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

Pfizer

Status and phase: Active, not recruiting; Phase 3

Conditions: Advanced Malignancies; Urothelial Cancer; Solid Tumors; Ovarian Cancer; NSCLC

Treatments: Drug: Utomilumab; Drug: Axitinib; Drug: CMP 001; Drug: Lorlatanib; Drug: PF04518600; Drug: Pemetrexed; Drug: Talazoparib; Drug: Avelumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05059522

2023-509466-38-00 (Registry Identifier)

B9991046

2021-002457-29 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 8 patient groups

Arm 1

Experimental group

Description:

Avelumab monotherapy as specified by sub-study protocol B9991001C

Treatment:

Drug: Avelumab

Arm 2

Experimental group

Description:

Avelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C

Treatment:

Drug: Avelumab

Drug: PF04518600

Drug: CMP 001

Drug: Utomilumab

Arm 3

Experimental group

Description:

Avelumab in combination with Loratanib as specified by sub-study protocol B9991005C

Treatment:

Drug: Avelumab

Drug: Lorlatanib

Arm 4

Experimental group

Description:

Avelumab monotherapy as specified by sub-study protocol B9991009C

Treatment:

Drug: Avelumab

Arm 5

Experimental group

Description:

Avelumab monotherapy or in combination with Pemetrexed as specified by sub-study protocol B9991023C

Treatment:

Drug: Pemetrexed

Drug: Avelumab

Arm 6

Experimental group

Description:

Avelumab in combination with Talazoparib as specified by sub-study B9991025C.

Treatment:

Drug: Talazoparib

Drug: Avelumab

Arm 7

Experimental group

Description:

Avelumab in combination with Axitinib as specified by sub-study B9991027C.

Treatment:

Drug: Avelumab

Drug: Axitinib

Arm 8

Experimental group

Description:

Avelumab in combination with Talazoparib as specified by sub-study B9991032C.

Treatment:

Drug: Talazoparib

Drug: Avelumab