Clinical Trial 18928

Cancer Type: Thoracic
Interventions:Alimta (Pemetrexed); BMS-936558 (Nivolumab); Ipilimumab; Nivolumab; Paraplatin (carboplatin); Pemetrexed; Yervoy (Ipilimumab); carboplatin; cisplatin

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Scott Antonia

Overview

Study Title

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

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.

Objective

Objectives: Primary Objectives: To compare progression free survival (PFS) as determined by Blinded Independent Committee Review and overall survival (OS) of nivolumab combined with ipilimumab to pemetrexed plus cisplatin or carboplatin regimen as first line treatment in patients with unresectable pleural mesothelioma. Secondary Objectives: To compare the objective response rate (ORR) as determined by BICR, of nivolumab combined with ipilimumab to pemetrexed plus cisplatin or carboplatin as first line treatment in patients with unresectable pleural mesothelioma. To compare the Disease Control Rate (DCR) as determined by BICR, of nivolumab combined with ipilimumab to pemetrexed plus cisplatin or carboplatin as first line treatment in patients with unresectable pleural mesothelioma. To evaluate whether PD-L1 expression is a predictive biomarker for ORR, PFS, and OS. Exploratory Objectives: To assess safety and tolerability of nivolumab combination with ipilimumab, and pemetrexed plus cisplatin or carboplatin as first line treatment in patients with unresectable pleural mesothelioma. To characterize pharmacokinetics of nivolumab in combination with ipilimumab as first line in patients with unresectable malignant pleural mesothelioma (MPM). To characterize the immunogenicity of Nivolumab in combination with ipilimumab as first line in patients with unresectable MPM. To assess the participant's overall health status and health utility using the 3-level version of the EQ-5D (EQ-5D-3L) visual analog scale (VAS) and utility index, respectively. To assess the participant's cancer-related symptoms and quality of life using the mesothelioma adaptation of the Lung Cancer Symptom Scale (LCSS-Meso).

Inclusion Criteria

  • Males and Females at least 18 years of age
  • Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery
  • ECOG Performance status of 0 or 1
  • Available tumor sample for testing
  • Acceptable blood work

  • Exclusion Criteria

  • Primitive peritoneal, pericardial and tunica vaginalis testis mesotheliomas
  • Prior chemotherapy for pleural mesothelioma
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 oranti-CTLA-4 antibody
  • History of other malignancy unless the subject has been disease-free for at least 3 years
  • Active, untreated central nervous system (CNS) metastasis
  • Other protocol defined inclusion/exclusion criteria could apply