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

April 9, 2026 updated by: Pfizer

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • North Ryde, New South Wales, Australia, 2109
        • Macquarie University
      • Wollstonecraft, New South Wales, Australia, 2065
        • Melanoma Institute Australia
      • Wollstonecraft, New South Wales, Australia, 2060
        • Mater Hospital Sydney
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • The Prince Charles Hospital
  • Belgium
      • Gilly, Belgium, 6060
        • Grand Hopital de Charleroi
    • Oost-vlaanderen
      • Ghent, Oost-vlaanderen, Belgium, 9000
        • UZ Gent
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre-Kingston General Hospital Site
  • Denmark
    • North Denmark
      • Aalborg, North Denmark, Denmark, 9000
        • Aalborg Universitetshospital, Syd
  • France
    • Lorraine
      • Vandœuvre-lès-Nancy, Lorraine, France, 54519
        • Institut de Cancérologie de Lorraine Alexis Vautrin
  • Hungary
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet
  • Israel
    • Central District
      • Petah Tikva, Central District, Israel, 4941492
        • Rabin Medical Center
  • Italy
      • Ancona, Italy, 60126
        • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
    • Milano
      • Milan, Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Rozzano, Milano, Italy, 20089
        • IRCCS Istituto Clinico Humanitas
  • Japan
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
    • Oita Prefecture
      • Yufu, Oita Prefecture, Japan, 879-5593
        • Oita University Hospital
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Koto, Tokyo, Japan, 135-8550
        • Japanese Foundation for Cancer Research
  • Mexico
      • Oaxaca City, Mexico, 68000
        • Oaxaca Site Management Organization S.C.
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
  • Poland
      • Warsaw, Poland, 02-507
        • Centralny Szpital Kliniczny MSWiA w Warszawie
      • Warsaw, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
  • Russia
      • Moscow, Russia, 125284
        • Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen
      • Nizhny Novgorod, Russia, 603109
        • FBIH "Privolzhskiy Regional Medical Center" of FMBA
      • Ufa, Russia, 450054
        • SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan
    • Omsk Oblast
      • Omsk, Omsk Oblast, Russia, 644013
        • Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
    • Sankt-Peterburg
      • Pushkin, Sankt-Peterburg, Russia, 196603
        • Private Medical Institution "Euromedservice"
    • Stavropol Kray
      • Pyatigorsk, Stavropol Kray, Russia, 357502
        • GBUZ SK Pyatigorsk Interdistrict Oncology dispensary
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute for Oncology and Radiology of Serbia
  • South Korea
    • Incheon-gwangyeoksi [incheon]
      • Namdong-gu, Incheon-gwangyeoksi [incheon], South Korea, 21565
        • Gachon University Gil Medical Center
    • Kyǒnggi-do
      • Goyang-si, Kyǒnggi-do, South Korea, 10408
        • National Cancer Center
      • Seongnam, Kyǒnggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
        • Seoul National University Hospital
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 05505
        • Asan Medical Center
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06351
        • Samsung Medical Center
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro
      • Seville, Spain, 41014
        • Hospital Universitario Virgen de Valme
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Institut Catala d'Oncologia - L'Hospitalet
    • Barcelona [barcelona]
      • Barcelona, Barcelona [barcelona], Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Barcelona [barcelona], Spain, 08036
        • Hospital Clinic De Barcelona
  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taoyuan District, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou Branch
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden NHS Foundation Trust
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
      • Truro, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospitals NHS Trust
  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group, PA
      • Rogers, Arkansas, United States, 72758
        • Highlands Oncology Group, PA
      • Springdale, Arkansas, United States, 72762
        • Highlands Oncology Group, PA
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Hematology/Oncology
      • Los Angeles, California, United States, 900095
        • The Regents of the University of California
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • MSK Basking Ridge
      • Middletown, New Jersey, United States, 07748
        • MSK Monmouth
      • Montvale, New Jersey, United States, 07645
        • MSK Bergen
    • New York
      • Commack, New York, United States, 11725
        • MSK Commack
      • Harrison, New York, United States, 10604
        • MSK Westchester
      • Long Island City, New York, United States, 11101
        • Memorial Sloan Kettering Cancer Center (IDS Pharmacy)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
      • New York, New York, United States, 10022
        • Memorial Sloan Kettering Cancer Center 53rd street.
      • Uniondale, New York, United States, 11553
        • MSK Nassau
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Trustees of the University of Pennsylvania, Clinical Research (OCR)
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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
Experimental: Arm 9
Avelumab in combination with Axitinib as specified by sub-study protocol B9991003C
Drug: Avelumab
oral
Drug: Axitinib
oral

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2021

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

September 17, 2021

First Submitted That Met QC Criteria

September 17, 2021

First Posted (Actual)

September 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B9991046
  • 2023-509466-38-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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