Lymphoma, Colorectal Cancer, Head and Neck Cancer, Small Cell Lung Cancer, Skin Cancer, Genitourinary & Gynecologic Cancer, Glioblastoma

A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)

Incyte Study ID:
INCB 24360-204 / ECHO-204
CT.gov ID:
NCT02327078
View Results Summary
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
Bristol-Myers Squibb
Study Contact Information:
1-855-463-3463
Study Complete
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Results Available

Protocol
Available Languages: English
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Statistical Analysis Plan (SAP)
Available Languages: English
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Clinical Study Purpose

This is a Phase 1/2, open label study. Phase 1 consists of 2 parts. Part 1 is a dose-escalation assessment of the safety and tolerability of epacadostat administered with nivolumab in subjects with select advanced solid tumors and lymphomas. Part 2 will evaluate the safety and tolerability of epacadostat in combination with nivolumab and chemotherapy in subjects with squamous cell carcinoma of head and neck (SCCHN) and non-small cell lung cancer (NSCLC).

Phase 2 will include expansion cohorts in 7 tumor types, including melanoma, NSCLC, SCCHN, colorectal cancer, ovarian cancer, glioblastoma and diffuse large B-cell lymphoma (DLBCL).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Lymphoma
  • Colorectal Cancer
  • Head and Neck Cancer
  • Small Cell Lung Cancer
  • Skin Cancer
  • Genitourinary & Gynecologic Cancer
  • Glioblastoma
    • PRODUCT
  • Drug: Nivolumab
  • Drug: Epacadostat
  • Drug: Chemotherapy
    • COLLABORATORS
    Bristol-Myers Squibb
    DATE
    Nov 2014 - Jun 2020
    TYPE
    Interventional
    PHASE
    Phase 1/Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    UAB Comprehensive Cancer Center
    Birmingham, AL, US, 35294
    Name
    The Angeles Clinic and Research Institute
    Los Angeles, CA, US, 90025
    Name
    UCSF - University of California San Francisco
    San Francisco, CA, US, 94115
    Name
    University of Colorado Anschutz Medical Campus
    Aurora, CO, US, 80045
    Name
    University Cancer and Blood Center
    Athens, Georgia, US, 30607
    Name
    The University of Kansas Clinical Research Center
    Fairway, KS, US, 66205

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Male or female subjects, age 18 years or older
    • Subjects with histologically or cytologically confirmed NSCLC, MEL (including I/O relapsed MEL or I/O refractory MEL), CRC, SCCHN, ovarian cancer, recurrent B cell NHL or HL, or glioblastoma

    Exclusion Criteria

    • Laboratory and medical history parameters not within Protocol-defined range
    • Currently pregnant or breastfeeding

    Protocol Summary

    Incyte Study ID:
    INCB 24360-204 / ECHO-204
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    307
    Primary Outcome
    Open

    Phase 1, Part 1: Safety and tolerability of epacadostat and nivolumab assessed by number of subjects with dose limiting toxicities (DLTs)

    Timeframe: 42 days

    Phase 1, Part 2: Safety and tolerability of epacadostat administered in combination with nivolumab and chemotherapy regimen assessed by number of subjects with DLTs

    Timeframe: 42 days

    Phase 1, Part 1 and 2: Safety assessed by the frequency of adverse events, serious adverse events, and deaths

    Timeframe: From study start up to clinical data cut-off date of 01 Feb 2019

    Phase 2: Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for subjects with solid tumors and per Cheson criteria for subjects with DLBCL

    Timeframe: Response is assessed every 8 weeks up to 6 months

    Phase 2: Progression free survival (PFS)

    Timeframe: Response is assessed every 8 weeks up to 6 months

    Phase 2: Overall survival (OS) for subjects with Glioblatoma

    Timeframe: Subjects will be followed-up for survival every 12 weeks for a minimum of 9 months.

    Secondary Outcome
    Open

    Phase 1, Part 1: ORR per RECIST v1.1 and mRECIST for subjects with solid tumors; per Cheson and mCheson criteria for subjects with B-cell NHL; and per RANO and mRANO criteria for subjects with GBM

    Timeframe: Response will be assessed every 8 weeks during study participation which is estimated to be a minimum of 6 months.

    Phase 1, Part 2: ORR per RECIST v1.1 and modified RECIST for subjects with advanced or metastatic SCCHN and advanced or metastatic NSCLC

    Timeframe: Response will be assessed every 8 weeks during study participation which is estimated to be a minimum of 6 months.

    Phase 1, Part 2: Duration of response (DOR) for subjects with advanced or metastatic SCCHN and advanced or metastatic NSCLC

    Timeframe: Response will be assessed every 8 weeks during study participation which is estimated to be a minimum of 6 months.

    Phase 1, Part 2: PFS for subjects with advanced or metastatic SCCHN and advanced or metastatic NSCLC

    Timeframe: Response will be assessed every 8 weeks during study participation which is estimated to be a minimum of 6 months.

    Phase 2: Duration of response (DOR)

    Timeframe: Response will be assessed every 8 weeks during study participation which is estimated to be a minimum of 6 months.

    Phase 2: Duration of disease control, defined as CR, PR, and stable disease (SD)

    Timeframe: Response will be assessed every 8 weeks during study participation which is estimated to be a minimum of 6 months.

    Phase 2: Safety and tolerability measured by the frequency of adverse events (AEs), serious adverse events (SAEs), and deaths

    Timeframe: AEs are assessed for the duration of the study participation which is estimated to be a minimum of 27 months (24 months +100 day safety FU).