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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT02327078
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    specified dose and dosing schedule
  • Epacadostat — DRUG
    oral twice daily continuous at the protocol-defined dose
  • Chemotherapy — DRUG
    Specified dose on specified days

Study Details

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).

Key Dates

Start date
Nov 26, 2014
Status verified
Aug 2025
Primary completion
Jun 16, 2020
Completion
Jun 16, 2020

Study Design

Enrollment
307 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Part 1 Epacadostat 25mg BID +Nivolumab
    Epacadostat 25mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W
  • Experimental: Phase 1 Part 1 Epacadostat 50mg BID +Nivolumab
    Epacadostat 50mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W
  • Experimental: Phase 1 Part 1 Epacadostat 100mg BID +Nivolumab
    Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W.
  • Experimental: Phase 1 Part 1 Epacadostat 300mg BID +Nivolumab
    Epacadostat 300mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W.
  • Experimental: Phase 1 Part 2 Epacadostat 100mg BID +Nivolumab +5-FU/Platinum
    Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 360mg Q3W and 5-FU/Platinum( Carboplatin or Cisplatin+5-Fluorouracil) administered intravenously (IV).
  • Experimental: Phase 1 Part 2 Epacadostat 100mg BID +Pemetrexed/Platinum
    Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 360 mg Q3W and Pemetrexed/Platinum (Carboplatin orCisplatin+Pemetrexed) administered intravenously (IV).
  • Experimental: Phase 1 Part 2 Epacadostat 100mg BID +Paclitaxel/Platinum
    Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 360 mg Q3W and Paclitaxel/Platinum(Carboplatin+Cisplatin+Paclitaxel)administered intravenously (IV).
  • Experimental: Phase 2 Epacadostat 100mg BID + Nivolumab
    Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 240mg Q2W or 480 mg Q4W based on tumor type administered intravenously (IV).
  • Experimental: Phase 2 Epacadostat 300mg BID + Nivolumab
    Epacadostat 300mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 240mg Q2W administered intravenously (IV).

Primary Outcome Measure

Phase 1, Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Day 42 ]

Locations (22)

FacilityCityStateZIPSite coordinators
UAB Comprehensive Cancer CenterBirminghamAlabama35294-
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
USC Norris Cancer CenterLos AngelesCalifornia90033-
UCSF - University of California San FranciscoSan FranciscoCalifornia94115-
University of Colorado Anschutz Medical CampusAuroraColorado80045-
The University of Kansas Clinical Research CenterFairwayKansas66205-
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Lahey Hospital & Medical CenterBurlingtonMassachusetts01805-
Columbia University, Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
NYU Cancer CenterNew YorkNew York10016-
Duke University Medical CenterDurhamNorth Carolina27710-
Wake Forest Medical Center BoulevardWinston-SalemNorth Carolina27157-
Sanford ResearchFargoNorth Dakota58122-
University of Pittsburgh School of MedicinePittsburghPennsylvania15232-
Sanford ResearchNorth Sioux CitySouth Dakota57104-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Texas Oncology ResearchAustinTexas78705-
MD Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
Utah Cancer SpecialistsSalt Lake CityUtah84106-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

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OncologyNeuro-oncologyENTLung oncologyLung diseaseSkin cancerDermatologyGynecologic oncologyWomen's health
By research site
UAB Comprehensive Cancer Center· Birmingham, ALThe Angeles Clinic and Research Institute· Los Angeles, CAUSC Norris Cancer Center· Los Angeles, CAUCSF - University of California San Francisco· San Francisco, CAUniversity of Colorado Anschutz Medical Campus· Aurora, COThe University of Kansas Clinical Research Center· Fairway, KS

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