A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Participants With Advanced or Metastatic Malignancies (ECHO-208)
NCT ID: NCT03347123
Last Updated: 2022-02-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
11 participants
INTERVENTIONAL
2018-03-21
2021-01-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Epacadostat
Phase 1: Epacadostat at the protocol-defined dose twice daily. Phase 2: Epacadostat at the recommended dose from Phase 1.
Nivolumab
Nivolumab at the protocol-specified dose and schedule.
Ipilimumab
Ipilimumab at the protocol-specified dose and schedule.
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.
Epacadostat
Phase 1: Epacadostat at the protocol-defined dose twice daily. Phase 2: Epacadostat at the recommended dose from Phase 1.
Nivolumab
Nivolumab at the protocol-specified dose and schedule.
Ipilimumab
Ipilimumab at the protocol-specified dose and schedule.
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.
Epacadostat
Phase 1: Epacadostat at the protocol-defined dose twice daily. Phase 2: Epacadostat at the recommended dose from Phase 1.
Nivolumab
Nivolumab at the protocol-specified dose and schedule.
Lirilumab
Lirilumab at the protocol-specified dose and schedule.
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.
Epacadostat
Phase 1: Epacadostat at the protocol-defined dose twice daily. Phase 2: Epacadostat at the recommended dose from Phase 1.
Nivolumab
Nivolumab at the protocol-specified dose and schedule.
Lirilumab
Lirilumab at the protocol-specified dose and schedule.
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.
Epacadostat
Phase 1: Epacadostat at the protocol-defined dose twice daily. Phase 2: Epacadostat at the recommended dose from Phase 1.
Nivolumab
Nivolumab at the protocol-specified dose and schedule.
Ipilimumab
Ipilimumab at the protocol-specified dose and schedule.
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.
Epacadostat
Phase 1: Epacadostat at the protocol-defined dose twice daily. Phase 2: Epacadostat at the recommended dose from Phase 1.
Nivolumab
Nivolumab at the protocol-specified dose and schedule.
Ipilimumab
Ipilimumab at the protocol-specified dose and schedule.
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.
Epacadostat
Phase 1: Epacadostat at the protocol-defined dose twice daily. Phase 2: Epacadostat at the recommended dose from Phase 1.
Nivolumab
Nivolumab at the protocol-specified dose and schedule.
Lirilumab
Lirilumab at the protocol-specified dose and schedule.
Interventions
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Epacadostat
Phase 1: Epacadostat at the protocol-defined dose twice daily. Phase 2: Epacadostat at the recommended dose from Phase 1.
Nivolumab
Nivolumab at the protocol-specified dose and schedule.
Ipilimumab
Ipilimumab at the protocol-specified dose and schedule.
Lirilumab
Lirilumab at the protocol-specified dose and schedule.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* During Phase 2, participant with advanced cancer who have received at least one prior therapy or are treatment naive, depending on the specified tumor type.
* Presence of measurable disease per RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Expected survival of ≥ 12 weeks.
Exclusion Criteria
* Receipt of anticancer medications or investigational drugs within Protocol-defined time frames.
* Previous radiotherapy within 7 days of Cycle 1 Day 1.
* Known active central nervous system metastases and/or carcinomatous meningitis.
* Prior treatment with any immune checkpoint inhibitor and/or an IDO inhibitor.
* Active infection requiring systemic therapy.
* Any active or inactive autoimmune disease or syndrome
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor Consultant for Incyte
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
The Angeles Clinic and Research Institute
Los Angeles, California, United States
John Wayne Cancer Institute
Santa Monica, California, United States
Duke University Medical Center
Durham, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-001743-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 24360-208 (ECHO-208)
Identifier Type: -
Identifier Source: org_study_id
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