Advertisement

Topics

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

2016-09-21 20:23:22 | BioPortfolio

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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Neoplasms

Intervention

Entinostat, Pembrolizumab

Location

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

Status

Recruiting

Source

Syndax Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-21T20:23:22-0400

Clinical Trials [230 Associated Clinical Trials listed on BioPortfolio]

Cardiac Safety Study of Entinostat in Men and Women With Advanced Solid Tumors

The purpose of this study is to evaluate the effect of entinostat on heart rate and other electrocardiogram parameters. This study will also evaluate the safety and tolerability of entinos...

Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer

The purpose of this study is to determine the effect of exemestane on the pharmacokinetics (PK) of entinostat and to determine the effect of entinostat on the PK of exemestane in patients ...

Entinostat in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors

This phase I trial studies the side effects and best dose of entinostat in treating pediatric patients with solid tumors that have come back or have not responded to treatment. Entinostat ...

Pembrolizumab in Treating Patients With HIV and Relapsed, Refractory, or Disseminated Malignant Neoplasms

This phase I trial studies the side effects of pembrolizumab in treating patients with human immunodeficiency virus (HIV) and malignant neoplasms that have come back (relapsed), do not res...

Randomized Phase 2 Study of Atezolizumab and Entinostat in Patients With aTN Breast Cancer With Phase 1b Lead In

The purpose of this study is to determine the safety and tolerability of entinostat used in combination with atezolizumab in patients with Advanced Triple Negative Breast Cancer (aTNBC). A...

PubMed Articles [518 Associated PubMed Articles listed on BioPortfolio]

Pembrolizumab-triggered Uveitis: An Additional Surrogate Marker for Responders in Melanoma Immunotherapy?

Immunotherapy leads to significantly prolonged survival of patients with metastatic melanoma. Autoimmune side effects including colitis, dermatitis, and endocrine abnormalities are common in patients ...

PEMBROLIZUMAB ADMINISTRATION ASSOCIATED WITH POSTERIOR UVEITIS.

To describe the development of uveitis and retinal vasculitis in association with pembrolizumab treatment for metastatic uveal melanoma.

Pembrolizumab-Induced Demyelinating Polyradiculoneuropathy.

This letter reports two cases of severe demyelinating polyradiculoneuropathy after treatment with pembrolizumab, a humanized antibody against programmed cell death 1 receptor, for advanced melanoma.

Prolonged benefit from ipilimumab correlates with improved outcomes from subsequent pembrolizumab.

Patients with metastatic melanoma who progress on ipilimumab can clearly derive benefit to subsequent anti-PD-1 (programmed death-1). However, patients experience heterogeneous outcomes with ipilimuma...

Patients with Nonpolypoid (Flat and Depressed) Colorectal Neoplasms at Increased Risk for Advanced Neoplasias, Compared to Patients With Polypoid Neoplasms.

Nonpolypoid colorectal neoplasms (NP-CRNs) are more likely to contain high-grade dysplasia or early-stage cancer than polypoid neoplasms. We aimed to determine the long-term outcomes of patients with ...

Medical and Biotech [MESH] Definitions

A collective term for precoordinated organ/neoplasm headings locating neoplasms by organ, as BRAIN NEOPLASMS; DUODENAL NEOPLASMS; LIVER NEOPLASMS; etc.

Cancers or tumors of the MAXILLA or MANDIBLE unspecified. For neoplasms of the maxilla, MAXILLARY NEOPLASMS is available and of the mandible, MANDIBULAR NEOPLASMS is available.

Benign and malignant neoplasms which occur within the substance of the spinal cord (intramedullary neoplasms) or in the space between the dura and spinal cord (intradural extramedullary neoplasms). The majority of intramedullary spinal tumors are primary CNS neoplasms including ASTROCYTOMA; EPENDYMOMA; and LIPOMA. Intramedullary neoplasms are often associated with SYRINGOMYELIA. The most frequent histologic types of intradural-extramedullary tumors are MENINGIOMA and NEUROFIBROMA.

Neoplasms located in the vasculature system, such as ARTERIES and VEINS. They are differentiated from neoplasms of vascular tissue (NEOPLASMS, VASCULAR TISSUE), such as ANGIOFIBROMA or HEMANGIOMA.

Neoplasms composed of cells from the deepest layer of the epidermis. The concept does not refer to neoplasms located in the stratum basale.

More From BioPortfolio on "Continuation Study of Entinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumors"

Quick Search
Advertisement
 

Relevant Topic

Cancer Disease
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...


Searches Linking to this Trial