Clinical Trials /

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

NCT02327078

Description:

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).

Related Conditions:
  • Colorectal Carcinoma
  • Glioblastoma
  • Head and Neck Squamous Cell Carcinoma
  • Hodgkin Lymphoma
  • Melanoma
  • Non-Hodgkin Lymphoma
  • Non-Small Cell Lung Carcinoma
  • Ovarian Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: INCB 24360-204 / ECHO-204
  • NCT ID: NCT02327078

Conditions

  • B-cell Malignancies
  • Colorectal Cancer (CRC)
  • Head and Neck Cancer
  • Lung Cancer
  • Lymphoma
  • Melanoma
  • Ovarian Cancer
  • Glioblastoma

Interventions

DrugSynonymsArms
Nivolumab (Phase 1)(Phase 1, Part 1) : Nivolumab + Epacadostat
Epacadostat (Phase 1)(Phase 1, Part 1) : Nivolumab + Epacadostat
Chemotherapy (Phase 1)(Phase 1, Part 2): Nivolumab + Epacadostat + Chemotherapy
Nivolumab (Phase 2)(Phase 2): Nivolumab + Epacadostat
Epacadostat (Phase 2)(Phase 2): Nivolumab + Epacadostat

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
(Phase 1, Part 1) : Nivolumab + EpacadostatExperimental
  • Nivolumab (Phase 1)
  • Epacadostat (Phase 1)
(Phase 2): Nivolumab + EpacadostatExperimental
  • Nivolumab (Phase 2)
  • Epacadostat (Phase 2)
(Phase 1, Part 2): Nivolumab + Epacadostat + ChemotherapyExperimental
  • Nivolumab (Phase 1)
  • Epacadostat (Phase 1)
  • Chemotherapy (Phase 1)

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1, Part 1: Safety and tolerability of epacadostat and nivolumab assessed by number of subjects with dose limiting toxicities (DLTs)
Time Frame:42 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Phase 1, Part 1: ORR per RECIST v1.1 and mRECIST for subjects with solid tumors; per Cheson and mCheson criteria for subjects with B-cell NHL; and per RANO and mRANO criteria for subjects with GBM
Time Frame:Response will be assessed every 8 weeks during study participation which is estimated to be up to 18 months.
Safety Issue:
Description:
Measure:Phase 1, Part 2: ORR per RECIST v1.1 and modified RECIST for subjects with advanced or metastatic SCCHN and advanced or metastatic NSCLC
Time Frame:Response will be assessed every 8 weeks during study participation which is estimated to be up to 18 months.
Safety Issue:
Description:
Measure:Phase 1, Part 2: Duration of response (DOR) for subjects with advanced or metastatic SCCHN and advanced or metastatic NSCLC
Time Frame:Response will be assessed every 8 weeks during study participation which is estimated to be up to 18 months.
Safety Issue:
Description:
Measure:Phase 1, Part 2: PFS for subjects with advanced or metastatic SCCHN and advanced or metastatic NSCLC
Time Frame:Response will be assessed every 8 weeks during study participation which is estimated to be up to 18 months.
Safety Issue:
Description:
Measure:Phase 2: Duration of response (DOR)
Time Frame:Response will be assessed every 8 weeks during study participation which is estimated to be up to 42 months.
Safety Issue:
Description:
Measure:Phase 2: Duration of disease control, defined as CR, PR, and stable disease (SD)
Time Frame:Response will be assessed every 8 weeks during study participation which is estimated to be up to 42 months.
Safety Issue:
Description:
Measure:Phase 2: Safety and tolerability measured by the frequency of adverse events (AEs), serious adverse events (SAEs), and deaths
Time Frame:AEs are assessed for the duration of the study participation which is estimated to be up to 18 months for Phase 1 and up to 42 months for Phase 2.
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Incyte Corporation

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