Mesothelioma
Conditions
Sponsors
Bristol-Myers Squibb K.K.
Ono Pharmaceutical Co. Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males and Females at least 18 years of age Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery ECOG Performance status of 0 or 1 Available tumor sample for testing Acceptable blood work
Exclusion criteria
Exclusion criteria: Primitive peritoneal, pericardial and tunica vaginalis testis mesotheliomas Prior chemotherapy for pleural mesothelioma Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 oranti-CTLA-4 antibody History of other malignancy unless the subject has been disease-free for at least 3 years Active, untreated central nervous system (CNS) metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Overall Survival (OS) [ Time Frame: 3.5 years ] [ Designated as safety issue: Yes ] Progression Free Survival (PFS) [ Time Frame: 3.5 years ] [ Designated as safety issue: No ] | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Objective Response Rate (ORR) [ Time Frame: 3 years ] [ Designated as safety issue: No ] Disease Control Rate (DCR) [ Time Frame: 3 years ] [ Designated as safety issue: No ] Composite correlation of PD-L1 expression level and efficacy [ Time Frame: 3 years ] [ Designated as safety issue: No ] Efficacy determined by the ORR, PFS, and OS | — |
Countries
Japan
Outcome results
None listed