Mesothelioma, MalignantPhase 2CheckMate 6DWNCT05136677
A Study to Evaluate Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin for Unresectable Pleural Mesothelioma in Chinese Participants
A Phase 2 study testing Nivolumab, Ipilimumab and Pemetrexed in people with Mesothelioma, Malignant, run by Bristol-Myers Squibb at 21 sites in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of the combination of nivolumab and ipilimumab in Chinese participants with malignant pleural mesothelioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelioma, Malignant
- What is being tested?
- Nivolumab, Ipilimumab and Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 21 sitesChina
- Study dates
- 25 Jan 2022to 12 Nov 2025
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven diagnosis of Malignant Pleural Mesothelioma (MPM) with determination of epithelioid vs non-epithelioid histology
- Must have advanced unresectable disease that is not amenable to therapy with curative intent (surgery with or without chemotherapy)
- Available tumor samples for centralized testing
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- Measurable disease
Who cannot join
- Primitive peritoneal, pericardial, testis or tunica vaginalis mesothelioma
- Brain metastasis, except if surgically resected or treated with stereotaxic radiotherapy
- Prior therapy for MPM (including chemotherapy, radical pleuropneumonectomy and non-palliative radiotherapy)
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
China21 sites
Local Institution - 0009
Beijing, Beijing Municipality, 100142
Local Institution - 0003
Changchun, Jilin, 130021
Local Institution - 0005
Changsha, Hunan, 410013
Local Institution - 0029
Chengdu, Sichuan, 610041
Local Institution - 0014
Hangzhou, Zhejiang, 310003
Local Institution - 0020
Hangzhou, Zhejiang, 310005
Local Institution - 0013
Harbin, Heilongjiang, 150081
Local Institution - 0037
Jinan, Shandong, 250117
Local Institution - 0010
Kunming, Yunnan, 650106
Local Institution - 0012
Ningbo, Zhejiang, 315010
Local Institution - 0016
Ningbo, Zhejiang, 315041
Local Institution - 0030
Qingdao, Shandong, 266003
Local Institution - 0001
Shanghai, Shanghai Municipality, 200030
Local Institution - 0004
Shenyang, Liaoning, 110042
Local Institution - 0021
Shenyang, Liaoning, 110044
Local Institution - 0033
Taiyuan, Shanxi, 030000
Local Institution - 0007
Tianjin, Tianjin Municipality, 300052
Local Institution - 0018
Tianjin, Tianjin Municipality, 300060
Local Institution - 0023
Wuhan, Hunan, 430023
Local Institution - 0015
Yangzhou, Jiangsu, 225001
Local Institution - 0006
Zhengzhou, Henan, 450003
About this study
Official title: A Phase II, Randomized, Open-label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First-line Therapy for Unresectable Pleural Mesothelioma in Chinese Participants
The purpose of this study is to assess the efficacy and safety of the combination of nivolumab and ipilimumab in Chinese participants with malignant pleural mesothelioma.
- Conditions
- Mesothelioma, Malignant
- Being tested
- Nivolumab, Ipilimumab, Pemetrexed, Cisplatin, Carboplatin
- Keywords
- Malignant Pleural Mesothelioma (MPM), Nivolumab, Ipilimumab
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called BMS-936558, Opdivo
Specified dose on specified days
IpilimumabBiological
Also called BMS-734016, Yervoy
Specified dose on specified days
PemetrexedDrug
Specified dose on specified days
CisplatinDrug
Specified dose on specified days
CarboplatinDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Biological: Nivolumab; Biological: Ipilimumab |
| Arm B | Experimental | Not described Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: Up to 58 months
Secondary outcomes (7)
Objective Response Rate (ORR) by modified Response Evaluation Criteria in Solid Tumors (m-RECIST) by Investigator
Measured: Up to 58 months
Progression Free Survival (PFS) by m-RECIST by Investigator
Measured: Up to 58 months
Incidence of Adverse Events (AEs)
Measured: Up to 58 months
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 58 months
Incidence of immune-related AEs
Measured: Up to 58 months
Incidence of deaths
Measured: Up to 58 months
Incidence of participants with laboratory abnormalities
Measured: Up to 58 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start25 Jan 2022
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 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
- NCT05136677
- Sponsor's protocol ID
- CA209-6DW
- Other IDs
- U1111-1265-3913
- Acronym
- CheckMate 6DW
- Status last verified
- Jan 2026
- First submitted
- 18 Nov 2021
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Open-label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First-line Therapy for Unresectable Pleural Mesothelioma in Chinese Participants
- ClinicalTrials.gov ID
- NCT05136677
- Acronym / sponsor ID
- CheckMate 6DW / CA209-6DW
- Conditions
- Mesothelioma, Malignant
- Keywords
- Malignant Pleural Mesothelioma (MPM), Nivolumab, Ipilimumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 29 Nov 2021 (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 assess the efficacy and safety of the combination of nivolumab and ipilimumab in Chinese participants with malignant pleural mesothelioma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: Nivolumab, Biological: Ipilimumab |
| Arm B | Experimental | Drug: Pemetrexed, Drug: Cisplatin, Drug: Carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically proven diagnosis of Malignant Pleural Mesothelioma (MPM) with determination of epithelioid vs non-epithelioid histology
- Must have advanced unresectable disease that is not amenable to therapy with curative intent (surgery with or without chemotherapy)
- Available tumor samples for centralized testing
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- Measurable disease
Key exclusion criteria (4 listed)
- Primitive peritoneal, pericardial, testis or tunica vaginalis mesothelioma
- Brain metastasis, except if surgically resected or treated with stereotaxic radiotherapy
- Prior therapy for MPM (including chemotherapy, radical pleuropneumonectomy and non-palliative radiotherapy)
- Other protocol-defined inclusion/exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: BMS-936558, OpdivoSpecified dose on specified days | Biological | Arm A |
| IpilimumabAlso: BMS-734016, YervoySpecified dose on specified days | Biological | Arm A |
| PemetrexedSpecified dose on specified days | Drug | Arm B |
| CisplatinSpecified dose on specified days | Drug | Arm B |
| CarboplatinSpecified dose on specified days | Drug | Arm B |
Primary outcome
Overall Survival (OS)
Time frame: Up to 58 months
7 secondary outcomes
Objective Response Rate (ORR) by modified Response Evaluation Criteria in Solid Tumors (m-RECIST) by Investigator
Time frame: Up to 58 months
Progression Free Survival (PFS) by m-RECIST by Investigator
Time frame: Up to 58 months
Incidence of Adverse Events (AEs)
Time frame: Up to 58 months
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 58 months
Incidence of immune-related AEs
Time frame: Up to 58 months
Incidence of deaths
Time frame: Up to 58 months
Incidence of participants with laboratory abnormalities
Time frame: Up to 58 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 23 Jan 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink 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
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, Ipilimumab and Pemetrexed in people with Mesothelioma, Malignant, run by Bristol-Myers Squibb at 21 sites in China.
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 5 inclusion and 4 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 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Overall Survival (OS) (time frame: Up to 58 months). 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 23 Jan 2026.