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

NCT ID: NCT05059522

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-29

Study Completion Date

2026-09-30

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 B9991003 - NCT02684006 B9991004 - NCT02554812 B9991005 - NCT02584634 B9991009 - NCT02580058 B9991023 - NCT03317496 B9991025 - NCT03330405 B9991027 - NCT03472560 B9991032 - NCT03565991

Conditions

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Advanced Malignancies NSCLC Ovarian Cancer Urothelial Cancer Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Avelumab monotherapy as specified by sub-study protocol B9991001C

Group Type EXPERIMENTAL

Avelumab

Intervention Type DRUG

oral

Arm 2

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

Group Type EXPERIMENTAL

Avelumab

Intervention Type DRUG

oral

CMP 001

Intervention Type DRUG

IT (intratumoral) or SC (subcutaneous)

Utomilumab

Intervention Type DRUG

IV infusion

PF04518600

Intervention Type DRUG

IV infusion

Arm 3

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

Group Type EXPERIMENTAL

Avelumab

Intervention Type DRUG

oral

Lorlatanib

Intervention Type DRUG

oral

Arm 4

Avelumab monotherapy as specified by sub-study protocol B9991009C

Group Type EXPERIMENTAL

Avelumab

Intervention Type DRUG

oral

Arm 5

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

Group Type EXPERIMENTAL

Avelumab

Intervention Type DRUG

oral

Pemetrexed

Intervention Type DRUG

IV (intravenous) infusion

Arm 6

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

Group Type EXPERIMENTAL

Avelumab

Intervention Type DRUG

oral

Talazoparib

Intervention Type DRUG

oral

Arm 7

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

Group Type EXPERIMENTAL

Avelumab

Intervention Type DRUG

oral

Axitinib

Intervention Type DRUG

oral

Arm 8

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

Group Type EXPERIMENTAL

Avelumab

Intervention Type DRUG

oral

Talazoparib

Intervention Type DRUG

oral

Arm 9

Avelumab in combination with Axitinib as specified by sub-study protocol B9991003C

Group Type EXPERIMENTAL

Avelumab

Intervention Type DRUG

oral

Axitinib

Intervention Type DRUG

oral

Interventions

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Avelumab

oral

Intervention Type DRUG

Lorlatanib

oral

Intervention Type DRUG

Talazoparib

oral

Intervention Type DRUG

Pemetrexed

IV (intravenous) infusion

Intervention Type DRUG

Axitinib

oral

Intervention Type DRUG

CMP 001

IT (intratumoral) or SC (subcutaneous)

Intervention Type DRUG

Utomilumab

IV infusion

Intervention Type DRUG

PF04518600

IV infusion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Highlands Oncology Group, PA

Fayetteville, Arkansas, United States

Site Status

Highlands Oncology Group, PA

Rogers, Arkansas, United States

Site Status

Highlands Oncology Group, PA

Springdale, Arkansas, United States

Site Status

UCLA Hematology/Oncology

Los Angeles, California, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

MSK Basking Ridge

Basking Ridge, New Jersey, United States

Site Status

MSK Monmouth

Middletown, New Jersey, United States

Site Status

MSK Bergen

Montvale, New Jersey, United States

Site Status

MSK Commack

Commack, New York, United States

Site Status

MSK Westchester

Harrison, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center 53rd street.

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

MSK Nassau

Uniondale, New York, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Site Status

Macquarie University

North Ryde, New South Wales, Australia

Site Status

Mater Hospital Sydney

Wollstonecraft, New South Wales, Australia

Site Status

Melanoma Institute Australia

Wollstonecraft, New South Wales, Australia

Site Status

The Prince Charles Hospital

Chermside, Queensland, Australia

Site Status

Grand Hôpital de Charleroi

Gilly, Hainaut, Belgium

Site Status

UZ Gent

Ghent, Oost-vlaanderen, Belgium

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

Kingston Health Sciences Centre-Kingston General Hospital Site

Kingston, Ontario, Canada

Site Status

Aalborg Universitetshospital, Syd

Aalborg, North Denmark, Denmark

Site Status

Institut de Cancérologie de Lorraine Alexis Vautrin

Vandœuvre-lès-Nancy, Lorraine, France

Site Status

Országos Onkológiai Intézet

Budapest, , Hungary

Site Status

Rabin Medical Center

Petah Tikva, Central District, Israel

Site Status

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

Site Status

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Milano, Italy

Site Status

IRCCS Istituto Clinico Humanitas

Rozzano, Milano, Italy

Site Status

Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi

Ancona, , Italy

Site Status

Oita University Hospital

Yufu, Oita Prefecture, Japan

Site Status

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Site Status

Japanese Foundation for Cancer Research

Koto, Tokyo, Japan

Site Status

National Hospital Organization Kyushu Cancer Center

Fukuoka, , Japan

Site Status

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico

Site Status

Oaxaca Site Management Organization S.C.

Oaxaca City, , Mexico

Site Status

Auckland City Hospital

Auckland, , New Zealand

Site Status

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, , Poland

Site Status

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie

Warsaw, , Poland

Site Status

Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"

Omsk, Omsk Oblast, Russia

Site Status

Private Medical Institution "Euromedservice"

Pushkin, Sankt-Peterburg, Russia

Site Status

GBUZ SK Pyatigorsk Interdistrict Oncology dispensary

Pyatigorsk, Stavropol Kray, Russia

Site Status

Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen

Moscow, , Russia

Site Status

FBIH "Privolzhskiy Regional Medical Center" of FMBA

Nizhny Novgorod, , Russia

Site Status

SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan

Ufa, , Russia

Site Status

Institute for Oncology and Radiology of Serbia

Belgrade, , Serbia

Site Status

Gachon University Gil Medical Center

Namdong-gu, Incheon-gwangyeoksi [incheon], South Korea

Site Status

National Cancer Center

Goyang-si, Kyǒnggi-do, South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea

Site Status

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Site Status

Asan Medical Center

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Site Status

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona], Spain

Site Status

Hospital Clínic de Barcelona

Barcelona, Barcelona [barcelona], Spain

Site Status

Institut Català d'Oncologia - L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Site Status

Hospital Universitario HM Sanchinarro

Madrid, , Spain

Site Status

Hospital Universitario Virgen de Valme

Seville, , Spain

Site Status

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, , Taiwan

Site Status

Royal Marsden Hospital (Chelsea)

London, Kensington and Chelsea, United Kingdom

Site Status

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, , United Kingdom

Site Status

Royal Cornwall Hospitals NHS Trust

Truro, , United Kingdom

Site Status

Countries

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United States Australia Belgium Canada Denmark France Hungary Israel Italy Japan Mexico New Zealand Poland Russia Serbia South Korea Spain Taiwan United Kingdom

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B9991046

To obtain contact information for a study center near you, click here.

Other Identifiers

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2023-509466-38-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

B9991046

Identifier Type: -

Identifier Source: org_study_id

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