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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Retifanlimab: Chemotherapy: Naïve
  • Drug: Retifanlimab
    INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks
    Other names:
    • MGA012
    • INCMGA00012
Experimental
Retifanlimab: Chemotherapy: Refractory
  • Drug: Retifanlimab
    INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks
    Other names:
    • MGA012
    • INCMGA00012

More Details

Status
Completed
Sponsor
Incyte Corporation

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.