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Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206) | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206)

A Phase 1/2 Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Azacitidine in Combination With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors and Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Stage IV Microsatellite-Stable Colorectal Cancer (ECHO-206)

NCT02959437•Incyte Corporation

View on ClinicalTrials.gov

Summary

This is an open-label, Phase 1/2 study in subjects with advanced or metastatic solid tumors. The study has three separate treatment groups where separate epigenetic agents are evaluated with an immunotherapy combination. Treatment Group A will evaluate the DNA methyltransferase inhibitor azacitidine in combination with the programmed death receptor-1 (PD-1) inhibitor pembrolizumab and the indoleamine 2,3-dioxygenase (IDO-1) inhibitor epacadostat; Treatment Group B will evaluate the bromodomain and extra-terminal (BET) inhibitor INCB057643 with pembrolizumab and epacadostat; and Treatment Group C will evaluate the lysine-specific demethylase 1A (LSD1) inhibitor INCB059872 with pembrolizumab and epacadostat. The study will be divided into 2 parts (Part 1 and 2). Part 1 is a dose-escalation assessment to evaluate the safety and tolerability of the combination therapies. Once the recommended doses have been determined, subjects with previously treated NSCLC, microsatellite-stable colorectal cancer (CRC), head and neck squamous cell carcinoma, urothelial carcinoma, and melanoma will be enrolled into expansion cohorts in Part 2.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Willingness to provide written informed consent for the study.
•Willingness to undergo a pretreatment and on-treatment tumor biopsy to obtain tumor tissue.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•Part 1: Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (disease progression; subject refusal or intolerance is also allowable).
•Part 2:
•\*Note: Subjects must have failed available therapies that are known to confer clinical benefit as indicated below, unless they are ineligible, intolerant, or refused standard treatment.
•Subjects with histologically or cytologically confirmed NSCLC:
•* Metastatic (Stage IV) or recurrent NSCLC (according to American Joint Committee on Cancer 7th edition guidelines) who have had disease progression after available therapies for advanced or metastatic disease that are known to confer clinical benefit, been intolerant to treatment, or refused standard treatment.
•* Prior systemic regimens must include previously approved therapies, including a platinum-containing chemotherapy regimen; a tyrosine kinase inhibitor for tumors with driver mutations; and checkpoint inhibitors where approved.
•* Must have disease progression on a prior PD-1-pathway targeted agent.
+15 more criteria

Exclusion Criteria

•Laboratory parameters not within the protocol-defined range.
•Receipt of anticancer medications or investigational drugs within a defined interval before the first administration of study drug.
•Has not recovered from toxic effects of prior therapy to ≤ Grade 1.
•Active or inactive autoimmune disease or syndrome.
•Active infection requiring systemic therapy.
•Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
•History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful.
•Has received a live vaccine within 30 days of planned start of study therapy.
•Prior receipt of an IDO inhibitor.
•Subjects with uncontrolled type I or type II diabetes mellitus (defined as HgbA1c \> 8).
+4 more criteria

Locations (12)

City of Hope National Medical Center

Duarte, California, United States

University of California San Diego

La Jolla, California, United States

The University of Chicago

Chicago, Illinois, United States

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Sarah Cannon

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

Vall D Hebron Univ

Barcelona, Spain

Univ De Navarra

Pamplona, Spain

Key Dates

Start Date

February 27, 2017

Primary Completion Date

February 15, 2019

Completion Date

March 2, 2020

Last Updated

October 21, 2025

Enrollment

ACTUAL participants

Conditions

Solid TumorsAdvanced MalignanciesMetastatic Cancer

Interventions

Azacitidine

DRUG

Pembrolizumab

DRUG

Epacadostat

DRUG

INCB057643

DRUG

Pembrolizumab

DRUG

Epacadostat

DRUG

INCB059872

DRUG

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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RECRUITINGNA

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

NCT06658951

HER2-positive Advanced Malignant Solid Tumors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206)

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

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