A Phase II, Randomized, Open-label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First-line Therapy for Unresectable Pleural Mesothelioma in Chinese Participants

Bristol-Myers Squibb26 sites in 1 country102 target enrollmentJanuary 25, 2022

ConditionsMesothelioma, Malignant

InterventionsNivolumab Ipilimumab Pemetrexed Cisplatin Carboplatin

DrugsPemetrexed Cisplatin Carboplatin

Overview

Phase: Phase 2
Intervention: Nivolumab
Conditions: Mesothelioma, Malignant
Sponsor: Bristol-Myers Squibb
Enrollment: 102
Locations: 26
Primary Endpoint: Overall Survival (OS)
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the efficacy and safety of the combination of nivolumab and ipilimumab in Chinese participants with malignant pleural mesothelioma.

Registry

clinicaltrials.gov

Start Date

January 25, 2022

End Date

November 12, 2025

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically proven diagnosis of Malignant Pleural Mesothelioma (MPM) with determination of epithelioid vs non-epithelioid histology
•Must have advanced unresectable disease that is not amenable to therapy with curative intent (surgery with or without chemotherapy)
•Available tumor samples for centralized testing
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
•Measurable disease

Exclusion Criteria

•Primitive peritoneal, pericardial, testis or tunica vaginalis mesothelioma
•Brain metastasis, except if surgically resected or treated with stereotaxic radiotherapy
•Prior therapy for MPM (including chemotherapy, radical pleuropneumonectomy and non-palliative radiotherapy)
•Other protocol-defined inclusion/exclusion criteria apply

Arms & Interventions

Arm A

Intervention: Nivolumab

Arm A

Intervention: Ipilimumab

Arm B

Intervention: Pemetrexed

Arm B

Intervention: Cisplatin

Arm B

Intervention: Carboplatin

Outcomes

Primary Outcomes

Overall Survival (OS)

Time Frame: Up to 58 months

Secondary Outcomes

Incidence of immune-related AEs(Up to 58 months)
Incidence of deaths(Up to 58 months)
Incidence of participants with laboratory abnormalities(Up to 58 months)
Objective Response Rate (ORR) by modified Response Evaluation Criteria in Solid Tumors (m-RECIST) by Investigator(Up to 58 months)
Progression Free Survival (PFS) by m-RECIST by Investigator(Up to 58 months)
Incidence of Adverse Events (AEs)(Up to 58 months)
Incidence of Serious Adverse Events (SAEs)(Up to 58 months)