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NCT05059522 Clinical Trial

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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05059522
Other study ID # B9991046
Secondary ID 2021-002457-29
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date September 29, 2021
Est. completion date September 30, 2026

Study information
Verified date April 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 61
Est. completion date September 30, 2026
Est. primary completion date September 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Avelumab
oral
• Lorlatanib
oral
• Talazoparib
oral
• Pemetrexed
IV (intravenous) infusion
• Axitinib
oral
• CMP 001
IT (intratumoral) or SC (subcutaneous)
• Utomilumab
IV infusion
• PF04518600
IV infusion

Locations
Country Name City State
Australia The Prince Charles Hospital Chermside Queensland
Australia Macquarie University North Ryde New South Wales
Australia Mater Hospital Sydney Wollstonecraft New South Wales
Australia Melanoma Institute Australia Wollstonecraft New South Wales
Belgium Grand Hôpital de Charleroi Charleroi Hainaut
Belgium UZ Gent Gent Oost-vlaanderen
Canada Cross Cancer Institute Edmonton Alberta
Canada Kingston Health Sciences Centre-Kingston General Hospital Site Kingston Ontario
Denmark Aalborg Universitetshospital, Syd Aalborg Nordjylland
France Institut de Cancérologie de Lorraine Alexis Vautrin Vandoeuvre-lès-Nancy Lorraine
Hungary Országos Onkológiai Intézet Budapest
Israel Rabin Medical Center Petah Tikva Hamerkaz
Italy Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi Ancona
Italy Fondazione IRCCS Istituto Nazionale dei Tumori Milan Lombardia
Italy Fondazione IRCCS Istituto Nazionale dei Tumori Milan Milano
Italy S.C. Farmacia Ospedaliera Milano Lombardia
Italy AOU Policlinico Umberto I Roma
Italy Istituto Clinico Humanitas Rozzano Milano
Japan National Cancer Center Hospital Chuo-ku Tokyo
Japan National Hospital Organization Kyushu Cancer Center Fukuoka
Japan Japanese Foundation for Cancer Research Koto Tokyo
Japan Oita University Hospital Yufu Oita
Korea, Republic of National Cancer Center Goyang-si Kyonggi-do
Korea, Republic of Gachon University Gil Medical Center Namdong-gu Incheon-gwangyeoksi [incheon]
Korea, Republic of Seoul National University Bundang Hospital Seongnam Kyonggi-do
Korea, Republic of Asan Medical Center Seoul Seoul-teukbyeolsi [seoul]
Korea, Republic of Samsung Medical Center Seoul Seoul-teukbyeolsi [seoul]
Korea, Republic of Seoul National University Hospital Seoul Seoul-teukbyeolsi [seoul]
Mexico Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo LEÓN
Mexico Oaxaca Site Management Organization S.C. Oaxaca
New Zealand Auckland City Hospital Auckland
Poland Centralny Szpital Kliniczny MSWiA w Warszawie Warszawa
Poland Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie Warszawa
Russian Federation Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen Moscow
Russian Federation FBIH "Privolzhskiy Regional Medical Center" of FMBA Nizhniy Novgorod
Russian Federation Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary" Omsk Omskaya Oblast'
Russian Federation Private Medical Institution "Euromedservice" Pushkin Saint - Petersburg
Russian Federation GBUZ SK Pyatigorsk Interdistrict Oncology dispensary Pyatigorsk Stavropol'skiy KRAY
Russian Federation SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan Ufa
Serbia Institute for Oncology and Radiology of Serbia Belgrade
Spain Hospital Clínic de Barcelona Barcelona Barcelona [barcelona]
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Hospital Universitari Vall d'Hebron Barcelona Barcelona [barcelona]
Spain Institut Català d'Oncologia - L'Hospitalet Hospitalet de Llobregat Barcelona
Spain Hospital Universitario Fundación Jiménez Díaz Madrid
Spain Hospital Universitario HM Sanchinarro Madrid
Spain Hospital Universitario Virgen de Valme Sevilla
Taiwan National Cheng Kung University Hospital Tainan
Taiwan National Taiwan University Hospital Taipei
Taiwan Chang Gung Medical Foundation-Linkou Branch Taoyuan
United Kingdom Royal Marsden Hospital (Chelsea) London Kensington AND Chelsea
United Kingdom The Newcastle Upon Tyne Hospitals NHS Foundation Trust Newcastle Upon Tyne
United Kingdom Royal Cornwall Hospitals NHS Trust Truro
United States MSK Basking Ridge Basking Ridge New Jersey
United States MSK Commack Commack New York
United States Highlands Oncology Group, PA Fayetteville Arkansas
United States MSK Westchester Harrison New York
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy Long Island City New York
United States Ronald Reagan UCLA Medical Center - Drug Information Center, Pharmaceutical Services Los Angeles California
United States UCLA Hematology/Oncology Los Angeles California
United States UCLA Hematology/Oncology - Administrative Office Los Angeles California
United States MSK Monmouth Middletown New Jersey
United States MSK Bergen Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). New York New York
United States Memorial Sloan Kettering Cancer Center 53rd street. New York New York
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Highlands Oncology Group, PA Rogers Arkansas
United States Fred Hutchinson Cancer Center Seattle Washington
United States Highlands Oncology Group, PA Springdale Arkansas
United States Moffitt Cancer Center Tampa Florida
United States MSK Nassau Uniondale New York

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  France,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  New Zealand,  Poland,  Russian Federation,  Serbia,  Spain,  Taiwan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events leading to permanent discontinuation of study intervention Baseline up to approximately 5 years
Primary Number serious adverse events reported for all participants Baseline up to approximately 5 years
See also
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Completed NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer Phase 2
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Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT03146663 - NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer Phase 2
Active, not recruiting NCT05082025 - Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations Phase 2
Recruiting NCT03010124 - Prognostic and Predictive Biomarkers in Ovarian Cancers N/A

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