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Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers

A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of MK-3475 in Combination With INCB024360 in Subjects With Selected Cancers (ECHO-202/KEYNOTE-037)

NCT02178722•Incyte Corporation

View on ClinicalTrials.gov

Summary

The purpose of this study was to assess the safety, tolerability, and efficacy when combining MK-3475 and INCB024360 in participants with certain cancers. This study was conducted in 2 phases, Phase 1 and Phase 2.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects with histologically or cytologically non-small cell lung cancer (NSCLC), melanoma, transitional cell carcinoma of the genitourinary (GU) tract, renal cell cancer, triple negative breast cancer, adenocarcinoma of the endometrium or squamous cell carcinoma of the head and neck (Phase 1).
•Subjects with histologically confirmed melanoma, NSCLC, transitional cell carcinoma of the GU tract, TNBC, SCCHN, ovarian cancer, MSI high colorectal cancer (CRC), RCC, gastric cancer, HCC and DLBCL (Phase 2).
•Life expectancy \> 12 weeks.
•Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
•Presence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or Lugano Classification for subjects with DLBCL.
•Laboratory and medical history parameters within protocol-defined range.
•For Phase 1: Subjects who have advanced or metastatic disease as noted above that have received at least one prior therapy or have advanced or metastatic disease for which no curative treatment is available may be enrolled.
•For Phase 2 expansion cohorts: Subjects with NSCLC, melanoma (checkpoint inhibitor naïve, primary refractory melanoma, relapsed melanoma), transitional cell carcinoma of the GU tract, SCCHN, ovarian cancer, MSI high CRC, RCC, DLBCL, TNBC, gastric cancer, and HCC.
•* Phase 2 expansion: NSCLC
•* Subjects who have received at least 1 prior platinum-based therapy. Subjects who have a non-platinum-based regimen may be enrolled with medical monitor approval.
+48 more criteria

Exclusion Criteria

•* Barcelona Clinic Liver Cancer (BCLC) Stage C disease (Llovet et al 1999), or BCLC Stage B disease.
•* Subjects may have received no more than 2 lines of prior therapy for the advanced disease
•* Must have progressed on, refused, or were intolerant of sorafenib.
•* The following are excluded: Subjects with liver transplants, clear invasion of the bile duct or main portal branch(es), or hepatorenal syndrome, or subjects who have required esophageal variceal ablation within 28 days of starting study treatment.
•* Prior PD-1 or CTLA-4 targeted therapies are excluded.
•* Tumor biopsies are required. If a subject has inaccessible lesions, such as in ovarian cancer, HCC, or gastric cancer, or highly vascular lesions, such as RCC, enrollment may be considered with medical monitor approval, and archived tissue may be acceptable.
•* Females of child-bearing potential and males who use adequate birth control through 120 days post dose.
•Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 2 weeks or 5 half-lives (whichever is longer) prior to first dose.
•Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). Exception: Prior anti-CTLA-4 in the adjuvant setting for subjects with melanoma would be permitted.
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable.
+4 more criteria

Locations (24)

UC San Diego Moores Cancer Center

La Jolla, California, United States

The Angeles Clinic and Research Institute

Los Angeles, California, United States

US Davis Cancer Center

Sacramento, California, United States

University Of Colorado Cancer Center

Aurora, Colorado, United States

University of Connecticut Health Center Carole And Ray Neag Comprehensive Cancer Center

Farmington, Connecticut, United States

Miami Cancer Institute at Baptist Health, Inc

Miami, Florida, United States

Georgia Cancer Specialists affiliated with Northside Hospital Cancer Institute

Atlanta, Georgia, United States

The University of Chicago Medicine

Chicago, Illinois, United States

St. Francis Cancer Center

Topeka, Kansas, United States

Greater Baltimore Cancer Center

Baltimore, Maryland, United States

Key Dates

Start Date

July 17, 2014

Primary Completion Date

November 26, 2018

Completion Date

November 6, 2020

Last Updated

February 14, 2022

Enrollment

444

ACTUAL participants

Conditions

Microsatellite-instability (MSI) High Colorectal Cancer (CRC)Endometrial CancerHead and Neck CancerHepatocellular Carcinoma (HCC)Gastric CancerLung CancerLymphomaRenal Cell Carcinoma (RCC)Ovarian CancerSolid TumorsUC (Urothelial Cancer)MelanomaBladder CancerTriple Negative Breast Cancer (TNBC)

Interventions

MK-3475

DRUG

INCB024360

DRUG

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

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Endometrial CancerGastric Cancer+5 more

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RECRUITINGPHASE1/PHASE2

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

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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: February 14, 2022Data 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

Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers

Inclusion Criteria

Exclusion Criteria

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

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