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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05324436

Enrollment

Registered

2022-04-12

Start date

2022-01-08

Completion date

2023-06-30

Last updated

2025-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mesothelioma, Malignant

Keywords

Malignant pleural mesothelioma (MPM), Opdivo, Yervoy, Unrectable, Advanced/recurrent

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame
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
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 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

Countries

Japan

Outcome results