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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02327078
Recruitment Status : Active, not recruiting
First Posted : December 30, 2014
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE December 1, 2014
First Posted Date  ICMJE December 30, 2014
Last Update Posted Date July 11, 2019
Actual Study Start Date  ICMJE November 2014
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • 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 a minimum of 6 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 a minimum of 6 months. ]
  • Phase 2: Progression free survival (PFS) [ Time Frame: Response is assessed every 8 weeks for a minimum of 6 months. ]
  • Phase 2: Overall survival (OS) [ Time Frame: Subjects will be followed-up for survival every 12 weeks for a minimum of 6 months. ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 23, 2014)
  • 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 ]
Change History Complete list of historical versions of study NCT02327078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • 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 a minimum of 6 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 a minimum of 6 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 a minimum of 6 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 a minimum of 6 months. ]
  • Phase 2: Duration of response (DOR) [ Time Frame: Response will be assessed every 8 weeks during study participation which is estimated to be a minimum of 6 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 a minimum of 6 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 a minimum of 27 months (24 months +100 day safety FU). ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2014)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
Official Title  ICMJE A Phase 1/2 Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • B-cell Malignancies
  • Colorectal Cancer (CRC)
  • Head and Neck Cancer
  • Lung Cancer
  • Lymphoma
  • Melanoma
  • Ovarian Cancer
  • Glioblastoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 3, 2018)
307
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2014)
221
Estimated Study Completion Date  ICMJE July 18, 2020
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02327078
Other Study ID Numbers  ICMJE INCB 24360-204 / ECHO-204
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director: Lance Leopold Incyte Corporation
PRS Account Incyte Corporation
Verification Date July 2019

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