CompletedNot Applicable

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

Japan75 participantsStarted 2022-01-08

Plain-language 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).

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Adverse Events (AEs)

Timeframe: Up to 6 Months

Time to onset of serious adverse events (SAEs)

Timeframe: Up to 6 Months

Time to onset of AEs

Timeframe: Up to 6 Months

Time to resolution of AEs

Timeframe: Up to 6 Months

Time to resolution of SAEs

Timeframe: 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

Timeframe: Up to 6 Months

Incidence of physician seriousness assessment measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade - SAE

Timeframe: Up to 6 Months

Trial details

NCT IDNCT05324436

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Mesothelioma, Malignant trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of Adverse Events (AEs)

Timeframe: Up to 6 Months

Time to onset of serious adverse events (SAEs)

Timeframe: Up to 6 Months

Time to onset of AEs

Timeframe: Up to 6 Months

Time to resolution of AEs

Timeframe: Up to 6 Months

Time to resolution of SAEs

Timeframe: 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

Timeframe: Up to 6 Months

Incidence of physician seriousness assessment measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade - SAE

Timeframe: Up to 6 Months