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

Incyte

Status and phase: Completed; Phase 2

Conditions: Metastatic Merkel Cell Carcinoma

Treatments: Drug: Retifanlimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03599713

INCMGA 0012-201

Details and patient eligibility

About

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

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

Retifanlimab: Chemotherapy: Naïve

Experimental group

Treatment:

Drug: Retifanlimab

Retifanlimab: Chemotherapy: Refractory

Experimental group

Treatment:

Drug: Retifanlimab