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.
B9991046 is a master protocol that will consist of sub-studies from the following parent studies: B9991001 - NCT02603432 B9991003 - NCT02684006 B9991004 - NCT02554812 B9991005 - NCT02584634 B9991009 - NCT02580058 B9991023 - NCT03317496 B9991025 - NCT03330405 B9991027 - NCT03472560 B9991032 - NCT03565991
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
77
Number of participants with adverse events leading to permanent discontinuation of study intervention
Time frame: Baseline up to approximately 5 years
Number serious adverse events reported for all participants
Time frame: Baseline up to approximately 5 years
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IV (intravenous) infusion
oral
IT (intratumoral) or SC (subcutaneous)
IV infusion
IV infusion
Highlands Oncology Group, PA
Fayetteville, Arkansas, United States
Highlands Oncology Group, PA
Rogers, Arkansas, United States
Highlands Oncology Group, PA
Springdale, Arkansas, United States
The Regents of the University of California
Los Angeles, California, United States
UCLA Hematology/Oncology
Los Angeles, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
MSK Basking Ridge
Basking Ridge, New Jersey, United States
MSK Monmouth
Middletown, New Jersey, United States
MSK Bergen
Montvale, New Jersey, United States
MSK Commack
Commack, New York, United States
...and 61 more locations