NCT03126110

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 145 (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 INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.

Conditions

• Advanced Malignancies
• Metastatic Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-04-25
• Primary completion: 2021-11-09
• Completion: 2021-11-09
• First posted: 2017-04-24
• Last updated: 2025-08-14
• Results posted: 2022-12-28

Locations

38 sites across 4 countries: United States, Australia, Belgium, Spain

Regulatory

• FDA-regulated drug study