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

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

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

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.

Entinostat

Pembrolizumab

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)

Entinostat daily in combination with pembrolizumab every three weeks

Entinostat once weekly in combination with pembrolizumab every three weeks

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

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?