CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 605 enrolled
Drug / intervention
Nivolumab +4 morebiological
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery
  • ✓ECOG Performance status of 0 or 1
  • ✓Available tumor sample for testing
  • ✓Age at least 18 years
Key exclusion· 5
  • ✕Prior chemotherapy for pleural mesothelioma
  • ✕Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody
  • ✕Primitive peritoneal, pericardial, and tunica vaginalis testis mesotheliomas
  • ✕History of other malignancy unless disease-free for at least 3 years

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02899299
NCT02899299Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Open Label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma

Bristol-Myers Squibb·interventional·Posted Sep 14, 2016·Updated May 21, 2024

In Brief

A Phase 3 clinical trial evaluating Nivolumab, Ipilimumab, and 3 other interventions for Mesothelioma. Completed, enrolled 605 participants across 109 sites in 21 countries.

Detailed Summary

The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMesothelioma
CountriesAustralia, Belgium, Brazil, Chile, China, Colombia, France, Germany, Greece, Italy, Japan, Mexico, Netherlands, Poland, Romania, Russia, South Africa, Switzerland, Turkey (Türkiye), United Kingdom, United States
CollaboratorsOno Pharmaceutical Co., Ltd.

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 14, 2016
Enrollment StartNov 29, 2016
Primary CompletionMar 25, 2020
Study CompletionApr 28, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 9.8 years ago

Interventions

Nivolumabbiological

Ipilimumabbiological

Pemetrexeddrug

Cisplatindrug

Carboplatindrug