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PREventing Second Cancers With DOSTARlimab

NCT05855811 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-07-15

No results posted yet for this study

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

DRUG

Dostarlimab

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-26
Primary Completion
2028-07-26
Completion
2029-03-26

Countries

  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05855811 on ClinicalTrials.gov