncl u di n g ca usi n g a ne w ca nce r. T he a m o u nt of ra diati o n t hat scie ntists t hi n k ca n ca use har mf ul si de eff ects e q u als m ore t ha n 1 5 ti mes t he a m o u nt of e xtra r a diati o n y o u w o ul d recei ve fr o m bei n g i n t his st u d y. Als o, scie ntists belie ve t he n u m ber of pe o ple w h o w o ul d be at ris k f or de vel o pi n g a sec o n d ca n cer fr o m bei n g e x p ose d t o lar ge a m o u nts of r a diati o n t o be a b o ut 1 o ut of e ver y 1, 0 0 0.  
X- ra y We are all e x p ose d t o ra diati o n o n a dail y basis b ot h fr o m nat ural (s u n a n d eart h) a n d ma n -ma de s o urces t hat we call bac k gr o u n d ra diati o n. T he a m o u nt of ra diati o n fr o m a n x- ra y is l o wer t ha n w hat y o u are e x p ose d t o t hr o u g h nat ural s o urces of ra diati o n i n t he e n vir o n me nt.  
T he x -r a y tec h n ol o gists a n d ra di ol o gists use t he s mallest p ossi ble d ose of r a diati o n a n d pr o vi d e a pr otecti ve lea d a pr o n w h e n m ulti ple x- ra ys ar e necessar y.

Ris ks ass ociate d wit h bi o psies i ncl u de pai n, re d n ess, s welli n g, l o w bl o o d pr ess ure, e xcessi ve blee di n g, br uisi n g, or drai ni n g at t he nee dle site, a b n or mal w o u n d heali n g, fe ver, i nfecti o n, a n d aller gic r eacti o n t o t he me dicati o n use d t o n u m b t he s ki n o ver t he bi o ps y site. T w o t o 3 % of patie nts re q uire h os pitalizati o n after a t u m or bi o ps y. Rar el y, a n i nfecti o n ca n o cc ur . T he ris ks i n v ol ve d wit h t he bi o ps y de pe n d o n t he l ocati o n of t he t u m or t hat has t o be bi o psie d. Y o ur p h ysicia n will deter mi ne t he safest ar e a of t he t u m or t o bi o ps y a n d t he ris ks of t he pr oce d ure will be disc usse d i n detail pri or t o t he pr oce d ure b y t h e p h ysicia n perf or mi n g t he bi o ps y. Ver y rar el y, a c o m plicati o n fr o m ha vi n g a bi o ps y c o ul d be fat al.  
Ris ks s pecificall y ass oci ate d wit h l u n g bi o ps y are p ne u m ot h ora x ( c olla ps e of l u n g), air e m b ol us  
(air i n a bl o o d vess el), he m o pericar di u m ( bl o o d ar o u n d t he heart), a n d l u n g t orsi o n (t wisti n g t hat i nterr u pts t he bl o o d s u p pl y t o t he l u n g).  
Let y o ur st u d y d oct or k n o w of a n y q u esti o ns y o u ha ve a b o ut p ossi ble si de effects. Y o u ca n as k t h e st u d y d oct or q uesti o ns a b o ut si de effects at a n y ti me.
Clinical trial: NCT02658097
Section: Purpose of Research
Subsections: C O N S E N T F O R C A N C E R R E S E A R C H|W H Y Is T His St U D Y Bei N G D O Ne ?

Pr oject Title: A P hase II Trial of P e m br oliz u ma b Se q ue ntiall y F oll o wi n g Si n gle F racti o n N o nA blati ve R a diati o n t o O ne or M ore of t he T ar get L esi o ns i n P atie nts wit h S ta ge I V N S C L C ( C A S E  
1 5 1 6)  
Cli nic al Tri als Re gistr ati o n N u m ber: N C T 0 2 6 5 8 0 9 7 S p o ns or: Cle vela n d Cli nic/ Case C o m pre he nsi ve Ca ncer Ce nter  
Pri nci p al I n vesti g at or: N at h a n Pe n nell, M D, P h D  
Cle vela n d Cli nic F o u n dati o n  
Ca ncer resear c h st u dies are c o or di n ate d b y p h ysicia ns a n d s cie ntists fr o m Cle vela n d Cli nic, U ni versit y H os pitals a n d Case Wester n Res er ve U ni versit y ( C W R U) t hr o u g h t he NI H Nati o nal Ca ncer I nstit ute ( N CI) d esi g nate d Case C o m pre h e nsi ve Ca ncer Ce nter ( C ase C C C). T he g oal of t his c olla b orati o n is t o e n ha nce ca ncer treat me nt a n d researc h i n N ort heast O hi o. T his st u d y is bei n g offer e d l ocall y at Cle vela n d Cli nic Mai n, C C re gi o nal sites i ncl u di n g: Hillcrest H os pital, Fair vie w H os pital, Str o n gs ville Fa mil y Healt h Ce nter ( F H C), a n d C C Fl ori da.  
E xter nal sites i ncl u de R us h U ni versit y Me dical Ce nter, R os well Par k I nstit ute, a n d Alle g ha n y Me m orial H os pital .  
W h at is t he Us u al A p pr o ac h t o M y St a ge I V N o n -S m all Cell L u n g C a ncer ( N S C L C)?  
T he m ost c o m m o n treat me nt a p pr oac h t o y o ur ca ncer is treat me nt wit h c he m ot hera p y or a n i m m u n ot hera p y. Palliati ve l o w d ose ra di ati o n (s uc h has t he o ne b ei n g st u die d her e ) is c o nsi der e d sta n dar d treat me nt i n patie nts w h o ha ve ca ncer r elate d s y m pt o ms.

