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

NCT ID: NCT03361228

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-03-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

INCB001158 + Epacadostat + Pembrolizumab

Group Type: EXPERIMENTAL

INCB001158

Intervention Type: DRUG

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.

Epacadostat

Intervention Type: DRUG

Epacadostat at the protocol-defined dose administered orally twice daily.

Pembrolizumab

Intervention Type: DRUG

Pembrolizumab at the protocol-defined dose administered intravenously every 3 weeks.

INCB001158 + Epacadostat

Group Type: EXPERIMENTAL

INCB001158

Intervention Type: DRUG

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.

Epacadostat

Intervention Type: DRUG

Epacadostat at the protocol-defined dose administered orally twice daily.

Interventions

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.

Intervention Type: DRUG

Epacadostat

Epacadostat at the protocol-defined dose administered orally twice daily.

Intervention Type: DRUG

Pembrolizumab

Pembrolizumab at the protocol-defined dose administered intravenously every 3 weeks.

Intervention Type: DRUG

Other Intervention Names

INCB024360; MK-3475

Eligibility Criteria

Inclusion Criteria

• For Phase 1, subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (disease progression; subject intolerance is also allowable).
• For Phase 2, subjects with the following tumor types who meet protocol-defined criteria: advanced or metastatic NSCLC, melanoma, urothelial carcinoma, SCCHN, SCLC, and CRC.
• Presence of at least 1 measurable lesion by computed tomography or magnetic resonance imaging per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
• Resolution of all toxicities and any toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia). Subjects with ≤ Grade 2 neuropathy are an exception and may enroll.
• Adequate renal, hepatic, and hematologic functions per protocol-defined laboratory parameters within ≤ 7 days before treatment initiation.

Exclusion Criteria

• Participation in any other study in which receipt of an investigational study drug or device occurred within 2 weeks or 5 half-lives (whichever is longer) before first dose.
• Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.
• Prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.
• Prior therapy with an IDO1 or arginase 1 inhibitor.
• Active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Receipt of a live vaccine within 30 days before the first dose of study treatment.
• Any history of serotonin syndrome after receiving serotonergic drugs.
• Use of protocol-defined prior/concomitant therapy.
• Known or suspected defect in the function of the urea cycle.
• History of gastrointestinal condition that may affect drug absorption.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sven Gogov, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

University of Alabama

Birmingham, Alabama, United States

The University of Chicago Medicine

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

INCB 01158-202

Identifier Type: -

Identifier Source: org_study_id