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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
Recruitment Status : Recruiting
First Posted : November 29, 2021
Last Update Posted : June 14, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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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:
  • BMS-936558
  • Opdivo

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy

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 :
  1. Overall Survival (OS) [ Time Frame: Up to 58 months ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) by modified Response Evaluation Criteria in Solid Tumors (m-RECIST) by Investigator [ Time Frame: Up to 58 months ]
  2. Progression Free Survival (PFS) by m-RECIST by Investigator [ Time Frame: Up to 58 months ]
  3. Incidence of Adverse Events (AEs) [ Time Frame: Up to 58 months ]
  4. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 58 months ]
  5. Incidence of immune-related AEs [ Time Frame: Up to 58 months ]
  6. Incidence of deaths [ Time Frame: Up to 58 months ]
  7. Incidence of participants with laboratory abnormalities [ Time Frame: Up to 58 months ]


Information from the National Library of Medicine

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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
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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 Show 19 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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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

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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:
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