A Phase 1b Open Label Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adult Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Phase: PHASE1
Conditions: Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Sponsor: Amgen

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Product:  Blinatumomab
Protocol Number:  20150290
Date:  08 March 2018
Page 1 of 70
CONFIDENTIAL
Amendment 2
Protocol Title:  A Phase 1b Open Label Study Investigating the Safety and Efficacy 
of Blinatumomab in Combination With Pembrolizumab in Adult Subjects With 
Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) 
Amgen Protocol Number Blinatumomab 20150290
Merck Protocol Number PN348
Eudra CT number 2016-002191-27
Amendment Date:
08 March 2018
Rationale:
This protocol is being amended to:
!
Update Merck investigational product background information (pembrolizumab) and
rationale for dose selection
!
Include language about addition of pembrolizumab to blinatumomab dosing per once
blinatumomab target dose has been reached.
!
Update End of Study language per new protocol template.
!
Update Exclusion Criteria #222 to indicate that subjects who have quantifiable
hepatitis b virus are excluded.
!
Add Exclusion Criteria #227 for history of solid organ transplant.
!
Update dose modification for pembrolizumab (text and table).
!
Update concomitant medication language per Merck text.
!
Add hepatitis antibody testing at screening and hepatitis virus testing throughout
study.
!
Add neurological exam to physical exam.
!
Clarify PK language for expansion cohort.
!
Add suspected unexpected serious adverse reaction (SUSAR) language to safety
section.
!
Clarify ± 3 day window for pembrolizumab-related assessments
!
Make administrative and editorial changes.
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