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

January 17, 2024 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Local Institution - 0009
        • Contact:
          • Site 0009
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Local Institution - 0013
        • Contact:
          • Site 0013
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou Universtiy-Oncology department
        • Contact:
          • zhiwei chang, Site 0006
          • Phone Number: 13526865540
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Local Institution - 0005
        • Contact:
          • Site 0005
      • Changsha, Hunan, China, 410008
        • Withdrawn
        • Local Institution - 0008
      • Wuhan, Hunan, China, 430023
        • Recruiting
        • Local Institution - 0023
        • Contact:
          • Site 0023
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010020
        • Not yet recruiting
        • Local Institution - 0036
        • Contact:
          • Site 0036
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225001
        • Recruiting
        • Northern Jiangsu People's Hospital-General Surgery Department
        • Contact:
          • Lingfeng Min, Site 0015
          • Phone Number: 18051061783
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The first hospital of Jilin University
        • Contact:
          • Jiuwei Cui, Site 0003
          • Phone Number: 8615843073215
    • Liaoning
      • Shenyang, Liaoning, China, 110044
        • Recruiting
        • Local Institution - 0021
        • Contact:
          • Site 0021
      • Shenyang, Liaoning, China, 110001
        • Withdrawn
        • Local Institution - 0019
      • Shenyang, Liaoning, China, 110042
        • Recruiting
        • Liaoning Cancer Hospital-Oncology
        • Contact:
          • Rui Ma, Site 0004
          • Phone Number: 13304006343
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Local Institution - 0037
        • Contact:
          • Site 0037
      • Qingdao, Shandong, China, 266003
        • Recruiting
        • Local Institution - 0030
        • Contact:
          • Site 0030
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
          • Zhen Zhou, Site 0001
          • Phone Number: 8618017321556
      • Shanghai, Shanghai, China, 200032
        • Not yet recruiting
        • Local Institution - 0034
        • Contact:
          • Site 0034
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Recruiting
        • Local Institution - 0033
        • Contact:
          • Site 0033
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Sichuan Cancer Hospital
        • Contact:
          • Jin Zhou, Site 0029
          • Phone Number: 18908190355
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital-Oncology Department
        • Contact:
          • Diansheng Zhong, Site 0007
          • Phone Number: 13821377353
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital-lung cancer
        • Contact:
          • Dongying Liu, Site 0018
          • Phone Number: 15332006050
    • Yunnan
      • Kunming, Yunnan, China, 650106
        • Recruiting
        • Yunnan Province Cancer Hospital
        • Contact:
          • YUNCHAO HUANG, Site 0010
          • Phone Number: 13708476546
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University-Respiratory Department
        • Contact:
          • Jianying Zhou, Site 0014
          • Phone Number: 8613505719970
      • Hangzhou, Zhejiang, China, 310005
        • Recruiting
        • Zhejiang Cancer Hospital-Thoracic Surgery
        • Contact:
          • Weimin Mao, Site 0020
          • Phone Number: 13606622335
      • Ningbo, Zhejiang, China, 315010
        • Recruiting
        • Local Institution - 0012
        • Contact:
          • Site 0012
      • Ningbo, Zhejiang, China, 315041
        • Recruiting
        • Ningbo Medical Center-respiratory
        • Contact:
          • Hongcheng Wu, Site 0016
          • Phone Number: 13806672744

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Carboplatin
Specified dose on specified days
Drug: Cisplatin
Specified dose on specified days
Drug: Pemetrexed
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to 58 months
Up to 58 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR) by modified Response Evaluation Criteria in Solid Tumors (m-RECIST) by Investigator
Time Frame: Up to 58 months
Up to 58 months
Progression Free Survival (PFS) by m-RECIST by Investigator
Time Frame: Up to 58 months
Up to 58 months
Incidence of Adverse Events (AEs)
Time Frame: Up to 58 months
Up to 58 months
Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 58 months
Up to 58 months
Incidence of immune-related AEs
Time Frame: Up to 58 months
Up to 58 months
Incidence of deaths
Time Frame: Up to 58 months
Up to 58 months
Incidence of participants with laboratory abnormalities
Time Frame: Up to 58 months
Up to 58 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2022

Primary Completion (Estimated)

October 7, 2026

Study Completion (Estimated)

October 8, 2026

Study Registration Dates

First Submitted

November 18, 2021

First Submitted That Met QC Criteria

November 18, 2021

First Posted (Actual)

November 29, 2021

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-6DW
  • U1111-1265-3913 (Other Identifier: WHO)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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