clinical trial · NCT05855811
PREventing Second Cancers With DOSTARlimab
Centre Leon Berard·phase2·recruiting·n = 400
Recurrent CancerPrimary CancerSecond CancerDostarlimab
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
started
Jul 26, 2023
primary completion
Jul 26, 2028
completion
Mar 26, 2029
last updated
Jul 15, 2024
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol