Spots Global Cancer Trial Database for Neoadjuvant Immune Checkpoint Blockade in Resectable Malignant Pleural Mesothelioma

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Trial Identification

Brief Title: Neoadjuvant Immune Checkpoint Blockade in Resectable Malignant Pleural Mesothelioma

Official Title: Neoadjuvant Immune Checkpoint Blockade in Resectable Malignant Pleural Mesothelioma

Study ID: NCT03918252

Conditions

Mesothelioma

Interventions

Nivolumab Injection

Ipilimumab Injection

Study Description

Brief Summary: The proposed study will evaluate the safety and feasibility of neoadjuvant nivolumab +/- ipilimumab in resectable MPM. In addition, maintenance nivolumab will be administered for 1 year following completion of standard bi-/tri-modality therapy.

Detailed Description: For Arm A 15 patients with resectable MPM will be enrolled and receive preoperative nivolumab, 240mg IV, on Day -42, -28 and Day -14 (+/- two days for each timepoint) prior to planned surgery on Day 0 (to allow for scheduling surgery may take place between Day -3 and Day +10). Subsequent to full accrual to Arm A, 15 patients with resectable MPM will be enrolled and receive preoperative nivolumab, 3mg/kg IV, on Day -42, -28 and Day -14 (+/- two days for each timepoint) + ipilimumab 1mg/kg IV on Day -42 prior to planned surgery on Day 0 (to allow for scheduling surgery may take place between Day -3 and Day +10).