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

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ClinicalTrials.gov Identifier: NCT02327078
Recruitment Status : Recruiting
First Posted : December 30, 2014
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

December 1, 2014
December 30, 2014
September 25, 2017
November 2014
April 2020   (Final data collection date for primary outcome 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 ]
  • Phase 1, Part 2: Safety and tolerability of epacadostat administered in combination with nivolumab and chemotherapy regimen assessed by number of subjects with DLTs [ Time Frame: 42 days ]
  • Phase 1, Part 1 and 2: Safety assessed by the frequency of adverse events, serious adverse events, and deaths [ Time Frame: Assessed through 100 days after the end of treatment, estimated to be up to 18 months per subject. ]
  • Phase 2: Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for subjects with solid tumors and per Cheson criteria for subjects with DLBCL [ Time Frame: Response is assessed every 8 weeks for the duration of study participation. ]
  • Phase 2: Progression free survival (PFS) [ Time Frame: Response is assessed every 8 weeks for the duration of study participation. ]
  • Phase 2: Overall survival (OS) [ Time Frame: Subjects will be followed-up for survival every 12 weeks for duration of study participation. ]
  • Phase 1: Evaluation of tolerability of INCB24360 and nivolumab measured by number of subjects with dose limiting toxicities (DLTs) [ Time Frame: 42 days ]
  • Safety measured by number of subjects with Adverse Events [ Time Frame: measured every 2 weeks for duration of participation which is estimated to be 18 months ]
  • Phase 2: Overall objective response rate (ORR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for select solid tumors or Cheson criteria for DLBCL [ Time Frame: assessed every 8 weeks for 24 weeks ]
Complete list of historical versions of study NCT02327078 on ClinicalTrials.gov Archive Site
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
Duration of response assessed based on ORR and progression-free survival (PFS) using RECIST v1.1 criteria for select solid tumors or Cheson criteria for B cell NHL or HL including DLBCL [ Time Frame: assessed every 8 weeks until either death or disease progression for up to 18 months ]
Not Provided
Not Provided
 
A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
A Phase 1/2 Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)

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).

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • I/O naïve Melanoma (MEL)
  • I/O Relapsed MEL
  • I/O Refractory MEL
  • Carcinoma, Non-Small-Cell Lung Cancer (NSCLC)
  • Colorectal Cancer (CRC)
  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • Ovarian Cancer
  • B Cell NHL Including DLBCL
  • HL
  • Glioblastoma
  • Drug: Nivolumab (Phase 1)
    specified dose and dosing schedule
  • Drug: Epacadostat (Phase 1)
    oral twice daily continuous at the protocol-defined dose
  • Drug: Chemotherapy (Phase 1)
    Specified dose on specified days
  • Drug: Nivolumab (Phase 2)
    specified dose and dosing schedule
  • Drug: Epacadostat (Phase 2)
    oral twice daily continuous at the protocol-defined dose
  • Experimental: (Phase 1, Part 1) : Nivolumab + Epacadostat
    Interventions:
    • Drug: Nivolumab (Phase 1)
    • Drug: Epacadostat (Phase 1)
  • Experimental: (Phase 2): Nivolumab + Epacadostat
    Interventions:
    • Drug: Nivolumab (Phase 2)
    • Drug: Epacadostat (Phase 2)
  • Experimental: (Phase 1, Part 2): Nivolumab + Epacadostat + Chemotherapy
    Interventions:
    • Drug: Nivolumab (Phase 1)
    • Drug: Epacadostat (Phase 1)
    • Drug: Chemotherapy (Phase 1)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
485
October 2020
April 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects, age 18 years or older
  • Subjects with histologically or cytologically confirmed NSCLC, 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Incyte Call Center 1-855-463-3463
United Kingdom,   United States
 
 
NCT02327078
INCB 24360-204 / ECHO-204
Yes
Not Provided
Not Provided
Incyte Corporation
Incyte Corporation
Bristol-Myers Squibb
Study Director: Gerard Kennealey, MD Incyte Corporation
Incyte Corporation
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP