A Study of Yervoy and Opdivo Combination Therapy in Participants With Unresectable Advanced/Recurrent Malignant Pleural Mesothelioma (MPM)
Completed
- Conditions
- Mesothelioma, Malignant
- Registration Number
- NCT05324436
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to onset of AEs Up to 6 Months Time to resolution of AEs Up to 6 Months Incidence of AEs leading to interruption of treatment Up to 6 Months Incidence of SAEs leading to treatment discontinuation Up to 6 Months Incidence of AEs leading to treatment discontinuation 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 Outcome of reported SAEs Up to 6 Months Incidence of Adverse Events (AEs) Up to 6 Months Outcome of reported AEs Up to 6 Months Time to onset of serious adverse events (SAEs) 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 SAEs leading to interruption of treatment 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Local Institution
🇯🇵Shinjuku-ku, Tokyo, Japan