A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:August 30, 2018
End Date:February 2021
Contact:Incyte Corporation Call Center (US)
Email:medinfo@incyte.com
Phone:1.855.463.3463

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A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma

The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in
participants with metastatic merkel cell carcinoma (MCC).


Inclusion Criteria:

- Signed informed consent.

- Diagnosis of MCC with distant metastatic disease as a component of tumor burden and no
more than 3 prior systemic treatments, inclusive of systemic adjuvant therapy.

- Eastern Cooperative Oncology Group performance status of 0 to 1.

- Measurable disease according to RECIST v1.1.

- Availability of tumor tissue (fresh or archival) for central pathology review.

- Willingness to avoid pregnancy or fathering children based on protocol-defined
criteria.

Exclusion Criteria:

- Prior programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1
(PD-L1)-directed therapy.

- Treatment with anticancer drugs or participation in another interventional clinical
study within 21 days before the first administration of study drug.

- Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (with
the exceptions for anemia not requiring transfusion support and any grade of alopecia)
and/or complications from prior surgical intervention within 7 days before starting
study treatment.

- Radiation therapy administered within 2 weeks of first dose of study treatment or
radiation therapy in the thoracic region that is > 30 Gy within 6 months of the first
dose of study treatment.

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

- History of second malignancy within 3 years (with exceptions).

- Laboratory values outside the protocol-defined range at screening.

- Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.

- Active bacterial, fungal, or viral infections, including hepatitis A, B, and C.

- Receipt of a live vaccine within 90 days of planned start of study therapy.

- Current use of protocol-defined prohibited medication.

- Known hypersensitivity to another monoclonal antibody that cannot be controlled with
standard measures (eg, antihistamines and corticosteroids).

- Inability or unlikely, in the opinion of the investigator, to comply with the Protocol
requirements.

- Participant who is pregnant or breastfeeding.
We found this trial at
7
sites
Pittsburgh, Pennsylvania 15232
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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Fairfax, Virginia 22042
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Fairfax, VA
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Morgantown, West Virginia 26506
(304) 293-0111
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Morgantown, WV
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New Brunswick, New Jersey 08903
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New Brunswick, NJ
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Praha,
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Washington, District of Columbia 20007
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Washington,
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