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A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients with Recurrent Small Cell Lung Cancer: Big Ten Cancer Research Consortium BTCRC-LUN17-127
Primary Phase I: The primary objective of the Phase I dose escalation study is to establish the maximum tolerated dose (MTD) of plinabulin in combination with nivolumab and ipilimumab for patients with recurrent SCLC. Primary Phase II: The primary objective of the Phase II, 2-arm randomized study is to determine if the addition of plinabulin to double checkpoint inhibition (PD-1 and CTLA-4) for recurrent SCLC will improve progression-free survival (PFS, the time from treatment assignment to the date of the first documented tumor progression, or death due to any cause, whichever occurred first). Secondary: To assess toxicity and tolerability of the combination of nivolumab, ipilimumab and plinabulin. To compare the frequency of immune-related adverse events (irAEs) between the nivolumab/ipilimumab arm vs the nivolumab/ipilimumab/plinabulin arm. To determine the proportion of patients with a confirmed objective response in the 2 arms of the Phase II part (defined as the number of patients with a best overall response of complete response or partial response divided by the number of assigned patients). To estimate clinical benefit rate (CBR: complete response, partial response, or stable disease). To estimate 6-month (± 4 weeks) PFS. To estimate overall survival (OS) and 1-year OS. Exploratory: To compare biomarkers of inflammation (high sensitivity C-reactive protein [hsCRP], erythrocyte sedimentation rate [ESR], serum amyloid A [SAA]) between the nivolumab/ipilimumab arm vs the nivolumab/ipilimumab/plinabulin arm. To correlate tumor mutational burden with PFS and ORR.