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The purpose of this study is to observe the safety of the combination therapy with Yervoy and Opdivo in Japanese participants for the treatment of unresectable advanced/recurrent malignant pleural mesothelioma (MPM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants with unresectable advanced/recurrent malignant pleural mesothelioma (MPM) |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 6 Months | |
| Time to onset of serious adverse events (SAEs) | Up to 6 Months | |
| Time to onset of AEs | Up to 6 Months | |
| Time to resolution of AEs | Up to 6 Months | |
| Time to resolution of SAEs | Up to 6 Months | |
| Incidence of physician seriousness assessment measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade - Non-serious AE | Up to 6 Months | |
| Incidence of physician seriousness assessment measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade - SAE | Up to 6 Months | |
| Incidence of AEs leading to interruption of treatment | Up to 6 Months | |
| Incidence of SAEs leading to interruption of treatment | Up to 6 Months | |
| Incidence of AEs leading to treatment discontinuation | Up to 6 Months | |
| Incidence of SAEs leading to treatment discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of participants with unresectable advanced/recurrent Malignant Pleural Mesothelioma (MPM) who will start the combination therapy for the first time under daily routine practice in Japan.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Shinjuku-ku | Tokyo | 162-0822 | Japan |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Up to 6 Months |
| Outcome of reported AEs | Up to 6 Months |
| Outcome of reported SAEs | Up to 6 Months |
| Number of participants with Yervoy and Opdivo treatment related adverse events as assessed by physician causality | Up to 6 Months |
| Number of participants with Yervoy and Opdivo treatment unrelated adverse events as assessed by physician causality | Up to 6 Months |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |