A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Participants With Advanced or Metastatic Malignancies (ECHO-208)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT03347123
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • Epacadostat — DRUG
    Phase 1: Epacadostat at the protocol-defined dose twice daily. Phase 2: Epacadostat at the recommended dose from Phase 1.
  • Nivolumab — DRUG
    Nivolumab at the protocol-specified dose and schedule.
  • Ipilimumab — DRUG
    Ipilimumab at the protocol-specified dose and schedule.
  • Lirilumab — DRUG
    Lirilumab at the protocol-specified dose and schedule.

Study Details

The purpose of this study is to determine the safety, tolerability, and efficacy of epacadostat when given in combination with nivolumab and ipilimumab, and in combination with nivolumab and lirilumab, in participant with advanced or metastatic malignancies.

Key Dates

Start date
Mar 21, 2018
Status verified
Feb 2022
Primary completion
Jan 29, 2021
Completion
Jan 29, 2021

Study Design

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

Arms

  • Experimental: Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID
    Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
  • Experimental: Phase 1: Dose Escalation: Treatment Group A: Cohort 2 Epacadostat 100 mg BID
    Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
  • Experimental: Phase 1: Dose Escalation: Treatment Group B: Cohort 1 Epacadostat 50 mg BID
    Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of every 14 day cycle and lirilumab 240 mg IV every 4 weeks until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
  • Experimental: Phase 1: Dose Escalation: Treatment Group B: Cohort 2 Epacadostat 100 mg BID
    Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of every 14 day cycle and lirilumab 240 mg IV every 4 weeks until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
  • Experimental: Phase 2: Dose Expansion: Treatment Group A: Cohort A1
    Participants with unresectable or metastatic melanoma (MEL) were planned to be included in this cohort, who did not receive prior systemic therapy for advanced or metastatic disease to receive epacadostat in combination with nivolumab and ipilimumab at the MTD/PAD determined from dose escalation phase.
  • Experimental: Phase 2: Dose Expansion: Treatment Group A: Cohort A2
    Participants with advanced or metastatic non-small cell lung cancer (NSCLC) were planned to be included in this cohort, who have received no more than 1 prior line of platinum-based chemotherapy for advanced or metastatic disease to receive epacadostat in combination with nivolumab and ipilimumab at the MTD/PAD determined from dose escalation phase.
  • Experimental: Phase 2: Dose Expansion: Treatment Group B: Cohort B1
    Participants with recurrent or metastatic serotonin norepinephrine reuptake inhibitor (SCCHN) were planned to be included in this cohort, who received no more than 1 prior line of platinum-based chemotherapy for recurrent or metastatic disease to receive epacadostat in combination with nivolumab and lirilumab at the MTD/PAD determined from dose escalation phase.

Primary Outcome Measure

Phase 1: Percentage of Participants With At Least One Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Screening through up to 100 days after end of treatment, up to approximately 24 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
John Wayne Cancer InstituteSanta MonicaCalifornia90404-
Duke University Medical CenterDurhamNorth Carolina27710-
Vanderbilt University Medical CenterNashvilleTennessee37232-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALThe Angeles Clinic and Research Institute· Los Angeles, CAJohn Wayne Cancer Institute· Santa Monica, CADuke University Medical Center· Durham, NCVanderbilt University Medical Center· Nashville, TN

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