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

Study Overview
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Brief Summary
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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
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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

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

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

Intervention / Treatment
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* Drug: Avelumab
* Drug: Lorlatanib
* Drug: Talazoparib
* Drug: Pemetrexed
* Drug: Axitinib
* Drug: CMP 001
* Drug: Utomilumab
* Drug: PF04518600


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Participants must agree to follow the reproductive criteria. Participants must be willing and able to comply with all scheduled visits, treatment plan, and other study procedures. Exclusion Criteria: Female participants who are pregnant or breastfeeding. Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Avelumab monotherapy as specified by sub-study protocol B9991001C | Drug: Avelumab<br>* oral<br>|
| Experimental: Arm 2<br>Avelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C | Drug: Avelumab<br>* oral<br>Drug: CMP 001<br>* IT (intratumoral) or SC (subcutaneous)<br>Drug: Utomilumab<br>* IV infusion<br>Drug: PF04518600<br>* IV infusion<br>|
| Experimental: Arm 3<br>Avelumab in combination with Loratanib as specified by sub-study protocol B9991005C | Drug: Avelumab<br>* oral<br>Drug: Lorlatanib<br>* oral<br>|
| Experimental: Arm 4<br>Avelumab monotherapy as specified by sub-study protocol B9991009C | Drug: Avelumab<br>* oral<br>|
| Experimental: Arm 5<br>Avelumab monotherapy or in combination with Pemetrexed as specified by sub-study protocol B9991023C | Drug: Avelumab<br>* oral<br>Drug: Pemetrexed<br>* IV (intravenous) infusion<br>|
| Experimental: Arm 6<br>Avelumab in combination with Talazoparib as specified by sub-study B9991025C. | Drug: Avelumab<br>* oral<br>Drug: Talazoparib<br>* oral<br>|
| Experimental: Arm 7<br>Avelumab in combination with Axitinib as specified by sub-study B9991027C. | Drug: Avelumab<br>* oral<br>Drug: Axitinib<br>* oral<br>|
| Experimental: Arm 8<br>Avelumab in combination with Talazoparib as specified by sub-study B9991032C. | Drug: Avelumab<br>* oral<br>Drug: Talazoparib<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events leading to permanent discontinuation of study intervention |  | Baseline up to approximately 5 years | 
| Number serious adverse events reported for all participants |  | Baseline up to approximately 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BRCA Mutant Tumors, ATM Mutant Tumors