Spots Global Cancer Trial Database for PREventing Second Cancers With DOSTARlimab
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Trial Identification
Brief Title: PREventing Second Cancers With DOSTARlimab
Official Title: A Multicenter, Open-label, Randomized Phase II Study Aiming to Assess the Clinical Impact of Dostarlimab on Occurrence of Second Primary Cancer in Patients With Cured Primary Cancer
Study ID: NCT05855811
Interventions
Study Description
Brief Summary: PredoSTAR is a multicenter, randomized, open-label phase II study proposed to patients at high risk of SPC and in whom the treatment of the FPC does not include immunotherapy. Dostarlimab treatment will be started within 6 months after the completion of treatment for localized FPC (i.e. after the end of last CT, RT cure or surgery with a wash-out period of 4 weeks before to start Dostarlimab). Eligible patients will be randomized (1:1) to receive: * Arm Dostarlimab : 4 intravenous (IV) injections of dostarlimab, Q3W or * Arm No treatment
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Centre François Baclesse, Caen, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Centre Léon Bérard, Lyon, , France
Institut Claudius Regaud, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Contact Details
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