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

NCT03126110 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2025-08-14

Study results available
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Summary

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.

Conditions

Interventions

DRUG

INCAGN01876

In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().

DRUG

Nivolumab

Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.

DRUG

Ipilimumab

Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.

Sponsors & Collaborators

  • Incyte Biosciences International Sàrl

    lead INDUSTRY

Principal Investigators

  • John E. Janik, MD · Incyte Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-25
Primary Completion
2021-11-09
Completion
2021-11-09
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03126110 on ClinicalTrials.gov