A Study to Evaluate Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin for Unresectable Pleural Mesothelioma in Chinese Participants (CheckMate 6DW)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Mesothelioma, Malignant

Treatments: Drug: Pemetrexed; Biological: Nivolumab; Drug: Carboplatin; Biological: Ipilimumab; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05136677

CA209-6DW

U1111-1265-3913 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Arm A

Experimental group

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Arm B

Experimental group

Treatment:

Drug: Cisplatin

Drug: Carboplatin

Drug: Pemetrexed