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

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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.

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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

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT02909452

Recruitment Status:

Completed

Sponsor:

Syndax Pharmaceuticals

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There is 1 Location for this study

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The START Center for Cancer Care
San Antonio Texas, 78229, United States

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Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT02909452

Recruitment Status:

Completed

Sponsor:


Syndax Pharmaceuticals

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