DuRvalumab With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma

Summary

Participation Requirements

Description

Mesothelioma is a malignant tumor of the mesothelial surfaces primarily arising in the thoracic pleura. In the United Kingdom and USA the expected number of cases in the next few decades are 65,000 and 85,000, respectively. Once diagnosed, this disease is rarely cured with a median survival of less ...

Mesothelioma is a malignant tumor of the mesothelial surfaces primarily arising in the thoracic pleura. In the United Kingdom and USA the expected number of cases in the next few decades are 65,000 and 85,000, respectively. Once diagnosed, this disease is rarely cured with a median survival of less than a year. This is an International, Open-Label, Multi-center, Phase III study. Patients will be randomized 2:1 to receive durvalumab with standard chemotherapy or to receive standard chemotherapy alone. Arm A: Durvalumab every 3 weeks + standard chemotherapy (Cisplatin every 3 weeks + Pemetrexed every 3 weeks) for 4 to 6 cycles, followed by Durvalumab every 4 weeks. Arm B: Standard chemotherapy (Cisplatin every 3 weeks + Pemetrexed every 3 weeks) for 4 to 6 cycles followed by observation. Treatment with durvalumab in Arm A will continued until disease progression, unacceptable toxicity or patient withdrawal. Tumor assessments and Quality of Life forms will be performed at baseline, then at weeks 6, 12, 18, 26, 34, 42, 50 and then every 12 weeks until disease progression. Mandatory pre-treatment tumor tissue sample (i.e., obtained during a previous procedure or biopsy) for research will also be required. Blood samples for research at baseline, day 1 of cycle 2, and day 1 of cycle 3 will be done. The study is being led jointly by PrECOG as the US sponsor and University of Sydney as the international sponsor

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