Mesothelioma, MalignantNCT05324436
A Study of Yervoy and Opdivo Combination Therapy in Participants With Unresectable Advanced/Recurrent Malignant Pleural Mesothelioma (MPM)
An observational study of Mesothelioma, Malignant, run by Bristol-Myers Squibb at 1 site in Japan.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mesothelioma, Malignant
- How many people
- 75 participants
- Where
- 1 siteJapan
- Study dates
- 8 Jan 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Initiated treatment with Yervoy and Opdivo in combination for the first time in accordance with the Japanese package insert
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Mesothelioma, Malignant
- Keywords
- Malignant pleural mesothelioma (MPM), Opdivo, Yervoy, Unrectable, Advanced/recurrent
- Medical subject headings
- Mesothelioma, Malignant, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with unresectable advanced/recurrent malignant pleural mesothelioma (MPM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Measured: Up to 6 Months
Time to onset of serious adverse events (SAEs)
Measured: Up to 6 Months
Time to onset of AEs
Measured: Up to 6 Months
Time to resolution of AEs
Measured: Up to 6 Months
Time to resolution of SAEs
Measured: 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
Measured: Up to 6 Months
Incidence of physician seriousness assessment measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade - SAE
Measured: Up to 6 Months
Incidence of AEs leading to interruption of treatment
Measured: Up to 6 Months
Incidence of SAEs leading to interruption of treatment
Measured: Up to 6 Months
Incidence of AEs leading to treatment discontinuation
Measured: Up to 6 Months
Incidence of SAEs leading to treatment discontinuation
Measured: Up to 6 Months
Outcome of reported AEs
Measured: Up to 6 Months
Outcome of reported SAEs
Measured: Up to 6 Months
Number of participants with Yervoy and Opdivo treatment related adverse events as assessed by physician causality
Measured: Up to 6 Months
Number of participants with Yervoy and Opdivo treatment unrelated adverse events as assessed by physician causality
Measured: Up to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start8 Jan 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesothelioma, MalignantStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324436
- Sponsor's protocol ID
- CA209-6AF
- Status last verified
- Jan 2025
- First submitted
- 16 Mar 2022
- Last updated
- 20 Jan 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation (Survey) of Yervoy and Opdivo Combination Therapy in Patients With Unresectable Advanced/Recurrent Malignant Pleural Mesothelioma (MPM)
- ClinicalTrials.gov ID
- NCT05324436
- Acronym / sponsor ID
- CA209-6AF
- Conditions
- Mesothelioma, Malignant
- Keywords
- Malignant pleural mesothelioma (MPM), Opdivo, Yervoy, Unrectable, Advanced/recurrent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants with unresectable advanced/recurrent malignant pleural mesothelioma (MPM) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Initiated treatment with Yervoy and Opdivo in combination for the first time in accordance with the Japanese package insert
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Up to 6 Months
Time to onset of serious adverse events (SAEs)
Time frame: Up to 6 Months
Time to onset of AEs
Time frame: Up to 6 Months
Time to resolution of AEs
Time frame: Up to 6 Months
Time to resolution of SAEs
Time frame: 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
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
Incidence of AEs leading to interruption of treatment
Time frame: Up to 6 Months
Incidence of SAEs leading to interruption of treatment
Time frame: Up to 6 Months
Incidence of AEs leading to treatment discontinuation
Time frame: Up to 6 Months
Incidence of SAEs leading to treatment discontinuation
Time frame: Up to 6 Months
Outcome of reported AEs
Time frame: Up to 6 Months
Outcome of reported SAEs
Time frame: 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
Number of participants with Yervoy and Opdivo treatment unrelated adverse events as assessed by physician causality
Time frame: Up to 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mesothelioma, Malignant, run by Bristol-Myers Squibb at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: Up to 6 Months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.