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

• Status: Active, not recruiting
• Trial end date: 2023-09-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Antibodies

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.