PREventing Second Cancers With DOSTARlimab

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

NCT Number	NCT05855811
Lead Sponsor	Centre Leon Berard Collaborators: GlaxoSmithKline
Conditions	Recurrent Cancer, Primary Cancer, Second Cancer
Enrollment	400 participants
Start Date	2023-07-26
Primary Completion	2028-07-26 (estimated)
Study Completion	2029-03-26 (estimated)
Updated on ClinicalTrials.gov	2024-07-15