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

Use our guide to learn which trials are right for you!

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
Houston, Texas 77030
1892
mi
from 98109
Houston, TX
Click here to add this to my saved trials
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...
2080
mi
from 98109
Birmingham, AL
Click here to add this to my saved trials
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...
1971
mi
from 98109
Nashville, TN
Click here to add this to my saved trials
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...
1026
mi
from 98109
Aurora, CO
Click here to add this to my saved trials
Austin, Texas 78705
1770
mi
from 98109
Austin, TX
Click here to add this to my saved trials
2329
mi
from 98109
Baltimore, MD
Click here to add this to my saved trials
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...
2485
mi
from 98109
Boston, MA
Click here to add this to my saved trials
Burlington, Massachusetts 01805
2475
mi
from 98109
Burlington, MA
Click here to add this to my saved trials
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...
2341
mi
from 98109
Durham, NC
Click here to add this to my saved trials
1504
mi
from 98109
Fairway, KS
Click here to add this to my saved trials
Fargo, North Dakota 58122
1194
mi
from 98109
Fargo, ND
Click here to add this to my saved trials
Los Angeles, California 90025
962
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90033
962
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
Manchester, M20 4BX
4623
mi
from 98109
Manchester,
Click here to add this to my saved trials
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...
1687
mi
from 98109
Milwaukee, WI
Click here to add this to my saved trials
New York, New York 10016
2402
mi
from 98109
New York, NY
Click here to add this to my saved trials
2400
mi
from 98109
New York, NY
Click here to add this to my saved trials
2301 East 60th Street North
North Sioux City, South Dakota 57104
1264
mi
from 98109
North Sioux City, SD
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15261
2131
mi
from 98109
Pittsburgh, PA
Click here to add this to my saved trials
Salt Lake City, Utah 84106
705
mi
from 98109
Salt Lake City, UT
Click here to add this to my saved trials
Salt Lake City, Utah 84112
702
mi
from 98109
Salt Lake City, UT
Click here to add this to my saved trials
San Francisco, California 94143
680
mi
from 98109
San Francisco, CA
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
2275
mi
from 98109
Winston-Salem, NC
Click here to add this to my saved trials