A Study to Evaluate Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin for Unresectable Pleural Mesothelioma in Chinese Participants
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT05136677 Recruiting November 29, 2021 June 14, 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
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 - 0009 Beijing
China, Heilongjiang Local Institution - 0013 Harbin
China, Henan Local Institution - 0006 Zhengzhou
China, Hunan Local Institution Changsha
China, Hunan Local Institution - 0005 Changsha
China, Jiangsu Local Institution - 0015 Yangzhou
China, Jilin Local Institution - 0003 Changchun
China, Liaoning Local Institution Shenyang
China, Liaoning Local Institution - 0004 Shenyang
China, Liaoning Local Institution - 0021 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 - 0020 Hangzhou
China, Zhejiang Local Institution Ningbo
China, Zhejiang Local Institution Ningbo
Sponsors and Collaborators
Bristol-Myers Squibb
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Bristol-Myers Squibb
ClinicalTrials.gov Identifier : NCT05136677     
Other Study ID Numbers : CA209-6DW, U1111-1265-3913
First Posted : November 29, 2021
Last Update Posted : June 14, 2022
Last Verified : June 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