Clinical Trial TitleA phase 2 study of INCMGA00012 in patients with metastatic merkel cell carcinoma.
Clinical Trial Protocol Description:
The purpose of this study is to investigate whether INCMGA00012 is safe and effective for treating patients with metastatic merkel cell carcinoma. Merkel cell carcinoma is an aggressive skin cancer that can spread rapidly to other areas of the body. In this study you and all other participants will receive INCMGA00012.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have a diagnosis of MCC with distant metastatic disease as a component of tumor burden and no more than 3 prior systemic treatments, inclusive of systemic adjuvant therapy.
- Have an ECOG performance status of 0 to 1.
- Have measurable disease according to RECIST v1.1.
- Are willing to avoid pregnancy or fathering children based on protocol-defined criteria.
You will be excluded from the study if any of the following criteria apply to you:
- Have received prior programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1 (PD-L1)-directed therapy.
- Have received treatment with anticancer drugs or participation in another interventional clinical study within 21 days before the first administration of study drug.
- Have 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.
- Have had radiation therapy administered within 2 weeks of first dose of study treatment or radiation therapy in the thoracic region that is > 30 Gy within 6 months of the first dose of study treatment.
- Have known central nervous system (CNS) metastases and/or carcinomatous meningitis.
This is a partial list of inclusion and exclusion criteria.