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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0009
Beijing, Beijing Municipality, China
Local Institution - 0013
Harbin, Heilongjiang, China
Overall Survival (OS)
Time frame: Up to 58 months
Objective Response Rate (ORR) by modified Response Evaluation Criteria in Solid Tumors (m-RECIST) by Investigator
Time frame: Up to 58 months
Progression Free Survival (PFS) by m-RECIST by Investigator
Time frame: Up to 58 months
Incidence of Adverse Events (AEs)
Time frame: Up to 58 months
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 58 months
Incidence of immune-related AEs
Time frame: Up to 58 months
Incidence of deaths
Time frame: Up to 58 months
Incidence of participants with laboratory abnormalities
Time frame: Up to 58 months
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Specified dose on specified days
Specified dose on specified days
Local Institution - 0006
Zhengzhou, Henan, China
Local Institution - 0005
Changsha, Hunan, China
Local Institution - 0023
Wuhan, Hunan, China
Local Institution - 0015
Yangzhou, Jiangsu, China
Local Institution - 0003
Changchun, Jilin, China
Local Institution - 0004
Shenyang, Liaoning, China
Local Institution - 0021
Shenyang, Liaoning, China
Local Institution - 0037
Jinan, Shandong, China
...and 11 more locations