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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05059522
Enrollment
68
Registered
2021-09-28
Start date
2021-09-29
Completion date
2026-09-30
Last updated
2025-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Malignancies, NSCLC, Ovarian Cancer, Urothelial Cancer, Solid Tumors

Keywords

BRCA Mutant Tumors, ATM Mutant Tumors

Brief 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.

Detailed description

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

Interventions

DRUGAvelumab

oral

DRUGLorlatanib

oral

DRUGTalazoparib

oral

DRUGPemetrexed

IV (intravenous) infusion

DRUGAxitinib

oral

DRUGCMP 001

IT (intratumoral) or SC (subcutaneous)

DRUGUtomilumab

IV infusion

DRUGPF04518600

IV infusion

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Any participant who is receiving study treatment and deriving significant clinical benefit or is in the safety and/or survival follow-up period in a Pfizer-sponsored Avelumab Parent Study. 2. Participants must agree to follow the reproductive criteria. 3. Participants must be willing and able to comply with all scheduled visits, treatment plan, and other study procedures.

Exclusion criteria

1. Female participants who are pregnant or breastfeeding. 2. Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Number of participants with adverse events leading to permanent discontinuation of study interventionBaseline up to approximately 5 years
Number serious adverse events reported for all participantsBaseline up to approximately 5 years

Countries

Australia, Belgium, Canada, Denmark, France, Hungary, Israel, Italy, Japan, Mexico, New Zealand, Poland, Russia, Serbia, South Korea, Spain, Taiwan, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026