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

Trial ID or NCT#

NCT03599713

Status

not recruiting iconNOT RECRUITING

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).

Official Title

A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma (POD1UM-201)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.
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Investigator(s)

Sunil Arani Reddy
Sunil Arani Reddy
Medical oncologist, Cutaneous oncology specialist
Clinical Associate Professor, Medicine - Oncology

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Contact

Pham Phoung
650-725-9810

View on ClinicalTrials.gov