drugset / Trial / NCT04741438

Efficacy of the Combination of Nivolumab and Ipilimumab as a Treatment in Patients With Sarcoma of Rare Subtype

NCT04741438

Phase 3 Unknown 96 enrolled Centre Leon Berard
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized open label study, with 2 arms treatments conducted in patients with metastatic or unresectable advanced sarcoma of rare subtype; previously treated by anthracycline-based regimen except for whom standard therapy does not exist or is not considered appropriate by the Investigator. In the experimental arm, patients will receive the combination of Nivolumab + Ipilimumab for a maximum of 24 months, whereas in the control arm, patients will receive Pazopanib alone. The purpose of the study is to know if the combination of nivolumab + ipilimumab can be more efficient than Pazopanib in terms of Progression-Free Survival.

Timeline

Start
2021-03-30
Primary completion
2025-02
Completion
2025-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 1 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 480 mg Intravenous
Comparator Pazopanib Small molecule 800 mg Oral

Indications