NCT02716272

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

A Randomized Phase II Study Evaluating Efficacy and Safety of 2nd or 3rd Line Treatment by Nivolumab Monotherapy or Nivolumab Plus Ipilimumab, for Unresectable Malignant Pleural Mesothelioma (MPM) Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Intergroupe Francophone de Cancerologie Thoracique · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mesothelioma

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab administered IV over 60 minutes at 3mg/kg every 2 weeks
DRUG	Nivolumab + Ipilimumab	Nivolumab administered IV over 60 minutes at 3mg/kg every 2 weeks, combined with Ipilimumab administered IV over 90 minutes at 1mg/Kg every 6 weeks

Timeline

• Start date: 2016-03-24
• Primary completion: 2018-02-01
• Completion: 2019-06-22
• First posted: 2016-03-23
• Last updated: 2021-02-10

Locations

22 sites across 1 country: France