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

NCT03241173 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2022-09-27

Study results available
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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.

Conditions

  • Advanced Malignancies

Interventions

DRUG

INCAGN01949

In Phase 1, participants will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will receive INCAGN01949 administered IV 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
2017-10-09
Primary Completion
2019-09-17
Completion
2019-09-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03241173 on ClinicalTrials.gov