A Study of Yervoy and Opdivo Combination Therapy in Participants With Unresectable Advanced/Recurrent Malignant Pleural Mesothelioma (MPM)

Study Overview
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Brief Summary
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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).

Official Title
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Special Drug Use Investigation (Survey) of Yervoy and Opdivo Combination Therapy in Patients With Unresectable Advanced/Recurrent Malignant Pleural Mesothelioma (MPM)

Conditions
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Mesothelioma, Malignant

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Initiated treatment with Yervoy and Opdivo in combination for the first time in accordance with the Japanese package insert Exclusion Criteria: Received combination therapy with Yervoy and Opdivo for indications other than Malignant Pleural Mesothelioma (MPM). Received the Yervoy and Opdivo combination for MPM, but for an indication that is outside of the Japanese package insert.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Participants with unresectable advanced/recurrent malignant pleural mesothelioma (MPM) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignant pleural mesothelioma (MPM), Opdivo, Yervoy, Unrectable, Advanced/recurrent