A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)



Status:Active, not recruiting
Conditions:Lung Cancer, Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/8/2018
Start Date:May 2, 2017
End Date:January 2020

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A Phase 1/2, Open-Label, Safety, Tolerability, and Efficacy Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)

This is an open-label, nonrandomized, Phase 1/2 study in subjects with advanced or metastatic
solid tumors. Phase 1 is an assessment to evaluate the safety and tolerability of epacadostat
when given in combination with pembrolizumab and chemotherapy. Once the recommended doses
have been confirmed, subjects with advanced or metastatic CRC, PDAC, NSCLC (squamous or
nonsquamous), UC, SCCHN or any advanced or metastatic solid tumor who progressed on previous
therapy with a PD-1 or PD-L1 inhibitor will be enrolled in Phase 2.


Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of selected advanced or metastatic
solid tumors.

- Presence of measurable disease per RECIST v1.1.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

- Laboratory and medical history parameters not within the Protocol-defined range.

- Receipt of anticancer medications or investigational drugs within the Protocol-defined
intervals before the first administration of study drug.

- Previous radiotherapy within 2 weeks of starting study therapy.

- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

- Has not recovered to ≤ Grade 1 from toxic effects of previous therapy and/or
complications from previous surgical intervention before starting study therapy.

- Receipt of a live vaccine within 30 days of planned start of study therapy.

- Active infection requiring systemic therapy.

- Subjects who have any active or inactive autoimmune disease or syndrome.

- Women who are pregnant or breastfeeding.
We found this trial at
16
sites
4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Principal Investigator: Kabir Mody
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Daniel Catenacci
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Matthew Taylor
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Houston, Texas 77030
Principal Investigator: Aung Naing, MD
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Houston, TX
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9801 Kincey Avenue
Huntersville, North Carolina 28078
Principal Investigator: John Powderly, MD
Phone: 704-947-6599
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3855 Health Sciences Drive
La Jolla, California 92093
Principal Investigator: Aaron Miller
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La Jolla, CA
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Los Angeles, California 90025
Principal Investigator: Samuel Klempner
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Los Angeles, CA
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1100 Charlotte Avenue
Nashville, Tennessee 37203
Principal Investigator: Johanna Bendell
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Nashville, TN
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1301 Medical Center Drive
Nashville, Tennessee 37232
Principal Investigator: Jordan Berlin
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Neil Segal
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Philadelphia, Pennsylvania 19104
Principal Investigator: Gregory Beatty
Phone: 215-220-9668
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Philadelphia, PA
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Phoenix, Arizona 85054
Principal Investigator: Tanios Bekaii-Saab
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5150 Centre Ave
Pittsburgh, Pennsylvania 15232
(412) 647-2811
Principal Investigator: James Lee, MD
University of Pittsburgh Cancer Institute Founded in 1985, the University of Pittsburgh Cancer Institute (UPCI)...
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Pittsburgh, PA
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Rochester, Minnesota 55905
Principal Investigator: Mahipal Amit
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Rochester, MN
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Andrea Wang-Gillam
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Principal Investigator: Ignacio Garrido Laguna, MD
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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