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

Syndax Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Neoplasms, Glandular and Epithelial; Renal Neoplasm; Endocrine Gland Neoplasms; Digestive System Neoplasms; Solid Tumors; Respiratory Tract Neoplasms; Lung Neoplasms; Neoplasms by Histologic Type; Thoracic Neoplasms; Breast Diseases; Lung Diseases; Neoplasms; Carcinoma, Non-Small-Cell Lung; Bronchial Neoplasms

Treatments: Drug: Pembrolizumab; Drug: Entinostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT02909452

SNDX-275-0141

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Completed Study SNDX-275-0140 (NCT02897778)
2. Any AE or toxicity experienced in Study SNDX-275-0140 (NCT02897778) is resolved to less than or equal to Grade 1
3. Continues to meet inclusion criteria for Study SNDX-275-0140 (NCT02897778) at the time of entry into this study

Exclusion criteria

1. Completed Study SNDX-275-0140 (NCT02897778) more than 30 days prior to Cycle 1 Day 1 of this study
2. Continues to meet exclusion criteria for Study SNDX-275-0140 (NCT02897778) at the time of entry into this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

ENT 1mg daily with pembro every 3 weeks

Active Comparator group

Description:

Entinostat daily in combination with pembrolizumab every three weeks

Treatment:

Drug: Entinostat

Drug: Pembrolizumab

ENT 5mg weekly with pembro every 3 weeks

Active Comparator group

Description:

Entinostat once weekly in combination with pembrolizumab every three weeks

Treatment:

Drug: Entinostat

Drug: Pembrolizumab

ENT 10mg bi-weekly with pembro every 3 weeks

Active Comparator group

Description:

Entinostat once every other week in combination with pembrolizumab every three weeks

Treatment:

Drug: Entinostat

Drug: Pembrolizumab