NCT05855811

PREventing Second Cancers With DOSTARlimab

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Recurrent Cancer
• Primary Cancer
• Second Cancer

Interventions

Type	Name	Description
DRUG	Dostarlimab	Dostarlimab should initiated within 6 months after the end of treatment for FPC.

Timeline

• Start date: 2023-07-26
• Primary completion: 2028-07-26
• Completion: 2029-03-26
• First posted: 2023-05-11
• Last updated: 2024-07-15

Locations

5 sites across 1 country: France