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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05324436

Collaborator

(none)

Enrollment

Location

38.7

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Mesothelioma, Malignant

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 8, 2022

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Mar 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 Participants with unresectable advanced/recurrent malignant pleural mesothelioma (MPM)

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.