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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedINCAGN01949 and Nivolumab

Plus 1 other study approaches.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?15 U.S. locations

Locations may change over time.

Who runs it?Incyte Biosciences International Sàrl

Study sponsor

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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How this study is categorized

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

Disease setting

Metastatic or stage IV→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

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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