A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)

Completed · Phase 2

Conditions studied: Metastatic Merkel Cell Carcinoma

In brief

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

Key facts

Study ID

NCT03599713

Run by

Incyte Corporation

People needed

107

Starts

2019-02-25

Expected to finish

2024-06-28

Last updated by the study team

2025-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent.
• Diagnosis of MCC with distant metastatic disease or recurrent, advanced locoregional disease not amenable to surgery or radiation
• 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.

You may not qualify if…

• Prior systemic therapy for MCC, including chemotherapy and prior PD-1 or 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 to 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 28 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.

Where it is running

• University of California San Francisco Comprehensive Cancer Center — San Francisco, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Rush University — Chicago, Illinois, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• John Theurer Cancer Center, Hackensack University Medical Center — Hackensack, New Jersey, United States
• Rutgers Cancer Institute of Nj — New Brunswick, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• Upmc Cancercenter — Pittsburgh, Pennsylvania, United States
• Inova Fairfax Hospital — Fairfax, Virginia, United States
• University of Washington - Seattle Cancer Care Alliance — Seattle, Washington, United States
• West Virginia University Hospitals Inc — Morgantown, West Virginia, United States
• St Vincent'S Hospital Sydney — Darlinghurst, New South Wales, Australia
• Cross Cancer Institute — Edmonton, Alberta, Canada
• Tom Baker Cancer Centre — Calgary AB, CA, Canada
• London Health Sciences Centre Lhsc - South Street Hospital — London, Ontario, Canada
• Sir Mortimer B. Davis Jewish General Hospital Segal Cancer Ctr — Montreal, Quebec, Canada
• McGill University Health Centre/Glen Site/Cedars Cancer Centre — Montreal, Quebec, Canada
• Fakultni Nemocnice Olomouc — Olomouc, Czechia
• Prof Mudr Petr Arenberger Drsc Mba — Prague, Czechia
• Nemocnice Na Bulovce — Prague, Czechia
• Stanford Cancer Institute — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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