CompletedPhase 1 / Phase 2NCT03126110

Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.

Checked against the public recordLast updated Aug 14, 2025 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations38
SponsorIncyte Biosciences International Sàrl
01
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: INCAGN01876; Drug: Nivolumab; Drug: Ipilimumab
02
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 cervical cancer, gastric cancer (including stomach, esophageal, and GEJ), SCCHN, PD-1 refractory SCCHN and PD-1/PD-L1 relapsed melanoma. * 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 * Prior treatment with any tumor necrosis factor super family agonist. * 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 Angeles Clinic and Research InstituteLos Angeles, California
  • University of FloridaGainesville, Florida
  • Karmanos Cancer InstituteDetroit, Michigan
  • Washington University - Siteman Cancer CenterSt Louis, Missouri
  • Hackensack University Medical CenterHackensack, New Jersey
  • Memorial Sloan Kettering CancerNew York, New York
  • The University of North Carolina at Chapel HillChapel Hill, North Carolina
  • University of Oklahoma, Sarah Cannon Research InstituteOklahoma City, Oklahoma
  • Providance Portland Medical CenterPortland, Oregon
  • Fox Chase Cancer CenterPhiladelphia, Pennsylvania
  • University of Pittsburgh, UPMC Cancer PavilionPittsburgh, Pennsylvania
  • Tennessee Oncology, Sarah Cannon Research InstituteNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 14, 2025. Always confirm current availability with the study team.

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