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 | Local Institution - 0009 | 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 | Local Institution - 0013 | 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 | Local Institution - 0033 | 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 | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06057935 -
A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma
|
Phase 2 | |
| Completed |
NCT02519049 -
11C-Methionine PET/CT Imaging in Patients Affected by Malignant Pleural Mesothelioma (MPM)
|
||
| Recruiting |
NCT04104776 -
A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05429866 -
Immunological Variables Associated to ICI Toxicity in Cancer Patients
|
Phase 2 | |
| Recruiting |
NCT04981119 -
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
|
||
| Terminated |
NCT02357147 -
Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM)
|
Phase 2 | |
| Recruiting |
NCT06281860 -
Treatment Pleural Carcinosis of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin Administration
|
Phase 1 | |
| Completed |
NCT02303899 -
Combination of Gemcitabine and Imatinib Mesylate in Pemetrexed-pretreated Patients With Pleural Mesothelioma
|
Phase 2 | |
| Recruiting |
NCT05380713 -
......SMARTEST Trial......
|
Phase 2 | |
| Recruiting |
NCT05568680 -
SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma
|
Phase 1 | |
| Recruiting |
NCT06299163 -
NM32-2668 in Adult Patients With Selected Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT03502746 -
Phase II Nivolumab and Ramucirumab for Patients With Previously-Treated Mesothelioma
|
Phase 2 | |
| Active, not recruiting |
NCT05451849 -
A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06251310 -
SW-682 in Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05944237 -
HTL0039732 in Participants With Advanced Solid Tumours
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT05455424 -
Niraparib Efficacy in Patient With Unresectable Mesothelioma
|
Phase 2 | |
| Recruiting |
NCT05324436 -
A Study of Yervoy and Opdivo Combination Therapy in Participants With Unresectable Advanced/Recurrent Malignant Pleural Mesothelioma (MPM)
|
||
| Active, not recruiting |
NCT03654833 -
Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma
|
Phase 2 | |
| Not yet recruiting |
NCT05698238 -
Clinical Study to Evaluate Safety and Dosing of CA9hu-1 in Patients With Advanced Solid Tumours
|
Phase 1 | |
| Not yet recruiting |
NCT05188859 -
First Line Sintilimab Combined With Anlotinib and Platinum Doublet Chemotherapy in Malignant Pleural Mesothelioma
|
Phase 2 |