Status: Closed
Activation Date: 2016OCT07
Closing Date: 2020SEP04
Phase: II-III
Description: A Phase II/III Randomized Study of Pembrolizumab in Patients with Advanced Malignant Pleural Mesothelioma
Eligibility: Patients must have histologically confirmed unresectable advanced and/or metastatic malignant pleural mesothelioma with available tumour block. No prior chemotherapy for advanced/metastatic disease. Prior (neo) adjuvant cisplatin-based systemic chemotherapy allowed if last dose > 12 months before registration. No prior targeted small molecule therapy, immunotherapies and viral therapies, biologic therapies and angiogenesis inhibitors for advanced/metastatic disease, or any prior immunotherapy for any stage of disease. Prior radiation therapy is permitted (< 30% BM), measurable disease outside the previously irradiated area is required. No diagnosis of immunodeficiency or is receiving systemic steroid therapy (doses > 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to first dose of trial treatment. No active autoimmune disease requiring systemic treatment < 3 years. No live attenuated vaccines within 30 days.
Objective: rimary - To evaluate whether pembrolizumab, alone or given to patients receiving standard chemotherapy, improves progression free survival in malignant pleural mesothelioma (MPM) compared to standard chemotherapy. Secondary To evaluate whether pembrolizumab improves overall survival when added to standard chemotherapy; To evaluate the tolerability of pembrolizumab, alone or given to patients receiving standard chemotherapy; To assess antitumour activity of pembrolizumab, alone or given to patients receiving standard chemotherapy including response rate and overall survival; To evaluate quality of life effects of pembrolizumab, alone or given to patients receiving standard chemotherapy. Exploratory - To explore the predictive and prognostic value of PD-L1 expression and presence of T cell subsets within the tumour microenvironment and other exploratory blood based biomarkers.
Participation: Limited to invited centres
Lay Description: This is an international, multicentre, randomized, Phase II/III trial that compares chemotherapy alone vs immunotherapy plus chemotherapy in patients with mesothelioma. The IND.227 study will collect important information regarding patients' quality of life, general health and the side effects of treatment. The researchers will also be doing tests on blood and tumour samples from participants to look for certain proteins and immune cells which may help predict which patients in the future are most likely benefit from the study drugs. This study will also examine response, overall survival and progression free survival and explore the relationship between certain biomarkers and outcomes of treatment.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I227 | 520 | 234 | 491 | 492 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I227 | 520 | 1 | 21 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I227 | 520 | 4 | 0 | 0 | 0 | 373 | 393 | 0 | 0 |