NCT05324436

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

1.5 years

First QC Date

March 16, 2022

Last Update Submit

January 17, 2025

Conditions

Mesothelioma, Malignant

Keywords

Malignant pleural mesothelioma (MPM)OpdivoYervoyUnrectableAdvanced/recurrent

Outcome Measures

Primary Outcomes (15)

  • 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

Study Arms (1)

Cohort 1

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Initiated treatment with Yervoy and Opdivo in combination for the first time in accordance with the Japanese package insert

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Shinjuku-ku, Tokyo, 162-0822, Japan

Location

Related Links

MeSH Terms

Conditions

Mesothelioma, MalignantRecurrence

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2022

First Posted

April 12, 2022

Study Start

January 8, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

January 20, 2025

Record last verified: 2025-01

Locations

JP(1)