Open-label, Phase I Study of Nivolumab Combined with nab -Paclitaxel Plus Gemcitabine in Advanced Pancreatic Cancer

Assess safety and efficacy of nivolumab plus -paclitaxel and gemcitabine in patients with locally advanced/metastatic pancreatic cancer in a two-part, open-label, phase I trial. Fifty chemotherapy-naive patients received -paclitaxel 125 mg/m plus gemcitabine 1,000 mg/m (days 1, 8, and 15) and nivolu...

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Published in:Clinical cancer research 2020-09, Vol.26 (18), p.4814-4822
Main Authors: Wainberg, Zev A, Hochster, Howard S, Kim, Edward J, George, Ben, Kaylan, Aparna, Chiorean, E Gabriela, Waterhouse, David M, Guiterrez, Martin, Parikh, Aparna, Jain, Rishi, Carrizosa, Daniel Ricardo, Soliman, Hatem H, Lila, Thomas, Reiss, David J, Pierce, Daniel W, Bhore, Rafia, Banerjee, Sibabrata, Lyons, Larry, Louis, Chrystal U, Ong, Teng Jin, O'Dwyer, Peter J
Format: Article
Language:English
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Summary:Assess safety and efficacy of nivolumab plus -paclitaxel and gemcitabine in patients with locally advanced/metastatic pancreatic cancer in a two-part, open-label, phase I trial. Fifty chemotherapy-naive patients received -paclitaxel 125 mg/m plus gemcitabine 1,000 mg/m (days 1, 8, and 15) and nivolumab 3 mg/kg (days 1 and 15) in 28-day cycles. The primary endpoints were dose-limiting toxicities (DLTs; part 1) and grade 3/4 treatment-emergent adverse events (TEAEs) or treatment discontinuation due to TEAEs (parts 1/2). Secondary efficacy endpoints were progression-free survival (PFS), overall survival (OS), and response. Assessment of programmed cell death-ligand 1 (PD-L1) expression was an exploratory endpoint; additional biomarkers were assessed . One DLT (hepatitis) was reported in part 1 among six DLT-evaluable patients; 48 of 50 patients experienced grade 3/4 TEAEs and 18 discontinued treatment due to TEAEs. One grade 5 TEAE (respiratory failure) was reported. Median [95% confidence interval (CI)] PFS/OS was 5.5 (3.25-7.20 months)/9.9 (6.74-12.16 months) months, respectively [median follow-up for OS, 13.6 months (95% CI, 12.06-23.49 months)]. Overall response rate (95% CI) was 18% (8.6%-31.4%). Median PFS/OS was 5.5/9.7 months (PD-L1
ISSN:1078-0432
1557-3265
DOI:10.1158/1078-0432.CCR-20-0099