Phase 2 Study of Talimogene Laherparepvec in Combination With Pembrolizumab in Subjects With Unresectable/Metastatic Stage IIIB-IVM1d Melanoma Who Have Progressed on Prior Anti PD-1 Based Therapy
Phase: PHASE2
Conditions: Melanoma
Sponsor: Amgen

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Product:  Talimogene Laherparepvec
Protocol Number:  20180115
Date:  10 March 2020
Page 1 of 27
CONFIDENTIAL
Amendment 2
Protocol Title:  Phase 2 Study of Talimogene Laherparepvec in Combination With 
Pembrolizumab in Subjects With Unresectable/Metastatic Stage IIIB-IVM1d 
Melanoma Who Have Progressed on Prior Anti PD-1 Based Therapy
Amgen Protocol Number (talimogene laherparepvec) 20180115
EudraCT number 2019-001906-61
NCT number:  NCT04068181
Amendment Date:
10 March 2020
Rationale:
This protocol is being amended to:
!
Add new exclusion criterion to exclude subjects who experience disease progression 
on more than 1 line of prior anti-programmed cell death-1 (PD-1) therapy.
!
Align contraception requirements with Amgen Global Protocol template, including 
updates to and addition of new exclusion criterion for male subjects
!
Align with the program level frequency of follow-up for patients who achieve a 
complete response. 
!
Add a Per Protocol Analysis Set (PPAS), which is a subset of the Full Analysis Set 
(FAS) in the efficacy analysis
!
Update Table 7-2 – Dose Modification and Toxicity Management Guidelines for 
Immune-related Adverse Events Associated with Pembrolizumab to align with the 
Keytruda∀European Union (EU) Summary of Product Characteristics (SmPC).
!
Clarify Tumor Response Assessments:
#
Correct administrative/grammatical errors
!
Administrative, typographical, and formatting changes were made throughout the 
protocol.
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