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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 : Completed
First Posted : December 30, 2014
Last Update Posted : August 28, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Incyte Corporation

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).


Condition or disease Intervention/treatment Phase
B-cell Malignancies Colorectal Cancer (CRC) Head and Neck Cancer Lung Cancer Lymphoma Melanoma Ovarian Cancer Glioblastoma Drug: Nivolumab (Phase 1) Drug: Epacadostat (Phase 1) Drug: Chemotherapy (Phase 1) Drug: Nivolumab (Phase 2) Drug: Epacadostat (Phase 2) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 307 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 26, 2014
Actual Primary Completion Date : July 10, 2020
Actual Study Completion Date : July 10, 2020


Arm Intervention/treatment
Experimental: (Phase 1, Part 1) : Nivolumab + Epacadostat Drug: Nivolumab (Phase 1)
specified dose and dosing schedule

Drug: Epacadostat (Phase 1)
oral twice daily continuous at the protocol-defined dose

Experimental: (Phase 2): Nivolumab + Epacadostat 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 2): Nivolumab + Epacadostat + Chemotherapy 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




Primary Outcome Measures :
  1. 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 ]
    A DLT was defined as the occurrence of any of the toxicities occurring up to and including Day 42 in Phase 1 Parts 1 and 2.

  2. 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 ]
    A DLT was defined as the occurrence of any of the toxicities occurring up to and including Day 42 in Phase 1 Parts 1 and 2.

  3. Phase 1, Part 1 and 2: Safety assessed by the frequency of adverse events, serious adverse events, and deaths [ Time Frame: From study start up to clinical data cut-off date of 01 Feb 2019 ]
    A treatment-emergent adverse event (TEAE) is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and up to 100 days after last dose of study drug.

  4. 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 up to 6 months ]
    ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Cheson criteria for DLBCL and RANO criteria for Glioblastoma.

  5. Phase 2: Progression free survival (PFS) [ Time Frame: Response is assessed every 8 weeks up to 6 months ]
    PFS is defined as the time from randomization to the first documented progressive disease per RECIST v1.1 or death due to any cause, whichever occurs first.

  6. Phase 2: Overall survival (OS) for subjects with Glioblatoma [ Time Frame: Subjects will be followed-up for survival every 12 weeks for a minimum of 9 months. ]
    Overall survival is defined as the time from the date of the first dose of study treatment to death due to any cause.


Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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. ]
  6. 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. ]
  7. 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). ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02327078


Locations
Show Show 24 study locations
Sponsors and Collaborators
Incyte Corporation
Bristol-Myers Squibb
Investigators
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Study Director: Lance Leopold Incyte Corporation
  Study Documents (Full-Text)

Documents provided by Incyte Corporation:
Study Protocol  [PDF] May 31, 2018
Statistical Analysis Plan  [PDF] March 5, 2019

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02327078    
Other Study ID Numbers: INCB 24360-204 / ECHO-204
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Glioblastoma
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents