drugset / Trial / NCT02716272

Nivolumab Monotherapy or Nivolumab Plus Ipilimumab, for Unresectable Malignant Pleural Mesothelioma (MPM) Patients

NCT02716272 ↗

Phase 2 Completed 125 enrolled French Cooperative Thoracic Intergroup
RandomizedParallel-groupOpen-labelTreatment

Summary

The sponsor raise the hypothesis that inhibition of immune PD-1+/- CTLA-4 check-point(s) would delay tumor progression in patients with unresectable MPM, experiencing disease progression after one or two lines of chemotherapy including at least first-line with pemetrexed and platinum, without altering significantly the quality of life of patients.

Timeline

Start
2016-03-24
Primary completion
2018-02
Completion
2019-06-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 1 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 3 mg/kg Intravenous

Indications