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

Mesothelioma, Malignant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05324436
• Other study ID #: CA209-6AF
• Status: Recruiting
• Start date: January 8, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2022
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Mesothelioma
• Mesothelioma, Malignant

Locations

Country	Name	City	State
Japan	Local Institution	Shinjuku-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)		Up to 6 Months
Primary	Time to onset of serious adverse events (SAEs)		Up to 6 Months
Primary	Time to onset of AEs		Up to 6 Months
Primary	Time to resolution of AEs		Up to 6 Months
Primary	Time to resolution of SAEs		Up to 6 Months
Primary	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
Primary	Incidence of physician seriousness assessment measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade - SAE		Up to 6 Months
Primary	Incidence of AEs leading to interruption of treatment		Up to 6 Months
Primary	Incidence of SAEs leading to interruption of treatment		Up to 6 Months
Primary	Incidence of AEs leading to treatment discontinuation		Up to 6 Months
Primary	Incidence of SAEs leading to treatment discontinuation		Up to 6 Months
Primary	Outcome of reported AEs		Up to 6 Months
Primary	Outcome of reported SAEs		Up to 6 Months
Primary	Number of participants with Yervoy and Opdivo treatment related adverse events as assessed by physician causality		Up to 6 Months
Primary	Number of participants with Yervoy and Opdivo treatment unrelated adverse events as assessed by physician causality		Up to 6 Months

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form