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A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
Trial ID: NCT03599713
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC).
A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma (POD1UM-201)
- 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
- Prior systemic therapy for MCC, including chemotherapy and prior PD-1 or
- 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
- 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
- Participant who is pregnant or breastfeeding.
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