PREventing Second Cancers With DOSTARlimab

Sponsor
Centre Leon Berard
Study ID
NCT05855811
Phase
PHASE2
Status
Recruiting
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Conditions

  • Primary Cancer
  • Recurrent Cancer
  • Second Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dostarlimab — DRUG
    Dostarlimab should initiated within 6 months after the end of treatment for FPC.

Study Details

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

Key Dates

Start date
Jul 26, 2023
Status verified
Jul 2024
Primary completion
Jul 26, 2028
Completion
Mar 26, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Dostarlimab
    4 intravenous injections maximum of dostarlimab, 500mg, every 3 weeks
  • No Intervention: No treatment

Primary Outcome Measure

Incidence of Second Primary Cancer (SPC) in patients who have completed curative treatment for a First Primary Cancer (FPC). [ Time Frame: Up to 3 years ]

Central Contacts

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