A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Signed informed consent. 
  • 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. 
  • 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 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 in 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 90 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 (e.g., antihistamines and corticosteroids).
  • Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements. 
  • Participant who is pregnant or breastfeeding.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yiyi Yan, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.

Mayo Clinic Footer