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

April 5, 2022 updated by: Bristol-Myers Squibb

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

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).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 162-0822
        • Recruiting
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will consist of participants with unresectable advanced/recurrent Malignant Pleural Mesothelioma (MPM) who will start the combination therapy for the first time under daily routine practice in Japan.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort 1
Participants with unresectable advanced/recurrent malignant pleural mesothelioma (MPM)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2022

Primary Completion (Anticipated)

September 30, 2024

Study Completion (Anticipated)

March 31, 2025

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

April 5, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-6AF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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