NCI-7848 was a single-arm, open-label Phase II study of REOLYSIN® monotherapy in patients with histologically confirmed metastatic melanoma. Patients were intravenously administered REOLYSIN® on days 1 through 5 of each twenty-eight day treatment cycle up to a maximum of 12 cycles, in the absence of disease progression or unacceptable toxicity. Approximately 23 patients were enrolled. The primary objectives of the trial were tumour response rate, clinical benefit rate (complete responses (CR) plus partial responses (PR)) and toxicity. The secondary objectives included progression-free survival, overall survival, and assessing viral replication in metastatic melanoma deposits.
Results from the study were published in the journal Molecular Therapy in August 2012. The treatment was reported to be well tolerated, without any dose reductions needing to be implemented. Of 21 response evaluable patients, post-treatment biopsy samples containing adequate tumour for correlative analysis were obtained for 13. Productive reoviral replication was demonstrated in two of these 13.
The study was sponsored by the US National Cancer Institute (NCI).