Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing

Official Title

Avelumab Master Protocol: An Open-label Continuation Study for Participants Continuing From Pfizer-sponsored Avelumab Clinical Studies.

Summary:

This Master Protocol for Avelumab Continuation Sub-Studies is to provide continued treatment access, safety follow-up, and when applicable, overall survival follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer-sponsored Avelumab parent studies.

Trial Description

Primary Outcome:

• Number of participants with adverse events leading to permanent discontinuation of study intervention
• Number serious adverse events reported for all participants

B9991046 is a master protocol that will consist of sub-studies from the following parent studies: B9991001

• NCT02603432 B9991004

• NCT02554812 B9991005

• NCT02584634 B9991009

• NCT02580058 B9991023

• NCT03317496 B9991025

• NCT03330405 B9991027

• NCT03472560 B9991032

• NCT03565991

View this trial on ClinicalTrials.gov