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

Phase 3

Active, not recruiting

• Conditions: Advanced Malignancies; NSCLC; Ovarian Cancer; Urothelial Cancer; Solid Tumors
• Interventions: Drug: Avelumab; Drug: CMP 001; Drug: Lorlatanib; Drug: Pemetrexed; Drug: Talazoparib; Drug: Axitinib; Drug: Utomilumab; Drug: PF04518600

• Registration Number: NCT05059522
• Lead Sponsor: Pfizer

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

Study Timeline

• Study First Submitted: 2021-09-17
• Study First Submitted QC: 2021-09-17
• Study First Posted: 2021-09-28
• Study Start: 2021-09-29
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-20
• Last Update Posted: 2025-06-25
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Avelumab	Avelumab monotherapy as specified by sub-study protocol B9991001C
Arm 2	Avelumab	Avelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C
Arm 2	CMP 001	Avelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C
Arm 2	Utomilumab	Avelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C
Arm 2	PF04518600	Avelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C
Arm 6	Avelumab	Avelumab in combination with Talazoparib as specified by sub-study B9991025C.
Arm 3	Avelumab	Avelumab in combination with Loratanib as specified by sub-study protocol B9991005C
Arm 3	Lorlatanib	Avelumab in combination with Loratanib as specified by sub-study protocol B9991005C
Arm 4	Avelumab	Avelumab monotherapy as specified by sub-study protocol B9991009C
Arm 5	Avelumab	Avelumab monotherapy or in combination with Pemetrexed as specified by sub-study protocol B9991023C
Arm 5	Pemetrexed	Avelumab monotherapy or in combination with Pemetrexed as specified by sub-study protocol B9991023C
Arm 6	Talazoparib	Avelumab in combination with Talazoparib as specified by sub-study B9991025C.
Arm 7	Avelumab	Avelumab in combination with Axitinib as specified by sub-study B9991027C.
Arm 7	Axitinib	Avelumab in combination with Axitinib as specified by sub-study B9991027C.
Arm 8	Avelumab	Avelumab in combination with Talazoparib as specified by sub-study B9991032C.
Arm 8	Talazoparib	Avelumab in combination with Talazoparib as specified by sub-study B9991032C.
Arm 9	Avelumab	Avelumab in combination with Axitinib as specified by sub-study protocol B9991003C
Arm 9	Axitinib	Avelumab in combination with Axitinib as specified by sub-study protocol B9991003C

Primary Outcome Measures

Name	Time	Method
Number serious adverse events reported for all participants	Baseline up to approximately 5 years
Number of participants with adverse events leading to permanent discontinuation of study intervention	Baseline up to approximately 5 years

Trial Locations

Locations (64)

Highlands Oncology Group, PA; 🇺🇸 Springdale, Arkansas, 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

MSK Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center 53rd street.; 🇺🇸 New York, New York, United States

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