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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 : January 17, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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
I/O naïve Melanoma (MEL) I/O Relapsed MEL I/O Refractory MEL Carcinoma, Non-Small-Cell Lung CRC (Colorectal Cancer) HNSCC (Head and Neck Squamous Cell Cancer Ovarian Cancer B Cell NHL Including DLBCL Hodgkin Lymphona (B-cell Malignancies) 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 485 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 : April 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab
U.S. FDA Resources

Arms and Interventions

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

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 up to 18 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 the duration of study participation. ]
  5. Phase 2: Progression free survival (PFS) [ Time Frame: Response is assessed every 8 weeks for the duration of study participation. ]
  6. Phase 2: Overall survival (OS) [ Time Frame: Subjects will be followed-up for survival every 12 weeks for duration of study participation. ]

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 up to 18 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 up to 18 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 up to 18 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 up to 18 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 up to 42 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 up to 42 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 up to 18 months for Phase 1 and up to 42 months for Phase 2. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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, 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

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


Contacts
Contact: Incyte Call Center 1-855-463-3463

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States
United States, California
Recruiting
Los Angeles, California, United States
Recruiting
San Francisco, California, United States
United States, Colorado
Recruiting
Aurora, Colorado, United States
United States, Kansas
Recruiting
Fairway, Kansas, United States
United States, Maryland
Recruiting
Baltimore, Maryland, United States
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States
Recruiting
Burlington, Massachusetts, United States
United States, New York
Recruiting
New York, New York, United States
United States, North Carolina
Recruiting
Durham, North Carolina, United States
Recruiting
Winston-Salem, North Carolina, United States
United States, North Dakota
Recruiting
Fargo, North Dakota, United States
United States, Pennsylvania
Recruiting
Pittsburgh, Pennsylvania, United States
United States, South Dakota
Recruiting
North Sioux City, South Dakota, United States
United States, Tennessee
Recruiting
Nashville, Tennessee, United States
United States, Texas
Recruiting
Austin, Texas, United States
Recruiting
Houston, Texas, United States
United States, Utah
Recruiting
Salt Lake City, Utah, United States
United States, Wisconsin
Recruiting
Milwaukee, Wisconsin, United States
United Kingdom
Recruiting
Manchester, United Kingdom
Recruiting
Oxford, United Kingdom
Sponsors and Collaborators
Incyte Corporation
Bristol-Myers Squibb
Investigators
Study Director: Gerard Kennealey, MD Incyte Corporation
More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02327078     History of Changes
Other Study ID Numbers: INCB 24360-204 / ECHO-204
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Colorectal Neoplasms
Glioblastoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases