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

NCT03361228 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: INCB 01158-202
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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

Keywords

Non-small cell lung cancer (NSCLC); melanoma; urothelial carcinoma; squamous cell carcinoma of the head and neck (SCCHN); small cell lung cancer (SCLC); colorectal cancer (CRC); arginase 1 inhibitor; indoleamine 2,3-dioxygenase 1 inhibitor; programmed death-1 receptor (PD-1) inhibitor

Outcome Measures

Primary Outcomes (2)

• Phase 1 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a Treatment-emergent Adverse Event (TEAE)

  TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.

  Up to approximately 12 months per subject

• Phase 2 Only: Objective Response Rate (ORR) of INCB001158 in Combination With Epacadostat ± Pembrolizumab

  Defined as percentage of subjects having a complete response (CR) or partial response (PR) based on investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

  Up to approximately 12 months per subject

Secondary Outcomes (6)

• Phase 2 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a TEAE

  Up to approximately 12 months per subject

• Phase 1 Only: ORR With INCB001158 in Combination With Epacadostat ± Pembrolizumab

  Up to approximately 12 months per subject

• Disease Control Rate With INCB001158 in Combination With Epacadostat ± Pembrolizumab

  Up to approximately 12 months per subject

• Duration of Response With INCB001158 in Combination With Epacadostat ± Pembrolizumab

  Up to approximately 12 months per subject

• Progression-free Survival With INCB001158 in Combination With Epacadostat ± Pembrolizumab

  Up to approximately 12 months per subject

Study Arms (2)

INCB001158 + Epacadostat + Pembrolizumab

EXPERIMENTAL

Drug: INCB001158; Drug: Epacadostat; Drug: Pembrolizumab

INCB001158 + Epacadostat

EXPERIMENTAL

Drug: INCB001158; Drug: Epacadostat

Interventions

INCB001158 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.

INCB001158 + Epacadostat; INCB001158 + Epacadostat + Pembrolizumab

Epacadostat DRUG

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

Also known as: INCB024360

INCB001158 + Epacadostat; INCB001158 + Epacadostat + Pembrolizumab

Pembrolizumab DRUG

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

Also known as: MK-3475

INCB001158 + Epacadostat + Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (2)

University of Alabama

Birmingham, Alabama, 35294-3300, United States

Location

The University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Melanoma; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Small Cell Lung Carcinoma; Colorectal Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

epacadostat; pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Sven Gogov, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 4, 2017
• Study Start: March 1, 2018
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: May 21, 2020
• Results First Posted: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)