Study on Durvalumab, Tremelimumab and chemotherapy for Mesothelioma (H-51512)

Combination of Induction Durvalumab and Tremelimumab alone versus Durvalumab and Tremelimumab with chemotherapy for Potentially Resectable Pleural Mesothelioma

The study will be a two-arm, randomized non-comparative Phase Ib/IIa study of induction dual immunotherapy with durvalumab/tremelimumab OR platinum chemotherapy (cisplatin or carboplatin) and pemetrexed chemotherapy plus dual immunotherapy with durvalumab/tremelimumab for 3 cycles in untreated, potentially resectable malignant pleural mesothelioma for all histologic subtypes and regardless PDL1 score. Patients will continue adjuvant durvalumab for up to 12 months following surgery. Tremelimumab will be given up to cycle five on treatment protocol.  We will enroll six patients to each arm to assess safety and resectability. If differences are not noted between the two arms, we will expand enrollment to 23 patients per arm. To account for up to 10% unevaluable patients, we will enroll at total of 52 patients. 

Safety in the first six patients in the chemotherapy plus immunotherapy arm will be determined by rate of attempted surgical resection.  If four or more patients undergo surgical resection, then the study will proceed to enroll the full 23 patient cohort. If three or less than three patients undergo surgical resection, the study will be paused for PI review of the enrolled patients to determine causality of the safety events.