Nivolumab · Merkel Cell Carcinoma

Nivolumab is an anti–PD-1 monoclonal antibody.

Evidence (nivolumab):

Nivolumab was studied in a phase I/II trial (CheckMate 358 [NCT02488759]), published in abstract form, in patients with virus-associated cancers, including MCC. Patients may have received up to two prior lines of therapy. Patients with metastatic MCC were eligible regardless of MCPyV status or previous chemotherapy.[44,45]Nivolumab is not approved by the FDA for the treatment of MCC.

Source links and citations

Nivolumab was studied in a phase I/II trial (CheckMate 358 [NCT02488759]), published in abstract form, in patients with virus-associated cancers, including MCC. Patients may have received up to two prior lines of therapy. Patients with metastatic MCC were eligible regardless of MCPyV status or previous chemotherapy.[44,45]Nivolumab is not approved by the FDA for the treatment of MCC.

Data from 25 patients with metastatic disease demonstrated an overall response rate of 60% with a median treatment duration of 15.8 months. Preliminary results reported an ongoing response rate of 87%, with responses in 13 of 15 patients at last follow-up (median follow-up, 6 months).[44,45][Level of evidence C3]

Source links and citations

Nivolumab was studied in a phase I/II trial (CheckMate 358 [NCT02488759]), published in abstract form, in patients with virus-associated cancers, including MCC. Patients may have received up to two prior lines of therapy. Patients with metastatic MCC were eligible regardless of MCPyV status or previous chemotherapy.[44,45]Nivolumab is not approved by the FDA for the treatment of MCC.

This trial added a second cohort to investigate nivolumab plus ipilimumab (1 mg/kg) in patients with metastatic MCC.

Studies cited in this source section