Trials / Active Not Recruiting
Active Not RecruitingNCT05059522
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Avelumab | oral |
| DRUG | Lorlatanib | oral |
| DRUG | Talazoparib | oral |
| DRUG | Pemetrexed | IV (intravenous) infusion |
| DRUG | Axitinib | oral |
| DRUG | CMP 001 | IT (intratumoral) or SC (subcutaneous) |
| DRUG | Utomilumab | IV infusion |
| DRUG | PF04518600 | IV infusion |
Timeline
- Start date
- 2021-09-29
- Primary completion
- 2026-09-30
- Completion
- 2026-09-30
- First posted
- 2021-09-28
- Last updated
- 2026-04-14
Locations
71 sites across 19 countries: United States, Australia, Belgium, Canada, Denmark, France, Hungary, Israel, Italy, Japan, Mexico, New Zealand, Poland, Russia, Serbia, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05059522. Inclusion in this directory is not an endorsement.