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Phase Ib/II clinical trial of pembrolizumab with bevacizumab for metastatic renal cell carcinoma: BTCRC-GU14-003

Journal of Clinical Oncology Mar 05, 2020

Dudek AZ, Liu LC, Gupta S, et al. - By performing a phase Ib/II, single-arm, multisite clinical trial, researchers tested the combination of bevacizumab and pembrolizumab in metastatic renal cell carcinoma (RCC) in order to determine whether bevacizumab will potentiate the activity of pembrolizumab. The participants included patients having metastatic clear cell RCC who had progression following at least one systemic therapy (phase Ib) or were treatment naïve (phase II). Every 3-week intravenous administration of pembrolizumab (200 mg) and bevacizumab (10 or 15 mg/kg) was performed in phase Ib. There were no dose-limiting toxicities. For phase II, experts opted pembrolizumab 200 mg and bevacizumab 15 mg/kg. The overall response rate reached 60.9% (primary endpoint was met), with 1 complete response (CR), 2 CRs in target lesions, 25 partial responses, 18 responses of stable disease, 2 unevaluable responses. The median progression-free survival was estimated to be 20.7 months. Hypertension and proteinuria were detected as the treatment-related grade 3 toxicities that occurred most commonly. Overall, in metastatic RCC, the safety, as well as the activity of the combination of 200 mg of pembrolizumab and a 15 mg/kg dose of bevacizumab administered every 3 weeks, was evident in this study.
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