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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 : March 6, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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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

Study Design
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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 2014
Estimated Primary Completion Date : July 18, 2020
Estimated Study Completion Date : July 18, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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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


Outcome Measures
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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 ]
  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 ]
  3. 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. ]
  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 for a minimum of 6 months. ]
  5. Phase 2: Progression free survival (PFS) [ Time Frame: Response is assessed every 8 weeks for a minimum of 6 months. ]
  6. Phase 2: Overall survival (OS) [ Time Frame: Subjects will be followed-up for survival every 12 weeks for a minimum of 6 months. ]

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). ]

Eligibility Criteria
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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
Contacts and Locations
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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
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United States, Alabama
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, California
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
USC Norris Cancer Center
Los Angeles, California, United States, 90033
UCSF - University of California San Francisco
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
United States, Kansas
The University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States, 01805
United States, New York
NYU Cancer Center
New York, New York, United States, 10016
Columbia University, Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest Medical Center Boulevard
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Sanford Research
Fargo, North Dakota, United States, 58122
United States, Pennsylvania
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15232
United States, South Dakota
Sanford Research
North Sioux City, South Dakota, United States, 57104
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology Research
Austin, Texas, United States, 78705
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Oxford University Hospitals NHS Trust
Oxford, United Kingdom, OX3 7LJ
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

More Information
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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: March 6, 2020
Last Verified: March 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