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A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies

A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01949 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

NCT03241173•Incyte Biosciences International Sàrl

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01949 when given in combination with immune therapies in participants with advanced or metastatic malignancies.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
•Phase 1: Subjects with advanced or metastatic solid tumors.
•Phase 1: Subjects who have disease progression after treatment with available therapies.
•Phase 2: Subjects with advanced or metastatic gastric cancer, SCCHN, NSCLC, or RCC and are considered refractory to prior PD-1/L1 therapy.
•Presence of measurable disease based on RECIST v1.1.
•Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.

Exclusion Criteria

•Laboratory and medical history parameters not within the Protocol-defined range
•Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
•Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.
•Active autoimmune disease.
•Known active central nervous system metastases and/or carcinomatous meningitis.
•Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
•Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
•Known history of human immunodeficiency virus (HIV); HIV 1/2 antibodies.

Locations (15)

The University of Alabama Birmingham (UAB)

Birmingham, Alabama, United States

Scottsdale Healthcare Hospitals DBA HonorHealth

Scottsdale, Arizona, United States

The Angeles Clinic and Research Institute

Los Angeles, California, United States

Mount Sinai Medical Center of Florida, Inc.

Miami, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

John Theurer Cancer Center At Hackensack UMC

Hackensack, New Jersey, United States

Rutgers, The State University

New Brunswick, New Jersey, United States

New York University Clinical Cancer Center

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Key Dates

Start Date

October 9, 2017

Primary Completion Date

September 17, 2019

Completion Date

September 17, 2019

Last Updated

September 27, 2022

Enrollment

ACTUAL participants

Conditions

Advanced Malignancies

Interventions

INCAGN01949

DRUG

Nivolumab

DRUG

Ipilimumab

DRUG

BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)

NCT04752826

Advanced MalignanciesOvarian Cancer+2 more

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RECRUITINGPHASE1

Study to Assess Safety, Tolerability and Activity of DSB2455 in Participants With Advanced Malignancies

NCT06458712

Advanced Malignancies With Homologous Recombination Deficiency (HRD) (Breast, Ovarian, mCRPC, Brain Metastases)

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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: September 27, 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.

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A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies

Inclusion Criteria

Exclusion Criteria

BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)

Study to Assess Safety, Tolerability and Activity of DSB2455 in Participants With Advanced Malignancies

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