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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1265-3913 | Other Identifier | WHO |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Specified dose on specified days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Up to 58 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0009 | Beijing | Beijing Municipality | 100142 | China | ||
| Local Institution - 0013 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| Ipilimumab | Biological | Specified dose on specified days |
|
|
| Pemetrexed | Drug | Specified dose on specified days |
|
| Cisplatin | Drug | Specified dose on specified days |
|
| Carboplatin | Drug | Specified dose on specified days |
|
| 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 |
| Harbin |
| Heilongjiang |
| 150081 |
| China |
| Local Institution - 0006 | Zhengzhou | Henan | 450003 | China |
| Local Institution - 0005 | Changsha | Hunan | 410013 | China |
| Local Institution - 0023 | Wuhan | Hunan | 430023 | China |
| Local Institution - 0015 | Yangzhou | Jiangsu | 225001 | China |
| Local Institution - 0003 | Changchun | Jilin | 130021 | China |
| Local Institution - 0004 | Shenyang | Liaoning | 110042 | China |
| Local Institution - 0021 | Shenyang | Liaoning | 110044 | China |
| Local Institution - 0037 | Jinan | Shandong | 250117 | China |
| Local Institution - 0030 | Qingdao | Shandong | 266003 | China |
| Local Institution - 0001 | Shanghai | Shanghai Municipality | 200030 | China |
| Local Institution - 0033 | Taiyuan | Shanxi | 030000 | China |
| Local Institution - 0029 | Chengdu | Sichuan | 610041 | China |
| Local Institution - 0007 | Tianjin | Tianjin Municipality | 300052 | China |
| Local Institution - 0018 | Tianjin | Tianjin Municipality | 300060 | China |
| Local Institution - 0010 | Kunming | Yunnan | 650106 | China |
| Local Institution - 0014 | Hangzhou | Zhejiang | 310003 | China |
| Local Institution - 0020 | Hangzhou | Zhejiang | 310005 | China |
| Local Institution - 0012 | Ningbo | Zhejiang | 315010 | China |
| Local Institution - 0016 | Ningbo | Zhejiang | 315041 | China |
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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