Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
- Conditions
- Advanced MalignanciesNSCLCOvarian CancerUrothelial CancerSolid Tumors
- Interventions
- Registration Number
- NCT05059522
- Lead Sponsor
- Pfizer
- 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.
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 67
- 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.
- Female participants who are pregnant or breastfeeding.
- Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 CMP 001 Avelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C Arm 1 Avelumab Avelumab monotherapy as specified by sub-study protocol B9991001C Arm 3 Lorlatanib Avelumab in combination with Loratanib as specified by sub-study protocol B9991005C Arm 5 Avelumab Avelumab monotherapy or in combination with Pemetrexed as specified by sub-study protocol B9991023C Arm 2 PF04518600 Avelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C Arm 4 Avelumab Avelumab monotherapy as specified by sub-study protocol B9991009C Arm 8 Talazoparib Avelumab in combination with Talazoparib as specified by sub-study B9991032C. Arm 2 Avelumab Avelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C Arm 2 Utomilumab Avelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C Arm 3 Avelumab Avelumab in combination with Loratanib as specified by sub-study protocol B9991005C Arm 6 Talazoparib Avelumab in combination with Talazoparib as specified by sub-study B9991025C. Arm 5 Pemetrexed Avelumab monotherapy or in combination with Pemetrexed as specified by sub-study protocol B9991023C Arm 6 Avelumab Avelumab in combination with Talazoparib as specified by sub-study B9991025C. Arm 7 Avelumab Avelumab in combination with Axitinib as specified by sub-study B9991027C. Arm 7 Axitinib Avelumab in combination with Axitinib as specified by sub-study B9991027C. Arm 8 Avelumab Avelumab in combination with Talazoparib as specified by sub-study B9991032C.
- Primary Outcome Measures
Name Time Method Number serious adverse events reported for all participants Baseline up to approximately 5 years Number of participants with adverse events leading to permanent discontinuation of study intervention Baseline up to approximately 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (69)
Highlands Oncology Group, PA
🇺🇸Springdale, Arkansas, United States
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
🇷🇺Omsk, Omskaya Oblast', Russian Federation
MSK Monmouth
🇺🇸Middletown, New Jersey, United States
Japanese Foundation for Cancer Research
🇯🇵Koto, Tokyo, Japan
Institut Català d'Oncologia - L'Hospitalet
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Országos Onkológiai Intézet
🇭🇺Budapest, Hungary
Grand Hôpital de Charleroi
🇧🇪Charleroi, Hainaut, Belgium
UZ Gent
🇧🇪Gent, Oost-vlaanderen, Belgium
Oita University Hospital
🇯🇵Yufu, Ōita, Japan
Rabin Medical Center
🇮🇱Petah Tikva, Hamerkaz, Israel
Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen
🇷🇺Moscow, Russian Federation
Oaxaca Site Management Organization S.C.
🇲🇽Oaxaca, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
🇲🇽Monterrey, Nuevo LEÓN, Mexico
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
National Cancer Center
🇰🇷Goyang-si, Kyǒnggi-do, Korea, Republic of
Centralny Szpital Kliniczny MSWiA w Warszawie
🇵🇱Warszawa, Poland
SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan
🇷🇺Ufa, Russian Federation
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
🇵🇱Warszawa, Poland
Private Medical Institution "Euromedservice"
🇷🇺Pushkin, Saint - Petersburg, Russian Federation
FBIH "Privolzhskiy Regional Medical Center" of FMBA
🇷🇺Nizhniy Novgorod, Russian Federation
UCLA Hematology/Oncology
🇺🇸Los Angeles, California, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
MSK Basking Ridge
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
MSK Bergen
🇺🇸Montvale, New Jersey, United States
Mater Hospital Sydney
🇦🇺Wollstonecraft, New South Wales, Australia
Kingston Health Sciences Centre-Kingston General Hospital Site
🇨🇦Kingston, Ontario, Canada
UCLA Hematology/Oncology - Administrative Office
🇺🇸Los Angeles, California, United States
Memorial Sloan Kettering Cancer Center 53rd street.
🇺🇸New York, New York, United States
MSK Commack
🇺🇸Commack, New York, United States
Ronald Reagan UCLA Medical Center - Drug Information Center, Pharmaceutical Services
🇺🇸Los Angeles, California, United States
Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
MSK Westchester
🇺🇸Harrison, New York, United States
Macquarie University
🇦🇺North Ryde, New South Wales, Australia
Seoul National University Bundang Hospital
🇰🇷Seongnam, Kyǒnggi-do, Korea, Republic of
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle Upon Tyne, United Kingdom
Gachon University Gil Medical Center
🇰🇷Namdong-gu, Incheon-gwangyeoksi [incheon], Korea, Republic of
The Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Samsung Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Hospital Universitario Virgen de Valme
🇪🇸Sevilla, Spain
Hospital Universitario HM Sanchinarro
🇪🇸Madrid, Spain
Asan Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka, Japan
Royal Marsden Hospital (Chelsea)
🇬🇧London, Kensington AND Chelsea, United Kingdom
Seoul National University Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Hospital Clínic de Barcelona
🇪🇸Barcelona, Barcelona [barcelona], Spain
Chang Gung Medical Foundation-Linkou Branch
🇨🇳Taoyuan, Taiwan
Hospital Universitario Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Auckland City Hospital
🇳🇿Auckland, New Zealand
Aalborg Universitetshospital, Syd
🇩🇰Aalborg, Nordjylland, Denmark
S.C. Farmacia Ospedaliera
🇮🇹Milano, Lombardia, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milan, Milano, Italy
AOU Policlinico Umberto I
🇮🇹Roma, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
🇮🇹Ancona, Italy
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
MSK Nassau
🇺🇸Uniondale, New York, United States
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
🇺🇸Long Island City, New York, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
🇺🇸New York, New York, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Institut de Cancérologie de Lorraine Alexis Vautrin
🇫🇷Vandoeuvre-lès-Nancy, Lorraine, France
Institute for Oncology and Radiology of Serbia
🇷🇸Belgrade, Serbia
GBUZ SK Pyatigorsk Interdistrict Oncology dispensary
🇷🇺Pyatigorsk, Stavropol'skiy KRAY, Russian Federation
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Melanoma Institute Australia
🇦🇺Wollstonecraft, New South Wales, Australia
Royal Cornwall Hospitals NHS Trust
🇬🇧Truro, United Kingdom