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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05059522
Recruitment Status : Recruiting
First Posted : September 28, 2021
Last Update Posted : May 25, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Malignancies NSCLC Ovarian Cancer Urothelial Cancer Solid Tumors Drug: Avelumab Drug: Lorlatanib Drug: Talazoparib Drug: Pemetrexed Drug: Axitinib Drug: CMP 001 Drug: Utomilumab Drug: PF04518600 Phase 3

Detailed 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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 262 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Avelumab Master Protocol: An Open-label Continuation Study for Participants Continuing From Pfizer-sponsored Avelumab Clinical Studies.
Actual Study Start Date : September 29, 2021
Estimated Primary Completion Date : December 22, 2025
Estimated Study Completion Date : December 22, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Avelumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
Avelumab monotherapy as specified by sub-study protocol B9991001C
 Drug: Avelumab
oral
Experimental: Arm 2
Avelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C
 Drug: Avelumab
oral

Drug: CMP 001
IT (intratumoral) or SC (subcutaneous)

Drug: Utomilumab
IV infusion

Drug: PF04518600
IV infusion
Experimental: Arm 3
Avelumab in combination with Loratanib as specified by sub-study protocol B9991005C
 Drug: Avelumab
oral

Drug: Lorlatanib
oral
Experimental: Arm 4
Avelumab monotherapy as specified by sub-study protocol B9991009C
 Drug: Avelumab
oral
Experimental: Arm 5
Avelumab monotherapy or in combination with Pemetrexed as specified by sub-study protocol B9991023C
 Drug: Avelumab
oral

Drug: Pemetrexed
IV (intravenous) infusion
Experimental: Arm 6
Avelumab in combination with Talazoparib as specified by sub-study B9991025C.
 Drug: Avelumab
oral

Drug: Talazoparib
oral
Experimental: Arm 7
Avelumab in combination with Axitinib as specified by sub-study B9991027C.
 Drug: Avelumab
oral

Drug: Axitinib
oral
Experimental: Arm 8
Avelumab in combination with Talazoparib as specified by sub-study B9991032C.
 Drug: Avelumab
oral

Drug: Talazoparib
oral


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events leading to permanent discontinuation of study intervention [ Time Frame: Baseline up to approximately 5 years ]
  2. Number serious adverse events reported for all participants [ Time Frame: Baseline up to approximately 5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05059522


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05059522    
Other Study ID Numbers: B9991046
2021-002457-29 ( EudraCT Number )
First Posted: September 28, 2021    Key Record Dates
Last Update Posted: May 25, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
BRCA Mutant Tumors
ATM Mutant Tumors
Additional relevant MeSH terms:
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Pemetrexed
Avelumab
Axitinib
Talazoparib
Antineoplastic Agents
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Immunological
Protein Kinase Inhibitors
Poly(ADP-ribose) Polymerase Inhibitors