Clinical trial NCT05059522: Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
Official title: Avelumab Master Protocol: An Open-label Continuation Study for Participants Continuing From Pfizer-sponsored Avelumab Clinical Studies.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Advanced Malignancies
NSCLC
Ovarian Cancer
Urothelial Cancer
Solid Tumors
Keywords: BRCA Mutant Tumors
ATM Mutant Tumors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-09-28
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with adverse events leading to permanent discontinuation of study intervention
timeFrame: Baseline up to approximately 5 years
measure: Number serious adverse events reported for all participants
timeFrame: Baseline up to approximately 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Highlands Oncology Group, PA
state: Arkansas
city: Rogers
country: United States
facility: Highlands Oncology Group, PA
state: Arkansas
city: Springdale
country: United States
facility: Highlands Oncology Group, PA
state: Arkansas
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Administrative Office
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center - Drug Information Center, Pharmaceutical Services
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Basking Ridge
country: United States
facility: MSK Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: MSK Monmouth
state: New Jersey
city: Montvale
country: United States
facility: MSK Bergen
state: New Jersey
city: Commack
country: United States
facility: MSK Commack
state: New York
city: Harrison
country: United States
facility: MSK Westchester
state: New York
city: Long Island City
country: United States
facility: Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center 53rd street.
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: MSK Nassau
state: New York
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: North Ryde
country: Australia
facility: Macquarie University
state: New South Wales
city: Wollstonecraft
country: Australia
facility: Mater Hospital Sydney
state: New South Wales
city: Wollstonecraft
country: Australia
facility: Melanoma Institute Australia
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
state: Hainaut
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-vlaanderen
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre-Kingston General Hospital Site
state: Ontario
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital, Syd
state: Nordjylland
city: Vandoeuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine Alexis Vautrin
state: Lorraine
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
state: Hamerkaz
city: Milano
country: Italy
facility: S.C. Farmacia Ospedaliera
state: Lombardia
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Lombardia
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Milano
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto
country: Japan
facility: Japanese Foundation for Cancer Research
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Yufu
country: Japan
facility: Oita University Hospital
state: Ōita
city: Namdong-gu
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Incheon-gwangyeoksi [incheon]
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Kyǒnggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyǒnggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [seoul]
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo LEÓN
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization S.C.
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA w Warszawie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
city: Omsk
country: Russian Federation
facility: Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
state: Omskaya Oblast'
city: Pushkin
country: Russian Federation
facility: Private Medical Institution "Euromedservice"
state: Saint - Petersburg
city: Pyatigorsk
country: Russian Federation
facility: GBUZ SK Pyatigorsk Interdistrict Oncology dispensary
state: Stavropol'skiy KRAY
city: Moscow
country: Russian Federation
facility: Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen
city: Nizhniy Novgorod
country: Russian Federation
facility: FBIH "Privolzhskiy Regional Medical Center" of FMBA
city: Ufa
country: Russian Federation
facility: SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan
city: Belgrade
country: Serbia
facility: Institute for Oncology and Radiology of Serbia
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [barcelona]
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Barcelona [barcelona]
city: Hospitalet de Llobregat
country: Spain
facility: Institut Català d'Oncologia - L'Hospitalet
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
city: London
country: United Kingdom
facility: Royal Marsden Hospital (Chelsea)
state: Kensington AND Chelsea
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: