CompletedPhase 1 / Phase 2NCT03241173

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

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.

Checked against the public recordLast updated Sep 27, 2022 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations15
SponsorIncyte Biosciences International Sàrl
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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Incyte Biosciences International Sàrl
Interventions being studied
Drug: INCAGN01949; Drug: Nivolumab; Drug: Ipilimumab
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • The University of Alabama Birmingham (UAB)Birmingham, Alabama
  • Scottsdale Healthcare Hospitals DBA HonorHealthScottsdale, Arizona
  • The Angeles Clinic and Research InstituteLos Angeles, California
  • Mount Sinai Medical Center of Florida, Inc.Miami, Florida
  • University of MichiganAnn Arbor, Michigan
  • Barbara Ann Karmanos Cancer InstituteDetroit, Michigan
  • John Theurer Cancer Center At Hackensack UMCHackensack, New Jersey
  • Rutgers, The State UniversityNew Brunswick, New Jersey
  • New York University Clinical Cancer CenterNew York, New York
  • University of Rochester Medical CenterRochester, New York
  • Carolina BioOncology InstituteHuntersville, North Carolina
  • Providence Portland Medical CenterPortland, Oregon

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 27, 2022. Always confirm current availability with the study team.

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