Mesothelioma Unresectable
Conditions
Interventions
The medicinal interventions include nivolumab/ipilimumab combination therapy
(Arm A) and pemetrexed plus cisplatin or carboplatin chemotherapy (Arm B).
Sponsors
Bristol-Myers Squibb
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Male and female subjects (18 years of age and over). -Histologically proven diagnosis of (MPM), thoracoscopy is highly recommended. -Advanced unresectable disease that is not amenable to therapy with curative intent (surgery with or without chemotherapy). Subjects that refuse potentially curative surgery are ineligible. -Available (archival and/or fresh) pathological samples for centralized PD-L1 IHC testing during the screening period. Subjects cannot be randomized until the tumor tissue for PD-L1 testing has been received at the Central Lab, however, the result of the testing is not required prior to randomization. Subjects can initiate therapy before the result of PD-L1 testing is available. -Prior palliative radiotherapy is acceptable, but at least 14 days must have passed since the administration of the radiotherapy and all signs of toxicity must have remitted. -ECOG Performance Status of 0-1 -Weight loss
Exclusion criteria
Exclusion criteria: -Primitive peritoneal, pericardial and tunica vaginalis testis mesotheliomas -Brain metastasis, except if surgically resected or treated with stereotaxic radiotherapy with no evolution within the 3 months before inclusion, and asymptomatic. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival and the progression-free survival based on Blinded Independent Committee Review (BICR) assessment are the primary endpoints of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: *- Objective response rate (best overall response [BOR] is either a complete response [CR] or partial response [PR] per adapted m-RECIST and/or RECIST 1.1 criteria *- Disease control rate (BOR is CR, PR, or stable disease [SD]) *- PD-L1 expression level Exploratory Endpoints: *- Incidence rates of adverse events, serious adverse events, deaths, and laboratory abnormalities *- Serum concentrations of nivolumab in combination with ipilimumab *- The improvement of the EuroWol Group*s self-reported health status measure (EQ-5D) and EQ Vas score *- Disease-related symptom improvement rate evaluated by mesothelioma adaption of Lung Cancer Symptom Scale (LCSS-Meso) | — |
Countries
Netherlands
Outcome results
None listed