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Activity and Enhancement of Immune Checkpoint Inhibition with Lurbinectedin in Relapsed/Recurrent Small Cell Lung Cancer (SCLC)
This is a single-arm, phase I/II trial to determine the Maximum Tolerated Dose (MTD), Recommended Phase II Dose (RP2D), and the safety and efficacy of the combination of nivolumab-ipilimumab plus lurbinectedin in patients with relapsed/recurrent small cell lung cancer after progression with first-line, platinum-based chemotherapy
Primary Objective Phase I (Dose Escalation): To determine the MTD and RP2D of nivolumab-ipilimumab plus lurbinectedin. Primary Objective Phase II (Single Arm Cohort): To determine the efficacy of nivolumab-ipilimumab plus lurbinectedin in patients with relapsed/recurrent SCLC. Secondary Objectives: To further describe efficacy and to further describe safety. Tertiary/Exploratory Objectives: To examine potential predictive markers in the turmors of clinical responders. Characterize the evolution of the immune compartment during treatment. Determine Th1, Th2, and Th17 polarization during treatment with ipilimumab-nivolumab plus lurbinectedin.
BMS-936558 (Nivolumab); Ipilimumab (); Nivolumab (Opdivo); PM01183 (lurbinectedin); Yervoy (Ipilimumab); lurbinectedin ()