A Study to Evaluate Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin for Unresectable Pleural Mesothelioma in Chinese Participants
- Conditions
- Mesothelioma, Malignant
- Interventions
- Registration Number
- NCT05136677
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Nivolumab - Arm A Ipilimumab - Arm B Pemetrexed - Arm B Carboplatin - Arm B Cisplatin -
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Up to 58 months
- Secondary Outcome Measures
Name Time Method Incidence of immune-related AEs Up to 58 months Incidence of deaths Up to 58 months Incidence of participants with laboratory abnormalities Up to 58 months Objective Response Rate (ORR) by modified Response Evaluation Criteria in Solid Tumors (m-RECIST) by Investigator Up to 58 months Progression Free Survival (PFS) by m-RECIST by Investigator Up to 58 months Incidence of Adverse Events (AEs) Up to 58 months Incidence of Serious Adverse Events (SAEs) Up to 58 months
Trial Locations
- Locations (26)
The First Affiliated Hospital of Zhengzhou Universtiy-Oncology department
🇨🇳Zhengzhou, Henan, China
Local Institution - 0012
🇨🇳Ningbo, Zhejiang, China
Beijing Cancer hospital-Thoracic Cancer Department A
🇨🇳Beijing, Beijing, China
Local Institution - 0005
🇨🇳Changsha, Hunan, China
Harbin Medical University Cancer Hospital-oncology of department
🇨🇳Harbin, Heilongjiang, China
Local Institution - 0017
🇨🇳Zhengzhou, Henan, China
Local Institution - 0008
🇨🇳Changsha, Hunan, China
Local Institution - 0023
🇨🇳Wuhan, Hunan, China
Local Institution - 0036
🇨🇳Hohhot, Inner Mongolia, China
Northern Jiangsu People's Hospital-General Surgery Department
🇨🇳Yangzhou, Jiangsu, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Local Institution - 0019
🇨🇳Shenyang, Liaoning, China
Liaoning Cancer Hospital-Oncology
🇨🇳Shenyang, Liaoning, China
Local Institution - 0021
🇨🇳Shenyang, Liaoning, China
Local Institution - 0030
🇨🇳Qingdao, Shandong, China
Local Institution - 0037
🇨🇳Jinan, Shandong, China
Shanghai Chest Hospital
🇨🇳Shanghai, Shanghai, China
Local Institution - 0034
🇨🇳Shanghai, Shanghai, China
Shanxi Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
Yunnan Province Cancer Hospital
🇨🇳Kunming, Yunnan, China
Zhejiang Cancer Hospital-Thoracic Surgery
🇨🇳Hangzhou, Zhejiang, China
Sichuan Cancer hospital
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University General Hospital-Oncology Department
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University Cancer Institute and Hospital-lung cancer
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital, Zhejiang University-Respiratory Department
🇨🇳Hangzhou, Zhejiang, China
Ningbo Medical Center-respiratory
🇨🇳Ningbo, Zhejiang, China