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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)

  • Clinicaltrials.gov identifier

    NCT05136677

  • Recruitment Status

    Recruiting

  • First Posted

    November 29, 2021

  • Last update posted

    May 12, 2022

Study Description

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:Mesothelioma, Malignant
  • Intervention/Treatment: Biological: Nivolumab
    Biological: Ipilimumab
    Drug: Pemetrexed
    Drug: Cisplatin
    Drug: Carboplatin
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study to Evaluate Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin for Unresectable Pleural Mesothelioma in Chinese Participants
  • Actual Study Start Date: January 2022
  • Estimated Primary Completion Date: October 2026
  • Estimated Study Completion Date: October 2026

Arms and interventions

Arm Intervention/treatment
Experimental: Arm A
Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Experimental: Arm B
Drug: Pemetrexed
Specified dose on specified days

Drug: Cisplatin
Specified dose on specified days

Drug: Carboplatin
Specified dose on specified days

Outcome Measures

  • 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 ]

Eligibility Criteria

  • 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

Contacts and Locations

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

China, Beijing
Local Institution
Beijing

China, Heilongjiang
Local Institution
Harbin

China, Henan
Local Institution
Zhengzhou

China, Hunan
Local Institution
Changsha

China, Hunan
Local Institution - 0005
Changsha

China, Jiangsu
Local Institution - 0015
Yangzhou

China, Jilin
Local Institution
Changchun

China, Liaoning
Local Institution
Shen Yang

China, Liaoning
Local Institution
Shenyang

China, Liaoning
Local Institution
Shenyang

China, Shanghai
Local Institution
Shanghai

China, Tianjin
Local Institution - 0007
Tianjin

China, Tianjin
Local Institution - 0018
Tianjin

China, Yunnan
Local Institution
Kunming

China, Zhejiang
Local Institution
Hangzhou

China, Zhejiang
Local Institution
Hangzhou

China, Zhejiang
Local Institution
Hangzhou

China, Zhejiang
Local Institution
Ningbo

China, Zhejiang
Local Institution
Ningbo

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT05136677 History of Changes
  • Other Study ID Numbers: CA209-6DW, U1111-1265-3913
  • First Posted: November 29, 2021 Key Record Dates
  • Last Update Posted: May 12, 2022
  • Last Verified: May 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: Malignant Pleural Mesothelioma (MPM)
    Nivolumab
    Ipilimumab
  • Additional relevant MeSH terms: 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