Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
AVELUMAB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED AVELUMAB CLINICAL STUDIES.
3 other identifiers
interventional
77
19 countries
71
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2021
Longer than P75 for phase_3
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2021
CompletedFirst Posted
Study publicly available on registry
September 28, 2021
CompletedStudy Start
First participant enrolled
September 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
June 22, 2026
June 1, 2026
5.3 years
September 17, 2021
June 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (9)
Arm 1
EXPERIMENTALAvelumab monotherapy as specified by sub-study protocol B9991001C
Arm 2
EXPERIMENTALAvelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C
Arm 3
EXPERIMENTALAvelumab in combination with Loratanib as specified by sub-study protocol B9991005C
Arm 4
EXPERIMENTALAvelumab monotherapy as specified by sub-study protocol B9991009C
Arm 5
EXPERIMENTALAvelumab monotherapy or in combination with Pemetrexed as specified by sub-study protocol B9991023C
Arm 6
EXPERIMENTALAvelumab in combination with Talazoparib as specified by sub-study B9991025C.
Arm 7
EXPERIMENTALAvelumab in combination with Axitinib as specified by sub-study B9991027C.
Arm 8
EXPERIMENTALAvelumab in combination with Talazoparib as specified by sub-study B9991032C.
Arm 9
EXPERIMENTALAvelumab in combination with Axitinib as specified by sub-study protocol B9991003C
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Female participants who are pregnant or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (71)
Highlands Oncology Group, PA
Fayetteville, Arkansas, 72703, United States
Highlands Oncology Group, PA
Rogers, Arkansas, 72758, United States
Highlands Oncology Group, PA
Springdale, Arkansas, 72762, United States
The Regents of the University of California
Los Angeles, California, 900095, United States
UCLA Hematology/Oncology
Los Angeles, California, 90095, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
MSK Basking Ridge
Basking Ridge, New Jersey, 07920, United States
MSK Monmouth
Middletown, New Jersey, 07748, United States
MSK Bergen
Montvale, New Jersey, 07645, United States
MSK Commack
Commack, New York, 11725, United States
MSK Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (IDS Pharmacy)
Long Island City, New York, 11101, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, 10021, United States
Memorial Sloan Kettering Cancer Center 53rd street.
New York, New York, 10022, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
MSK Nassau
Uniondale, New York, 11553, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
The Trustees of the University of Pennsylvania, Clinical Research (OCR)
Philadelphia, Pennsylvania, 19104, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Macquarie University
North Ryde, New South Wales, 2109, Australia
Mater Hospital Sydney
Wollstonecraft, New South Wales, 2060, Australia
Melanoma Institute Australia
Wollstonecraft, New South Wales, 2065, Australia
The Prince Charles Hospital
Chermside, Queensland, 4032, Australia
UZ Gent
Ghent, Oost-vlaanderen, 9000, Belgium
Grand Hôpital de Charleroi
Gilly, 6060, Belgium
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Kingston Health Sciences Centre-Kingston General Hospital Site
Kingston, Ontario, K7L 2V7, Canada
Aalborg Universitetshospital, Syd
Aalborg, North Denmark, 9000, Denmark
Institut de Cancérologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy, Lorraine, 54519, France
Országos Onkológiai Intézet
Budapest, 1122, Hungary
Rabin Medical Center
Petah Tikva, Central District, 4941492, Israel
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Milano, 20133, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
Ancona, 60126, Italy
Oita University Hospital
Yufu, Oita Prefecture, 879-5593, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
Japanese Foundation for Cancer Research
Koto, Tokyo, 135-8550, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460, Mexico
Oaxaca Site Management Organization S.C.
Oaxaca City, 68000, Mexico
Auckland City Hospital
Auckland, 1023, New Zealand
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, 02-507, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, 02-781, Poland
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
Omsk, Omsk Oblast, 644013, Russia
Private Medical Institution "Euromedservice"
Pushkin, Sankt-Peterburg, 196603, Russia
GBUZ SK Pyatigorsk Interdistrict Oncology dispensary
Pyatigorsk, Stavropol Kray, 357502, Russia
Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen
Moscow, 125284, Russia
FBIH "Privolzhskiy Regional Medical Center" of FMBA
Nizhny Novgorod, 603109, Russia
SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan
Ufa, 450054, Russia
Institute for Oncology and Radiology of Serbia
Belgrade, 11000, Serbia
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon], 21565, South Korea
National Cancer Center
Goyang-si, Kyǒnggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 05505, South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035, Spain
Hospital Clínic de Barcelona
Barcelona, Barcelona [barcelona], 08036, Spain
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Hospital Universitario Virgen de Valme
Seville, 41014, Spain
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333, Taiwan
Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN, United Kingdom
Royal Cornwall Hospitals NHS Trust
Truro, TR1 3LJ, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2021
First Posted
September 28, 2021
Study Start
September 29, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
June 22, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
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.