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Completed

NCT Number: NCT05136677

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 0009, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Biological

Specified dose on specified days

Other names: BMS-936558, Opdivo

Ipilimumab

Biological

Specified dose on specified days

Other names: BMS-734016, Yervoy

Pemetrexed

Drug

Specified dose on specified days

Cisplatin

Drug

Specified dose on specified days

carboplatin

Drug

Specified dose on specified days

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 58 months

Secondary outcomes

  1. Objective Response Rate (ORR) by modified Response Evaluation Criteria in Solid Tumors (m-RECIST) by Investigator

    Time frame: Up to 58 months

  2. Progression Free Survival (PFS) by m-RECIST by Investigator

    Time frame: Up to 58 months

  3. Incidence of Adverse Events (AEs)

    Time frame: Up to 58 months

  4. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 58 months

  5. Incidence of immune-related AEs

    Time frame: Up to 58 months

  6. Incidence of deaths

    Time frame: Up to 58 months

  7. Incidence of participants with laboratory abnormalities

    Time frame: Up to 58 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: CheckMate 6DW

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2021
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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