E ve n t h o u g h i m m u n ot hera p y treat me nts s uc h as pe m br oliz u ma b ar e ne w m o des of treat me nt f or patie nts wit h l u n g ca ncer, o nl y a b o ut 2 0 -3 0 % of patie nts res p o n d t o s uc h treat me nts. Rece nt researc h h as s h o w n t hat r a diati o n treat me nt t o ca n cers ca n i n crease t h e a bilit y of patie nts' i m m u ne s yste m t o rec o g nize ca ncer, a n d c o ul d s er ve as a usef ul a d diti o n t o i m m u n ot hera p y treat me nts.  
T he p ur p ose of t his st u d y is t o deter mi ne if l o w si n gle palliati ve d ose ra diati o n t o t he l u n g ca ncer will i m pr o ve y o ur i m m u ne res p o nse a gai nst t he t u m or, a n d if se q ue ntial treat me nt wit h pe m br oliz u ma b (st u d y dr u g) w o ul d offer s u peri or res ults t o pe m br oliz u ma b al o ne. Pe m br oliz u ma b is a n F D A a p pr o ve d dr u g (als o k n o w n as Ke ytr u da), w hic h has bee n a p pr o ve d b y t he F D A f or use i n l u n g ca ncer a n d certai n t y pes of s ki n ca n cer ( mela n o m a). Pe m br oliz u ma b is a m o n ocl o nal a nti b o d y t hat bi n ds t o t he s urf ace of s o me cells of t he i m m u n e s yste m a n d acti vates t he m a gai nst ca ncer cells. It is n ot c he m ot hera p y.  
T he p ur p ose of t his researc h is als o t o st u d y w het her t here ar e a n y c ha n g es prese nt i n t he D N A,  
R N A, a n d pr otei ns wit hi n y o ur t u m or or t he bl o o d cells t hat ma y c o ntri b ute t o a res p o nse t o t he st u d y treat me nt or pr o gr essi o n of ca ncer. T his researc h will st u d y y o ur g e n o me. T he ge n o me is t he c om plete set of y o ur ge nes. Y o ur g e nes are ma de u p of D N A, w hic h c o ntai ns t he c o de f or ma ki n g a pr otei n. D N A gi ves i nstr ucti o ns t o R N A t o ma ke pr otei ns. Researc h o n ge nes is calle d ge n o mic researc h, res ear c h o n R N A is calle d tra nscri pt o mic resear c h, a n d researc h o n lar ge sets of pr otei ns is calle d pr ote o mic researc h. T his res earc h als o l o o ks at h o w y o ur ge nes are "t ur ne d o n" or "t ur n e d off " t o gi ve t he messa ges t hat pr o m pt t he ma ki n g of pr otei ns.  
T his researc h ma y h el p t he resear c hers i n t he f ut ure t o lear n m ore a b o ut t he ca uses, ris ks, treat me nts, or pre v e nti o n of ca ncers a n d ot her healt h pr o ble ms. T he researc h ma y b e use d t o de vel o p ne w i deas a n d me dical pr o d u cts, i ncl u di n g dr u gs, i njecti o ns, a n d dia g n ostic tests. Y o u will n ot o w n a n y i d ea or pr o d uct cr eate d b y t he researc h ers usi n g y o ur sa m ples. Y o u will n ot recei v e a n y pa y m e nt or fi na ncial be n efit fr o m t he creati o n, use, or sale of s uc h a pr o d uct or i dea.
Clinical trial: NCT02658097
Section: Voluntary Participation
Subsections: Voluntary Participation

Your participation in this research study is voluntary. Choosing not to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are otherwise entitled.  
If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits. If information generated from this study is published or presented, your identity will not be revealed. In the event new information becomes available that may affect the risks or benefits associated with this study or your willingness to participate in it, you will be notified so that you can decide whether or not to continue participating.
Clinical trial: NCT02658097
Section: Withdrawal from Study
Subsections: W H At Will H A P Pe N If I T A Ke P Art I N T His St U D Y ?|C A N I St O P T A Ki N G P Art I N T His St U D Y ?

If y o u a gr ee t o ta ke part i n t his researc h y o u will be as k e d t o si g n t he st u d y c o nse nt. T he st u d y i ncl u des a scree ni n g p eri o d, a c or e or treat me nt p h ase, a n d a p ost st u d y ( o bs er vati o n) p h ase. D uri n g t he scree ni n g p has e t he r esear c h tea m will perf or m a seri es of t ests t o deter mi ne if y o u are eli gi ble f or t he st u d y.

Yes. Y o u ca n deci d e t o st o p at a n y ti me. If y o u d eci de t o st o p f or a n y reas o n, it is i m p orta nt t o let t he st u d y d oct or k n o w as s o o n as p ossi ble s o y o u ca n st o p safel y. If y o u st o p, y o u ca n d eci de w het her or n ot t o l et t h e st u d y d oct or c o nti n ue t o pr o vi de y o ur me dical i nf or mati o n t o t he or ga nizati o n r u n ni n g t he st u d y.  
T he st u d y d oct or will tell y o u a b o ut ne w i nf or mati o n or c ha n ges i n t he st u d y t hat ma y affect y o ur healt h or y o ur willi n g ness t o c o nti n ue i n t he st u d y.  
T he st u d y d oct or ma y ta k e y o u o ut of t he st u d y:  
If y o ur healt h c ha n ges a n d t he st u d y is n o l o n ger i n y o ur best i nterest If ne w i nf or mati o n bec o mes a vaila ble If y o u d o n ot f oll o w t he st u d y re q uire me nts If t he st u d y is st o p pe d b y t he s p o ns or, I nstit uti o nal Re vie w B oar d (I R B) or F D A.  
If y o u bec o m e pre g n a nt