Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/12/2018
Start Date:April 13, 2017
End Date:March 2020
Contact:Incyte Corporation Call Center (US)
Email:medinfo@incyte.com
Phone:1.855.463.3463

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A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

The purpose of this study is to determine the safety, tolerability, and efficacy of
INCAGN01876 when given in combination with immune therapies in subjects with advanced or
metastatic malignancies.


Inclusion Criteria:

- Locally advanced or metastatic disease; locally advanced disease must not be amenable
to resection with curative intent.

- Phase 1: Subjects with advanced or metastatic solid tumors.

- Phase 1: Subjects who have disease progression after treatment with available
therapies.

- Phase 2: Subjects with advanced or metastatic cervical cancer, gastric cancer
(including stomach, esophageal, and GEJ), SCCHN, PD-1 refractory SCCHN and PD-1/PD-L1
relapsed melanoma.

- Presence of measurable disease based on RECIST v1.1.

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

Exclusion Criteria:

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

- Prior treatment with any tumor necrosis factor super family agonist.

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

- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.

- Active autoimmune disease.

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

- Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.

- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.

- Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).
We found this trial at
17
sites
Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Dr. Thomas George
Phone: 352-273-7832
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Dr. Carrie Lee
Phone: 919-966-0405
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Principal Investigator: Dr. John Thompson
Phone: 206-288-7051
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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166-174 Hawkesbury Road
Blacktown, New South Wales 2145
Principal Investigator: Dr. Bo Gao
Phone: +61 2 8670 5071
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7777 Forest Lane
Dallas, Texas 75230
Principal Investigator: Dr. Minal Barve
Phone: 214-658-1944
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Detroit, Michigan 48201
Principal Investigator: Dr. Anthony Shields
Phone: 313-576-9749
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Detroit, MI
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Dr. Martin Gutierrez
Phone: 551-996-5256
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Houston, Texas 77030
Principal Investigator: Dr. Vivek Subbiah
Phone: 713-794-1751
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Houston, TX
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Los Angeles, California 90025
Principal Investigator: Dr. Omid Hamid
Phone: 310-231-2121
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Nashville, Tennessee 37203
Principal Investigator: Dr. Johanna Bendell
Phone: 615-329-7413
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New York, New York 10065
Principal Investigator: Dr. Neil Segal
Phone: 646-888-4441
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Oklahoma City, Oklahoma 73104
Principal Investigator: Dr. Susana Ulahannan
Phone: 405-271-8001
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Oklahoma City, OK
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Philadelphia, Pennsylvania 19111
Principal Investigator: Dr. Anthony Olszanski
Phone: 215-214-1676
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4200 Fifth Avenue
Pittsburgh, Pennsylvania 15232
Principal Investigator: Dr. James Lee
Phone: 412-648-6586
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Portland, Oregon 97213
Principal Investigator: Dr. Rom Leidner
Phone: 503-215-7192
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Portland, Oregon 97213
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4960 Childrens Place
Saint Louis, Missouri 63110
Principal Investigator: Dr. Haeseong Park
Phone: 314-747-1864
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