Clinical trial NCT02327078: A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
Official title: A Phase 1/2 Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: B-cell Malignancies
Colorectal Cancer (CRC)
Head and Neck Cancer
Lung Cancer
Lymphoma
Melanoma
Ovarian Cancer
Glioblastoma
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2014-12-30
Enrollment: 307
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: 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).


Eligibility 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
* Presence of measurable disease by RECIST v1.1 for solid tumors or Cheson criteria for B cell NHL (including DLBCL) or HL. For subjects with glioblastoma, presence of measurable disease is not required.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Fresh baseline tumor biopsies (defined as a biopsy specimen taken since completion of the most recent prior chemotherapy regimen) are required for all cohorts except glioblastoma

Exclusion Criteria:

* Laboratory and medical history parameters not within Protocol-defined range
* Currently pregnant or breastfeeding
* Subjects who have received prior immune checkpoint inhibitors or an IDO inhibitor (except select Phase 2 cohorts evaluating I/O relapsed or I/O refractory MEL). Subjects who have received experimental vaccines or other immune therapies should be discussed with the medical monitor to confirm eligibility
* Untreated central nervous system (CNS) metastases or CNS metastases that have progressed
* Subjects with any active or inactive autoimmune process
* Evidence of interstitial lung disease or active, noninfectious pneumonitis
* Subjects with any active or inactive autoimmune process
* Ocular MEL

Primary outcomes:
measure: Phase 1, Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
timeFrame: Day 42
measure: Phase 1, Part 2: Number of Participants With Dose Limiting Toxicities (DLTs)
timeFrame: Day 42
measure: Phase 1, Parts 1 and 2: Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: up to approximately 39 months
measure: Phase 2: Objective Response Rate (ORR) in Participants With Select Solid Tumors Per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 for Participants With Solid Tumors and Per Cheson Criteria for Participants With DLBCL
timeFrame: From first dose up end of the study (up to approximately 6 years)
measure: Phase 2: Progression Free Survival (PFS)
timeFrame: From first dose up end of the study (up to approximately 6 years)
measure: Phase 2: Overall Survival (OS) Rate of Proportion With Glioblastoma
timeFrame: Month 9
Secondary outcomes:
measure: Phase 1, Part 2: ORR Per RECIST v1.1 and for Participants With Advanced or Metastatic SCCHN and Advanced or Metastatic NSCLC
timeFrame: From first dose up end of the study (up to approximately 6 years)
measure: Phase 1, Part 1: ORR Per RECIST v1.1 for Participants With Solid Tumors; Per Cheson Criteria for Participants With B-cell NHL; and Per RANO and mRANO Criteria for Participants With GBM
timeFrame: From first dose up end of the study (up to approximately 6 years)
measure: Phase 1, Part 2: Duration of Response (DOR) for Participants With Advanced or Metastatic SCCHN and Advanced or Metastatic NSCLC
timeFrame: From first dose up end of the study (up to approximately 6 years)
measure: Phase 1, Part 2: PFS for Participants With Advanced or Metastatic SCCHN and Advanced or Metastatic NSCLC
timeFrame: From first dose up end of the study (up to approximately 6 years)
measure: Phase 2: Duration of Response
timeFrame: From first dose up end of the study (up to approximately 6 years)
measure: Phase 2: Duration of Disease Control, Defined as CR, PR, and Stable Disease (SD)
timeFrame: From first dose up end of the study (up to approximately 6 years)
measure: Phase 2: Safety and Tolerability Measured by the Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and Fatal Treatment Emergent AEs
timeFrame: up to approximately 35 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Comprehensive Cancer Center
state: Alabama
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Los Angeles
country: United States
facility: USC Norris Cancer Center
state: California
city: San Francisco
country: United States
facility: UCSF - University of California San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Fairway
country: United States
facility: The University of Kansas Clinical Research Center
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: New York
country: United States
facility: NYU Cancer Center
state: New York
city: New York
country: United States
facility: Columbia University, Herbert Irving Comprehensive Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Medical Center Boulevard
state: North Carolina
city: Fargo
country: United States
facility: Sanford Research
state: North Dakota
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
city: North Sioux City
country: United States
facility: Sanford Research
state: South Dakota
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology Research
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
Study officials:
affiliation: Incyte Corporation
name: Lance Leopold
role: STUDY_DIRECTOR
References: