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Clinical Trial
. 2017 Sep 15;23(18):5349-5357.
doi: 10.1158/1078-0432.CCR-17-1243. Epub 2017 Jun 20.

Phase Ib Study of Utomilumab (PF-05082566), a 4-1BB/CD137 Agonist, in Combination with Pembrolizumab (MK-3475) in Patients with Advanced Solid Tumors

Anthony W Tolcher  1 , Mario Sznol  2 , Siwen Hu-Lieskovan  3 , Kyriakos P Papadopoulos  4 , Amita Patnaik  4 , Drew W Rasco  4 , Donna Di Gravio  5 , Bo Huang  6 , Dhiraj Gambhire  7 , Ying Chen  8 , Aron D Thall  8 , Nuzhat Pathan  8 , Emmett V Schmidt  9 , Laura Q M Chow  10
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Clinical Trial

VSports - Phase Ib Study of Utomilumab (PF-05082566), a 4-1BB/CD137 Agonist, in Combination with Pembrolizumab (MK-3475) in Patients with Advanced Solid Tumors

Anthony W Tolcher et al. Clin Cancer Res. .

Abstract

Purpose: This phase Ib study (NCT02179918) evaluated the safety, antitumor activity, pharmacokinetics, and pharmacodynamics of utomilumab, a fully human IgG2 mAb agonist of the T-cell costimulatory receptor 4-1BB/CD137 in combination with the humanized, PD-1-blocking IgG4 mAb pembrolizumab in patients with advanced solid tumors. Experimental Design: Utomilumab (0. 45-5. 0 mg/kg) and pembrolizumab (2 mg/kg) were administered intravenously every 3 weeks. Utomilumab dose escalation was conducted using the time-to-event continual reassessment method. Results: Twenty-three patients received combination treatment with no dose-limiting toxicities. Treatment-emergent adverse events were mostly grades 1 to 2, without any treatment-related discontinuations. Six patients (26. 1%) had confirmed complete or partial responses. Pharmacokinetics and immunogenicity of utomilumab and pembrolizumab were similar when administered alone or in combination. A trend toward higher levels of activated memory/effector peripheral blood CD8+ T cells was observed in responders versus nonresponders. Conclusions: The safety, tolerability, and clinical activity demonstrated by utomilumab in combination with pembrolizumab support further investigation in patients with advanced solid tumors. Clin Cancer Res; 23(18); 5349-57. ©2017 AACRSee related commentary by Pérez-Ruiz et al. , p VSports手机版. 5326. .

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