Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
Phase 3 – large-scale trial before approval
Conditions:
Advanced Malignancies
NSCLC
Ovarian Cancer
Urothelial Cancer
Solid Tumors
Sponsor: Pfizer
trial.available_in:
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Overview
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 B9991003 - NCT02684006 B9991004 - NCT02554812 B9991005 - NCT02584634 B9991009 - NCT02580058 B9991023 - NCT03317496 B9991025 - NCT03330405 B9991027 - NCT03472560 B9991032 - NCT03565991
Who can participate
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.
Locations
19
Australia (1)
Macquarie University
North Ryde , New South Wales
Belgium (1)
UZ Gent
Ghent , Oost-vlaanderen
Canada (1)
Cross Cancer Institute
Edmonton , Alberta
Denmark (1)
Aalborg Universitetshospital, Syd
Aalborg , North Denmark
France (1)
Institut de Cancérologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy , Lorraine
Hungary (1)
Országos Onkológiai Intézet
Budapest
Israel (1)
Rabin Medical Center
Petah Tikva , Central District
Italy (1)
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan , Lombardy
Japan (1)
Oita University Hospital
Yufu , Oita Prefecture
Mexico (1)
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey , Nuevo León
New Zealand (1)
Auckland City Hospital
Auckland
Poland (1)
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw
Russia (1)
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
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