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Trial record 1 of 1 for:    NCT02327078
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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Incyte Corporation
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT02327078
First received: December 1, 2014
Last updated: January 11, 2017
Last verified: January 2017
  Purpose
This is a Phase 1/2, open label study that will be conducted in 2 parts. The first part of the study (Phase 1) will consist of a dose-escalation assessment of the safety and tolerability of epacadostat administered with nivolumab in subjects with select advanced solid tumors and lymphomas including melanoma (MEL), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (SCCHN), ovarian cancer, and B cell non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL). The second part (Phase 2) of the study will include expansion cohorts in the tumor types tested in Phase 1 (except diffuse large B-cell lymphoma (DLBCL) will be the only lymphoma permitted and Phase 2 will also include a cohort for glioblastoma) with a) historically good activity with nivolumab monotherapy, and b) with historically low activity with nivolumab monotherapy.

Condition Intervention Phase
Melanoma
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Carcinoma, Squamous Cell of Head and Neck
Ovarian Neoplasms
B Cell NHL Including DLBCL
HL
Glioblastoma
Drug: Nivolumab + Epacadostat
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Phase 1: Evaluation of safety and tolerability of epacadostat and nivolumab measured by number of subjects with dose limiting toxicities (DLTs) [ Time Frame: 42 days ]
  • Safety measured by the frequency of adverse events, serious adverse events, and deaths [ Time Frame: measured every 2 weeks for duration of participation which is estimated to be 18 months ]
  • Phase 2: Overall objective response rate (ORR) and progression free survival (PFS) per modified RECIST v1.1 criteria for select solid tumors or Cheson criteria for B cell NHL (including DLBCL) or HL, or modified RANO criteria for glioblastoma [ Time Frame: assessed every 8 weeks for 6 months ]
  • Phase 2: Overall survival [ Time Frame: assessed at 9 months for subjects with glioblastoma ]

Secondary Outcome Measures:
  • Duration of response and duration of disease control assessed using modified RECIST v1.1 criteria for select solid tumors or Cheson criteria for B cell NHL (including DLBCL) or HL or modified RANO criteria for subjects with glioblastoma [ Time Frame: assessed every 8 weeks until either death or disease progression for up to 18 months ]
  • Progression free survival (PFS) rates will be assessed based on the tumor assessments using Response Evaluation Criteria In Solid Tumors modified (RECIST) v1.1 [ Time Frame: assessed every 8 weeks until either death or disease progression for up to 18 months ]
  • Phase 2: Safety and tolerability measured by the frequency of adverse events, serious adverse events, and deaths [ Time Frame: Adverse events are assessed every week for the duration of the study participation which is estimated to be approximately 18 months for Phase 1 and 42 months for Phase 2 ]

Estimated Enrollment: 291
Study Start Date: November 2014
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nivolumab + Epacadostat

Phase 1: Nivolumab 3 mg/kg once every 2 weeks + Epacadostat 25 mg BID as starting dose, followed by dose escalations (Phase 1) until recommended phase 2 dose of epacadostat BID is determined

Phase 2: Nivolumab 240 mg once every 2 weeks + epacadostat (BID dose that is determined in the Phase 1 portion of the study)

Drug: Nivolumab + Epacadostat
Epacadostat: Oral daily dosing; Nivolumab: IV infusion

  Eligibility

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
  • Subjects with Stage IIIB, Stage IV, or recurrent NSCLC; unresectable or Stage IV MEL; recurrent (unresectable) or metastatic CRC; recurrent (unresectable) or metastatic SCCHN; FIGO Stage Ic, II, III, or IV recurrent ovarian cancer (unresectable) or relapsed or refractory B cell NHL (including relapsed or refractory DLBCL) or HL, or glioblastoma and meet the following tumor specific criteria:

    • Subjects with Stage IIIB, Stage IV, or recurrent NSCLC:
    • Prior systemic therapies must include a platinum-based regimen
    • All subjects must be screened for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) fusion oncogene status and if positive treated with a tyrosine kinase inhibitor
    • Malignancy must be deemed unresectable
  • Subjects with unresectable or Stage IV MEL:

    • Documentation of V600E-activating BRAF mutation status or consent to BRAF V600E mutation testing during the screening period
    • Subjects may be treatment-naïve or have received only 1 prior treatment for advanced or metastatic disease
  • Subjects with recurrent (unresectable) or metastatic CRC:

    • Histologically or cytologically confirmed adenocarcinoma of the colon or rectum
    • Prior treatment: Progression following last administration of approved standard therapies
  • Subjects with recurrent or metastatic SCCHN:

    • Metastatic or recurrent squamous cell carcinoma not amenable to local therapy with curative intent (surgery or radiation with or without chemotherapy)

      -Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx and salivary gland or non-squamous histologies will be excluded

    • Documentation of human papillomavirus status (eg, p16-status) of tumor
  • Subjects with International Federation of Gynecology and Obstetrics (FIGO) Stage Ic, Stage II, Stage III, Stage IV, recurrent, or persistent (unresectable) histologically confirmed epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube carcinoma:

    • Subjects must have received a platinum-taxane-based regimen as frontline therapy
    • Borderline, low malignant potential epithelial carcinoma per histopathology is excluded
  • Subjects with relapsed or recurrent B cell NHL or HL (including relapsed or refractory DLBCL excluding Burkitt's lymphoma and precursor B-lymphoblastic leukemia/lymphoma):

    • Prior allogeneic stem-cell transplantation is excluded
    • Not a candidate for curative therapy or hematopoietic stem cell transplantation (either due to disease burden, fitness or preference)
    • Subjects must have relapsed or have had refractory DLBCL specifically for Phase 2
    • Subjects with HL: must be brentuximab vedotin refractory or intolerant
  • Subjects with histologically confirmed diagnosis of glioblastoma

    • Previous first-line treatment with at least radiotherapy and temozolomide
    • Documented first recurrence of glioblastoma by diagnostic biopsy or contrast enhanced magnetic resonance imaging (MRI) per RANO criteria
    • MRI within 14 days to start of study drug
    • An interval of at least 12 weeks after the end of prior radiation therapy
    • An interval of ≥21 days and full recovery from surgical resection prior to enrollment
  • 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
  • Females of child-bearing potential and males who use adequate birth control, from screening through 125 days after the last dose of study treatment
  • 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 unless directly resulting from the bone marrow infiltration of the underlying malignancy
  • Currently pregnancy or breastfeeding
  • Subjects who have received prior immune checkpoint inhibitors (eg, anti-CTLA-4, anti-PD-1, anti-PD-L1, and any other antibody or drug specifically targeting T-cell costimulation) or an IDO inhibitor. Subjects who have received experimental vaccines or other immune therapies should be discussed with the medical monitor to confirm eligibility

    o Anti-CTLA-4 given as first-line treatment for metastatic MEL will be permitted

  • Untreated central nervous system (CNS) metastases or CNS metastases that have progressed (eg, evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases)
  • Subjects with any active or inactive autoimmune process
  • Evidence of interstitial lung disease or active, noninfectious pneumonitis
  • Exclusion specific for subjects with unresectable or Stage IV MEL: Ocular MEL
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02327078

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

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
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
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
Study First Received: December 1, 2014
Last Updated: January 11, 2017

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

ClinicalTrials.gov processed this record on April 25, 2017