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

Last updated: June 11, 2024
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

2

Condition

Lung Cancer

Mesothelioma

Treatment

Nivolumab

Pemetrexed

Ipilimumab

Clinical Study ID

NCT05136677
CA209-6DW
U1111-1265-3913
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically proven diagnosis of Malignant Pleural Mesothelioma (MPM) withdetermination of epithelioid vs non-epithelioid histology

  • Must have advanced unresectable disease that is not amenable to therapy withcurative 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

Exclusion Criteria:

  • Primitive peritoneal, pericardial, testis or tunica vaginalis mesothelioma

  • Brain metastasis, except if surgically resected or treated with stereotaxicradiotherapy

  • Prior therapy for MPM (including chemotherapy, radical pleuropneumonectomy andnon-palliative radiotherapy)

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 100
Treatment Group(s): 5
Primary Treatment: Nivolumab
Phase: 2
Study Start date:
January 25, 2022
Estimated Completion Date:
October 08, 2026

Connect with a study center

  • Beijing Cancer hospital-Thoracic Cancer Department A

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Local Institution - 0009

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital-oncology of department

    Harbin, Heilongjiang 150081
    China

    Active - Recruiting

  • Local Institution - 0013

    Harbin, Heilongjiang 150081
    China

    Active - Recruiting

  • Local Institution - 0006

    Zhengzhou, Henan 450003
    China

    Active - Recruiting

  • Local Institution - 0017

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou Universtiy-Oncology department

    Zhengzhou, Henan 450003
    China

    Active - Recruiting

  • Local Institution

    Changsha, Hunan 410008
    China

    Site Not Available

  • Local Institution - 0005

    Changsha, Hunan 410013
    China

    Active - Recruiting

  • Local Institution - 0008

    Changsha, Hunan 410008
    China

    Site Not Available

  • Local Institution - 0023

    Wuhan, Hunan 430023
    China

    Active - Recruiting

  • Local Institution - 0036

    Hohhot, Inner Mongolia 010020
    China

    Site Not Available

  • Local Institution - 0015

    Yangzhou, Jiangsu 225001
    China

    Active - Recruiting

  • Northern Jiangsu People's Hospital-General Surgery Department

    Yangzhou, Jiangsu 225001
    China

    Active - Recruiting

  • Local Institution - 0003

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • Local Institution

    Shen Yang, Liaoning 110044
    China

    Site Not Available

  • Liaoning Cancer Hospital-Oncology

    Shenyang, Liaoning 110042
    China

    Active - Recruiting

  • Local Institution

    Shenyang, Liaoning 110001
    China

    Site Not Available

  • Local Institution - 0004

    Shenyang, Liaoning 110042
    China

    Active - Recruiting

  • Local Institution - 0019

    Shenyang, Liaoning 110001
    China

    Site Not Available

  • Local Institution - 0021

    Shenyang, Liaoning 110044
    China

    Active - Recruiting

  • Local Institution - 0032

    Shenyang, Liaoning 110004
    China

    Site Not Available

  • Local Institution - 0037

    Jinan, Shandong 250117
    China

    Active - Recruiting

  • Local Institution - 0030

    Qingdao, Shandong 266003
    China

    Active - Recruiting

  • Local Institution - 0001

    Shanghai, Shanghai 200030
    China

    Active - Recruiting

  • Local Institution - 0034

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Shanghai Chest Hospital

    Shanghai, Shanghai 200030
    China

    Active - Recruiting

  • Local Institution - 0033

    Taiyuan, Shanxi 030000
    China

    Active - Recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi 030000
    China

    Active - Recruiting

  • Local Institution - 0029

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Sichuan Cancer hospital

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Local Institution - 0007

    Tianjin, Tianjin 300052
    China

    Active - Recruiting

  • Local Institution - 0018

    Tianjin, Tianjin 300060
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute and Hospital-lung cancer

    Tianjin, Tianjin 300060
    China

    Active - Recruiting

  • Tianjin Medical University General Hospital-Oncology Department

    Tianjin, Tianjin 300052
    China

    Active - Recruiting

  • Local Institution - 0010

    Kunming, Yunnan 650106
    China

    Active - Recruiting

  • Yunnan Province Cancer Hospital

    Kunming, Yunnan 650106
    China

    Active - Recruiting

  • Local Institution

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • Local Institution - 0014

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • Local Institution - 0020

    Hangzhou, Zhejiang 310005
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University-Respiratory Department

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital-Thoracic Surgery

    Hangzhou, Zhejiang 310005
    China

    Active - Recruiting

  • Local Institution - 0012

    Ningbo, Zhejiang 315010
    China

    Completed

  • Local Institution - 0016

    Ningbo, Zhejiang 315041
    China

    Active - Recruiting

  • Ningbo Medical Center-respiratory

    Ningbo, Zhejiang 315041
    China

    Active - Recruiting

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