NCT03241173

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

A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01949 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Incyte Biosciences International Sàrl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-10-09
• Primary completion: 2019-09-17
• Completion: 2019-09-17
• First posted: 2017-08-07
• Last updated: 2022-09-27
• Results posted: 2022-09-27

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study