A Study to Evaluate Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin for Unresectable Pleural Mesothelioma in Chinese Participants

NCT05136677 | Completed Phase 2 FDA Drug

• 2 other identifiers: CA209-6DWU1111-1265-3913
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 21

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.

Conditions

Mesothelioma, Malignant

Keywords

Malignant Pleural Mesothelioma (MPM); Nivolumab; Ipilimumab

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Up to 58 months

Secondary Outcomes (7)

• 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

• Incidence of immune-related AEs

  Up to 58 months

Study Arms (2)

Arm A

EXPERIMENTAL

Biological: Nivolumab; Biological: Ipilimumab

Arm B

EXPERIMENTAL

Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

Interventions

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-936558, Opdivo

Arm A

Ipilimumab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-734016, Yervoy

Arm A

Pemetrexed DRUG

Specified dose on specified days

Arm B

Cisplatin DRUG

Specified dose on specified days

Arm B

Carboplatin DRUG

Specified dose on specified days

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (21)

Local Institution - 0009

Beijing, Beijing Municipality, 100142, China

Location

Local Institution - 0013

Harbin, Heilongjiang, 150081, China

Location

Local Institution - 0006

Zhengzhou, Henan, 450003, China

Location

Local Institution - 0005

Changsha, Hunan, 410013, China

Location

Local Institution - 0023

Wuhan, Hunan, 430023, China

Location

Local Institution - 0015

Yangzhou, Jiangsu, 225001, China

Location

Local Institution - 0003

Changchun, Jilin, 130021, China

Location

Local Institution - 0004

Shenyang, Liaoning, 110042, China

Location

Local Institution - 0021

Shenyang, Liaoning, 110044, China

Location

Local Institution - 0037

Jinan, Shandong, 250117, China

Location

Local Institution - 0030

Qingdao, Shandong, 266003, China

Location

Local Institution - 0001

Shanghai, Shanghai Municipality, 200030, China

Location

Local Institution - 0033

Taiyuan, Shanxi, 030000, China

Location

Local Institution - 0029

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0007

Tianjin, Tianjin Municipality, 300052, China

Location

Local Institution - 0018

Tianjin, Tianjin Municipality, 300060, China

Location

Local Institution - 0010

Kunming, Yunnan, 650106, China

Location

Local Institution - 0014

Hangzhou, Zhejiang, 310003, China

Location

Local Institution - 0020

Hangzhou, Zhejiang, 310005, China

Location

Local Institution - 0012

Ningbo, Zhejiang, 315010, China

Location

Local Institution - 0016

Ningbo, Zhejiang, 315041, China

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Nivolumab; Ipilimumab; Pemetrexed; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: November 29, 2021
• Study Start: January 25, 2022
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

CN (21)