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TerminatedPhase 1 / Phase 2NCT03277352
Official study title

INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedINCAGN01876 and Epacadostat

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 Jul 22, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Incyte Biosciences International Sàrl

Study sponsor

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: Epacadostat; Drug: Pembrolizumab
02
Explore related studies

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→
03
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 melanoma, RCC, and urothelial carcinoma.
  • Presence of measurable disease based on RECIST v1.1.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
Reasons someone may not be able to joinExclusion 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
  • Hackensack University Medical CenterHackensack, New Jersey

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 22, 2021. Always confirm current availability with the study team.

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