Clinical trial NCT03347123: A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Participants With Advanced or Metastatic Malignancies (ECHO-208)
Official title: A Phase 1/2, Open-Label, Dose-Escalation, Safety, Tolerability, and Efficacy Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies (ECHO-208)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
Keywords: Epacadostat
nivolumab
ipilimumab
lirilumab
solid tumor
melanoma
non-small cell lung cancer (NSCLC)
squamous cell carcinoma of the head and neck (SCCHN)
IDO inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2017-11-20
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* During Phase 1, participant with locally advanced or metastatic solid tumors with disease progression on or after treatment with available therapies, or who are intolerant to treatment, or who refuse standard treatment.
* 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:

* Laboratory and medical history parameters not within the Protocol-defined range.
* 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

Primary outcomes:
measure: Phase 1: Percentage of Participants With At Least One Treatment Emergent Adverse Events (TEAEs)
timeFrame: Screening through up to 100 days after end of treatment, up to approximately 24 months
measure: Phase 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
timeFrame: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
Secondary outcomes:
measure: Phase 1: Objective Response Rate (ORR) Based on RECIST v1.1
timeFrame: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
measure: Phase 1: Duration of Response (DOR)
timeFrame: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
measure: Phase 1: Progression-free Survival (PFS)
timeFrame: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
measure: Phase 2: Duration of Response (DOR)
timeFrame: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
measure: Phase 2: Progression-free Survival (PFS)
timeFrame: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
measure: Phase 2: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Screening through up to 100 days for treatment Group A and 150 days for treatment Group B after end of treatment, up to approximately 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute
state: California
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Incyte Corporation
name: Medical Monitor Consultant for Incyte
role: STUDY_DIRECTOR
References: