Spots Global Cancer Trial Database for Continuation Study of Entinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: Continuation Study of Entinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

Official Title: A Phase 1, Randomized, Open-Label, Continuation Study of Entinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumors (SNDX-275-0141, MK3475-460/KEYNOTE-460)

Study ID: NCT02909452

Conditions

Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Carcinoma, Non-Small-Cell Lung

Interventions

Entinostat

Pembrolizumab

Study Description

Brief Summary: The objectives of this study are to explore different dosing levels and schedules of entinostat in combination with pembrolizumab in patients with advanced solid tumors, in terms of safety, tolerability, pharmacokinetics (PK), impact on immune correlatives, and efficacy

Detailed Description: This is a Phase 1, open-label, single center, randomized study to assess the safety and tolerability of 3 different dose regimens of entinostat in combination with pembrolizumab in patients with advanced solid tumors who previously completed Study SNDX-275-0140 (NCT02897778). Up to 30 patients will be randomized in a 1:1:1 fashion to one of three arms. In the event that greater than or equal to 2 out of the first 6 patients randomized experience a dose-limiting toxicity, the next patient randomized to that Arm will receive treatment at a reduced starting dose as outlined in the protocol.