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

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

  • Metastatic Merkel Cell Carcinoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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
Active, not recruiting
Sponsor
Incyte Corporation

Study Contact