Kidney Cancer Clinical Trial
Continuation Study of Entinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
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
Full 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.
Eligibility Criteria
Inclusion Criteria:
Completed Study SNDX-275-0140 (NCT02897778)
Any AE or toxicity experienced in Study SNDX-275-0140 (NCT02897778) is resolved to less than or equal to Grade 1
Continues to meet inclusion criteria for Study SNDX-275-0140 (NCT02897778) at the time of entry into this study
Exclusion Criteria:
Completed Study SNDX-275-0140 (NCT02897778) more than 30 days prior to Cycle 1 Day 1 of this study
Continues to meet exclusion criteria for Study SNDX-275-0140 (NCT02897778) at the time of entry into this study
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There is 1 Location for this study
San Antonio Texas, 78229, United States
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