A Study to Evaluate Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin for Unresectable Pleural Mesothelioma in Chinese Participants (CheckMate 6DW)
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| ClinicalTrials.gov Identifier: NCT05136677 |
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Recruitment Status :
Recruiting
First Posted : November 29, 2021
Last Update Posted : June 14, 2022
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mesothelioma, Malignant | Biological: Nivolumab Biological: Ipilimumab Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | January 25, 2022 |
| Estimated Primary Completion Date : | October 7, 2026 |
| Estimated Study Completion Date : | October 8, 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Mesothelioma
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm A |
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: Ipilimumab Specified dose on specified days
Other Names:
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| Experimental: Arm B |
Drug: Pemetrexed
Specified dose on specified days Drug: Cisplatin Specified dose on specified days Drug: Carboplatin Specified dose on specified days |
Primary Outcome Measures :
- Overall Survival (OS) [ Time Frame: Up to 58 months ]
Secondary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05136677
Contacts
| Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com | 855-907-3286 | Clinical.Trials@bms.com | |
| Contact: First line of the email MUST contain NCT # and Site #. |
Locations
Show 19 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT05136677 |
| Other Study ID Numbers: |
CA209-6DW U1111-1265-3913 ( Other Identifier: WHO ) |
| First Posted: | November 29, 2021 Key Record Dates |
| Last Update Posted: | June 14, 2022 |
| Last Verified: | June 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
Keywords provided by Bristol-Myers Squibb:
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Malignant Pleural Mesothelioma (MPM) Nivolumab Ipilimumab |
Additional relevant MeSH terms:
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Mesothelioma Mesothelioma, Malignant Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Pleural Neoplasms Lung Diseases |
Respiratory Tract Diseases Carboplatin Nivolumab Pemetrexed Ipilimumab Antineoplastic Agents Antineoplastic Agents, Immunological Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |