A Phase IB/II Study of Nivolumab In Combination With ALT-803 In Patients With Pretreated, Advanced, or Metastatic Non-Small Cell Lung Cancer
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
Sponsor: Medical University of South Carolina

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C T O #  1 0 2 3 2 3  
Pr ot oc ol versi o n date: Se pte m ber 4, 2 0 1 8  
 
4 
 
 
5. 3. 1  N o n -I m m u ne-Relat e d A d verse E ve nts  ................................................................. 3 8 
5. 3. 2  I m m u ne-Relate d A d v ers e E ve nts  ......................................................................... 3 9 
5. 4  Pre a n d P ost T her a p y I nter ve nti o n G ui deli nes ............................................................ 4 0 
5. 4. 1  A L T - 8 0 3 O bser vati o n Re q uire me nts .................................................................... 4 1 
5. 4. 2  Ni v ol u ma b O bser vati o n Re q uire me nts  ................................................................. 4 1 
5. 5  S u p p orti ve C are G ui deli nes  ........................................................................................... 4 2 
5. 5. 1  H y p ote nsi o n a n d C L S  ........................................................................................... 4 2 
5. 5. 2  H y p o ma g n ese mia  .................................................................................................. 4 3 
5. 5. 3  C oa g ulati o n  ........................................................................................................... 4 3 
5. 5. 4  I m paire d ki d ne y a n d li ver f u ncti o ns ..................................................................... 4 3 
5. 5. 5  I nfecti o n ................................................................................................................ 4 3 
5. 5. 6  Fe ver a n d C hills .................................................................................................... 4 3 
5. 5. 7  Gastritis  ................................................................................................................. 4 3 
5. 5. 8  Diarr hea, Na us ea a n d V o miti n g  ............................................................................ 4 3 
5. 5. 9  Pr urit us a n d Der matitis  ......................................................................................... 4 3 
5. 5. 1 0  Aci d osis ................................................................................................................. 4 3 
5. 5. 1 1  Lif e T hreate ni n g T o xicities  ................................................................................... 4 3 
5. 5. 1 2  Ot her S u p p orti ve Care  .......................................................................................... 4 4 
6  T R E A T M E N T M O DI FI C A TI O N S  .................................................................................... 4 5 
6. 1  Tre at me nt m o dific ati o ns f or A Es n ot s pecifie d else w here i n t he pr ot oc ol  ................ 4 5  
7  D R U G I N F O R M A TI O N  ...................................................................................................... 4 6 
7. 1  A L T - 8 0 3 (I L- 1 5 N 7 2 D:I L- 1 5 RS u/I g G 1 Fc c o m ple x)  ................................................ 4 6 
7. 1. 1  Descri pti o n  ............................................................................................................ 4 6 
7. 1. 2  M o de of Acti o n  ..................................................................................................... 4 6 
7. 1. 3  T o xicit y  ................................................................................................................. 4 6 
7. 1. 4  St ora ge  .................................................................................................................. 4 6 
7. 1. 5  Pac ka gi n g  .............................................................................................................. 4 7 
7. 1. 6  La b eli n g  ................................................................................................................ 4 7 
7. 1. 7  Treat me nt Pre p arati o ns a n d A d mi nistrati o n  ......................................................... 4 7 
7. 1. 8  Safet y Pr eca uti o ns  ................................................................................................. 4 7 
7. 1. 9  Te m perat ur e E x c ursi o n  ......................................................................................... 4 7 
7. 1. 1 0  Dr u g Destr u cti o n  ................................................................................................... 4 7 
7. 2  O p di v o ( Ni v ol u m a b)  ....................................................................................................... 4 7 
7. 2. 1  Descri pti o n  ............................................................................................................ 4 8 
7. 2. 2  T o xicit y  ................................................................................................................. 4 8 
8  C O N C O MI T A N T M E DI C A TI O N S  ................................................................................... 4 8 
8. 1  Per mitte d Me dic ati o ns – Use wit h C a uti o n  .................................................................. 4 8 
8. 2  Pr o hi bite d Me dic ati o ns  .................................................................................................. 4 8 
9  S T U D Y A S S E S S M E N T S  ..................................................................................................... 4 9 
9. 1  Ge ner al C o nsi der ati o ns  .................................................................................................. 4 9 
9. 2  Me dic al Hist or y a n d Pri or T her a p y  .............................................................................. 5 0 
9. 3  P re g n a nc y Test  ................................................................................................................ 5 0 

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