A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
Trial Status: Active
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced / metastatic Merkel cell carcinoma (MCC).
- Signed informed consent.
- Diagnosis of MCC with distant metastatic disease or recurrent advanced locoregional disease not amendable to surgery or radiation and no more than 3 prior systemic treatments, inclusive of systemic adjuvant therapy.
- 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.
- Prior programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1 (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.
Stanford Cancer Institute Palo Alto
UCSF Medical Center-Mount Zion
Contact: UCSF Clinical Trials
University of Colorado Hospital
Hackensack University Medical Center
Rutgers Cancer Institute of New Jersey
Roswell Park Cancer Institute
University of Pittsburgh Cancer Institute (UPCI)
Fred Hutch / University of Washington Cancer Consortium
Trial Phase Phase II
Trial Type Treatment
- Primary ID INCMGA 0012-201
- Secondary IDs NCI-2018-01941
- Clinicaltrials.gov ID NCT03599713