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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-20

Study Completion Date

2021-02-09

Brief Summary

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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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Detailed Description

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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.

Conditions

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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 Lung Diseases Breast Diseases Renal Neoplasm Solid Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ENT 1mg daily with pembro every 3 weeks

Entinostat daily in combination with pembrolizumab every three weeks

Group Type ACTIVE_COMPARATOR

Entinostat

Intervention Type DRUG

HDAC (histone deacetylase) inhibitor

Pembrolizumab

Intervention Type DRUG

A selective humanized monoclonal antibody (mAb)

ENT 5mg weekly with pembro every 3 weeks

Entinostat once weekly in combination with pembrolizumab every three weeks

Group Type ACTIVE_COMPARATOR

Entinostat

Intervention Type DRUG

HDAC (histone deacetylase) inhibitor

Pembrolizumab

Intervention Type DRUG

A selective humanized monoclonal antibody (mAb)

ENT 10mg bi-weekly with pembro every 3 weeks

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

Group Type ACTIVE_COMPARATOR

Entinostat

Intervention Type DRUG

HDAC (histone deacetylase) inhibitor

Pembrolizumab

Intervention Type DRUG

A selective humanized monoclonal antibody (mAb)

Interventions

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Entinostat

HDAC (histone deacetylase) inhibitor

Intervention Type DRUG

Pembrolizumab

A selective humanized monoclonal antibody (mAb)

Intervention Type DRUG

Other Intervention Names

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SNDX-275 MS-275 Keytruda MK-3475 SCH-900475

Eligibility Criteria

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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