A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)



Status:Active, not recruiting
Conditions:Lung Cancer, Colorectal Cancer, Skin Cancer, Ovarian Cancer, Cancer, Brain Cancer, Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/7/2018
Start Date:November 2014
End Date:October 2020

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A Phase 1/2 Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)

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).


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
We found this trial at
23
sites
2301 East 60th Street North
North Sioux City, South Dakota 57104
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1802 6th Avenue South
Birmingham, Alabama 35294
(205) 934-4011
UAB Comprehensive Cancer Center One of the nation’s leading cancer research and treatment centers, the...
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Birmingham, AL
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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13001 E 17th Pl
Aurora, Colorado 80045
(303) 724-5000
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
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Aurora, CO
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Austin, Texas 78705
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Austin, TX
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Baltimore, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Burlington, Massachusetts 01805
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Burlington, MA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Fairway, KS
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Fargo, North Dakota 58122
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Fargo, ND
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Houston, Texas 77030
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Houston, TX
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Los Angeles, California 90025
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Los Angeles, CA
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Los Angeles, California 90033
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Los Angeles, CA
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Manchester, M20 4BX
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Manchester,
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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New York, New York 10016
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Pittsburgh, Pennsylvania 15261
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Salt Lake City, Utah 84106
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Salt Lake City, Utah 84112
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San Francisco, California 94143
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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