NCT03361228

A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat, With or Without Pembrolizumab, in Advanced Solid Tumors

An Open-Label, Multicenter, Nonrandomized, Dose-Escalation, and Tumor-Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat (INCB024360), With or Without Pembrolizumab, in Subjects With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and antitumor activity of INCB001158 plus epacadostat, with or without pembrolizumab, in participants with advanced or metastatic solid tumors.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	INCB001158	Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.
DRUG	Epacadostat	Epacadostat at the protocol-defined dose administered orally twice daily.
DRUG	Pembrolizumab	Pembrolizumab at the protocol-defined dose administered intravenously every 3 weeks.

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-03-30
• Completion: 2019-03-30
• First posted: 2017-12-04
• Last updated: 2020-05-21
• Results posted: 2020-05-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study