Mesothelioma, Malignant Clinical Trial
— CheckMate 6DWOfficial 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
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | October 8, 2026 |
| Est. primary completion date | October 7, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Cancer hospital-Thoracic Cancer Department A | Beijing | Beijing |
| China | The First Hospital of Jilin University | Changchun | Jilin |
| China | Local Institution - 0005 | Changsha | Hunan |
| China | Local Institution - 0008 | Changsha | Hunan |
| China | Sichuan Cancer hospital | Chengdu | Sichuan |
| China | The First Affiliated Hospital, Zhejiang University-Respiratory Department | Hangzhou | Zhejiang |
| China | Zhejiang Cancer Hospital-Thoracic Surgery | Hangzhou | Zhejiang |
| China | Harbin Medical University Cancer Hospital-oncology of department | Harbin | Heilongjiang |
| China | Local Institution - 0036 | Hohhot | Inner Mongolia |
| China | Local Institution - 0037 | Jinan | Shandong |
| China | Yunnan Province Cancer Hospital | Kunming | Yunnan |
| China | Local Institution - 0012 | Ningbo | Zhejiang |
| China | Ningbo Medical Center-respiratory | Ningbo | Zhejiang |
| China | Local Institution - 0030 | Qingdao | Shandong |
| China | Local Institution - 0034 | Shanghai | Shanghai |
| China | Shanghai Chest Hospital | Shanghai | Shanghai |
| China | Liaoning Cancer Hospital-Oncology | Shenyang | Liaoning |
| China | Local Institution - 0019 | Shenyang | Liaoning |
| China | Local Institution - 0021 | Shenyang | Liaoning |
| China | Shanxi Cancer Hospital | Taiyuan | Shanxi |
| China | Tianjin Medical University Cancer Institute and Hospital-lung cancer | Tianjin | Tianjin |
| China | Tianjin Medical University General Hospital-Oncology Department | Tianjin | Tianjin |
| China | Local Institution - 0023 | Wuhan | Hunan |
| China | Northern Jiangsu People's Hospital-General Surgery Department | Yangzhou | Jiangsu |
| China | Local Institution - 0017 | Zhengzhou | Henan |
| China | The First Affiliated Hospital of Zhengzhou Universtiy-Oncology department | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival (OS) | Up to 58 months | ||
| Secondary | Objective Response Rate (ORR) by modified Response Evaluation Criteria in Solid Tumors (m-RECIST) by Investigator | Up to 58 months | ||
| Secondary | Progression Free Survival (PFS) by m-RECIST by Investigator | Up to 58 months | ||
| Secondary | Incidence of Adverse Events (AEs) | Up to 58 months | ||
| Secondary | Incidence of Serious Adverse Events (SAEs) | Up to 58 months | ||
| Secondary | Incidence of immune-related AEs | Up to 58 months | ||
| Secondary | Incidence of deaths | Up to 58 months | ||
| Secondary | Incidence of participants with laboratory abnormalities | Up to 58 months |
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