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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05136677

Acronym

CheckMate 6DW

Enrollment

102

Registered

2021-11-29

Start date

2022-01-25

Completion date

2025-11-12

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mesothelioma, Malignant

Keywords

Malignant Pleural Mesothelioma (MPM), Nivolumab, Ipilimumab

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.

Interventions

BIOLOGICALNivolumab

Specified dose on specified days

BIOLOGICALIpilimumab

Specified dose on specified days

DRUGPemetrexed

Specified dose on specified days

DRUGCisplatin

Specified dose on specified days

DRUGCarboplatin

Specified dose on specified days

Sponsors

Bristol-Myers Squibb

Lead SponsorINDUSTRY

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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/

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS)	Up to 58 months

Secondary

Measure	Time frame
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
Incidence of deaths	Up to 58 months
Incidence of participants with laboratory abnormalities	Up to 58 months

Countries

China

Contacts

STUDY_DIRECTORBristol-Myers Squibb

Bristol-Myers Squibb

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026