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

Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Study ID
NCT02716272
Phase
PHASE2
Status
Completed

Conditions

  • Mesothelioma

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab administered IV over 60 minutes at 3mg/kg every 2 weeks
  • Nivolumab + Ipilimumab — DRUG
    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

Study Details

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.

Key Dates

Start date
Mar 24, 2016
Status verified
Feb 2021
Primary completion
Feb 28, 2018
Completion
Jun 22, 2019

Study Design

Enrollment
125 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MONOTHERAPY ARM
    Nivolumab administered IV over 60 minutes at 3mg/kg every 2 weeks
  • Experimental: COMBINATION ARM
    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

Primary Outcome Measure

Disease Control rate assessed by CT scan [ Time Frame: 3-months ]

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