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CheckMate 6DW: A Study to Evaluate Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin for Unresectable Pleural Mesothelioma in Chinese Participants

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05136677
Collaborator
(none)
100
Enrollment
19
Locations
2
Arms
56.4
Anticipated Duration (Months)
5.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 25, 2022
Anticipated Primary Completion Date :
Oct 7, 2026
Anticipated Study Completion Date :
Oct 8, 2026

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Objective Response Rate (ORR) by modified Response Evaluation Criteria in Solid Tumors (m-RECIST) by Investigator [Up to 58 months]

    2. Progression Free Survival (PFS) by m-RECIST by Investigator [Up to 58 months]

    3. Incidence of Adverse Events (AEs) [Up to 58 months]

    4. Incidence of Serious Adverse Events (SAEs) [Up to 58 months]

    5. Incidence of immune-related AEs [Up to 58 months]

    6. Incidence of deaths [Up to 58 months]

    7. Incidence of participants with laboratory abnormalities [Up to 58 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Local Institution - 0009 Beijing Beijing China 100142
    2 Local Institution - 0013 Harbin Heilongjiang China 150081
    3 Local Institution - 0006 Zhengzhou Henan China 450003
    4 Local Institution Changsha Hunan China 410008
    5 Local Institution - 0005 Changsha Hunan China 410013
    6 Local Institution - 0015 Yangzhou Jiangsu China 225001
    7 Local Institution - 0003 Changchun Jilin China 130021
    8 Local Institution Shenyang Liaoning China 110001
    9 Local Institution - 0004 Shenyang Liaoning China 110042
    10 Local Institution - 0021 Shenyang Liaoning China 110044
    11 Local Institution Shanghai Shanghai China 200030
    12 Local Institution - 0007 Tianjin Tianjin China 300052
    13 Local Institution - 0018 Tianjin Tianjin China 300060
    14 Local Institution Kunming Yunnan China 650118
    15 Local Institution Hangzhou Zhejiang China 310000
    16 Local Institution Hangzhou Zhejiang China 310003
    17 Local Institution - 0020 Hangzhou Zhejiang China 310005
    18 Local Institution Ningbo Zhejiang China 315040
    19 Local Institution Ningbo Zhejiang China 315200

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05136677
    Other Study ID Numbers:
    • CA209-6DW
    • U1111-1265-3913
    First Posted:
    Nov 29, 2021
    Last Update Posted:
    Jun 14, 2022
    Last Verified:
    Jun 1, 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
    Carboplatin
    Nivolumab
    Pemetrexed
    Ipilimumab

    Study Results

    No Results Posted as of Jun 14, 2022