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OpenTrials
Completed

NCT Number: NCT02909452

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

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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Key information

Conditions

Neoplasms Breast Diseases Bronchial Diseases Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Renal Neoplasm Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Solid Tumors Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The START Center for Cancer Care

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Entinostat

Drug

HDAC (histone deacetylase) inhibitor

Other names: SNDX-275, MS-275

Pembrolizumab

Drug

A selective humanized monoclonal antibody (mAb)

Other names: Keytruda, MK-3475, SCH-900475

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) resulting in the permanent discontinuation of study drug, and deaths occurring within the reporting period required for the study

    Time frame: Each treatment cycle is 21 days. All events will be collected from informed consent through 90 days post-last dose or through 30 days after initiation of new anti-cancer therapy

  2. Changes from baseline in laboratory results

    Time frame: Baseline through 90 day safety follow-up visit

  3. Changes from baseline in vital signs

    Time frame: Baseline through 90 day safety follow-up visit

  4. Changes from baseline in ECG results

    Time frame: Baseline through 90 day safety follow-up visit

Secondary outcomes

  1. AUC0-t (area under the curve to last observed concentration time) of entinostat when given in combination with pembrolizumab

    Time frame: Pre-dose through Cycle 3 Day 1

  2. AUC0-inf (area under the curve extrapolated to infinity) of entinostat when given in combination with pembrolizumab

    Time frame: Pre-dose through Cycle 3 Day 1

  3. Cmax (maximum plasma concentration) of entinostat when given in combination with pembrolizumab

    Time frame: Pre-dose through Cycle 3 Day 1

  4. Tmax (time to maximum plasma concentration) of entinostat when given in combination with pembrolizumab

    Time frame: Pre-dose through Cycle 3 Day 1

  5. T1/2 (elimination half life) of entinostat when given in combination with pembrolizumab

    Time frame: Pre-dose through Cycle 3 Day 1

  6. Vd (clearance and volume of distribution) of entinostat when given in combination with pembrolizumab

    Time frame: Pre-dose through Cycle 3 Day 1

Other outcomes

  1. Ratio of effector T cells to regulatory T cells in blood pre-therapy and post-therapy

    Time frame: Pre-dose through Cycle 3 Day 1

  2. Changes in the number of circulating immune related cells

    Time frame: Pre-dose through Cycle 3 Day 1

  3. Changes in protein lysine acetylation in peripheral blood cells pre-therapy and post-therapy

    Time frame: Pre-dose through Cycle 3 Day 1

  4. Best overall tumor response

    Time frame: Baseline up to 2 years

Sponsors and collaborators

Lead sponsor

Syndax Pharmaceuticals

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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)

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Sep 21, 2016
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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