Clinical trial NCT05136677: A Study to Evaluate Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin for Unresectable Pleural Mesothelioma in Chinese Participants
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Mesothelioma, Malignant
Keywords: Malignant Pleural Mesothelioma (MPM)
Nivolumab
Ipilimumab
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 58 months
Secondary outcomes:
measure: Objective Response Rate (ORR) by modified Response Evaluation Criteria in Solid Tumors (m-RECIST) by Investigator
timeFrame: Up to 58 months
measure: Progression Free Survival (PFS) by m-RECIST by Investigator
timeFrame: Up to 58 months
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 58 months
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 58 months
measure: Incidence of immune-related AEs
timeFrame: Up to 58 months
measure: Incidence of deaths
timeFrame: Up to 58 months
measure: Incidence of participants with laboratory abnormalities
timeFrame: Up to 58 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer hospital-Thoracic Cancer Department A
state: Beijing
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital-oncology of department
state: Heilongjiang
city: Zhengzhou
country: China
facility: Local Institution - 0017
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou Universtiy-Oncology department
state: Henan
city: Changsha
country: China
facility: Local Institution - 0008
state: Hunan
city: Changsha
country: China
facility: Local Institution - 0005
state: Hunan
city: Wuhan
country: China
facility: Local Institution - 0023
state: Hunan
city: Hohhot
country: China
facility: Local Institution - 0036
state: Inner Mongolia
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital-General Surgery Department
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Local Institution - 0019
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Cancer Hospital-Oncology
state: Liaoning
city: Shenyang
country: China
facility: Local Institution - 0021
state: Liaoning
city: Jinan
country: China
facility: Local Institution - 0037
state: Shandong
city: Qingdao
country: China
facility: Local Institution - 0030
state: Shandong
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Local Institution - 0034
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Cancer hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital-Oncology Department
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital-lung cancer
state: Tianjin
city: Kunming
country: China
facility: Yunnan Province Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University-Respiratory Department
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital-Thoracic Surgery
state: Zhejiang
city: Ningbo
country: China
facility: Local Institution - 0012
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Center-respiratory
state: Zhejiang
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: