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

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ClinicalTrials.gov Identifier: NCT03361228
Recruitment Status : Active, not recruiting
First Posted : December 4, 2017
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: INCB001158 Drug: Epacadostat Drug: Pembrolizumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : May 21, 2018
Estimated Study Completion Date : November 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: INCB001158 + Epacadostat + Pembrolizumab 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.
Other Name: INCB024360

Drug: Pembrolizumab
Pembrolizumab at the protocol-defined dose administered intravenously every 3 weeks.
Other Name: MK-3475

Experimental: INCB001158 + Epacadostat 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.
Other Name: INCB024360




Primary Outcome Measures :
  1. 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) [ Time Frame: Up to approximately 12 months per subject ]
    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.

  2. Phase 2 only: Objective response rate (ORR) of INCB001158 in combination with epacadostat ± pembrolizumab [ Time Frame: Up to approximately 12 months per subject ]
    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).


Secondary Outcome Measures :
  1. Phase 2 only: Safety and tolerability of INCB001158 in combination with epacadostat ± pembrolizumab as assessed by number of participants with a TEAE [ Time Frame: Up to approximately 12 months per subject ]
    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.

  2. Phase 1 only: ORR with INCB001158 in combination with epacadostat ± pembrolizumab [ Time Frame: Up to approximately 12 months per subject ]
    Defined as percentage of subjects having a CR or PR based on investigator assessment per RECIST v1.1.

  3. Disease control rate with INCB001158 in combination with epacadostat ± pembrolizumab [ Time Frame: Up to approximately 12 months per subject ]
    Defined as percentage of subjects having CR, PR, or stable disease for at least 56 days based on investigator assessment per RECIST v1.1.

  4. Duration of response with INCB001158 in combination with epacadostat ± pembrolizumab [ Time Frame: Up to approximately 12 months per subject ]
    Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.

  5. Progression-free survival with INCB001158 in combination with epacadostat ± pembrolizumab [ Time Frame: Up to approximately 12 months per subject ]
    Defined as the time from date of first dose of study treatment until the earliest date of disease progression (based on investigator assessment of per RECIST v1.1) or death due to any cause, if occurring sooner than progression.

  6. Plasma pharmacokinetic profile of INCB001158 and epacadostat [ Time Frame: Up to approximately 1 month ]
    Noncompartmental method of analysis will be used to analyze the plasma concentrations of INCB001158 and epacadostat.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361228


Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294-3300
United States, Illinois
The University of Chicago Medicine
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Sven Gogov, MD Incyte Corporation

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03361228     History of Changes
Other Study ID Numbers: INCB 01158-202
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation:
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

Additional relevant MeSH terms:
Pembrolizumab
Antineoplastic Agents