In this study, patients with metastatic melanoma who have at least one injectable lesion that
has been refractory to PD-1 therapy (n=30 patients) will be enrolled. Cohort 1 will include
15 patients who progressed within 3 months (primary resistance) of starting PD-1 therapy and
cohort 2 will be patients who progressed after at least 3 months of PD-1 therapy. Patients
will receive up to 7 injections of PVSRIPO intra-lesionally in combination with Nivolumab.
Nivolumab will be administered according to the FDA-approved dosing schedule of 480 mg
intravenously every 4 weeks, beginning ~10 days after the first PVSRIPO infusion and will
continue for 4 cycles. Nivolumab may be continued up to 2 years per standard of care after
the completion of the PVSRIPO injections.
Phase:
Phase 1
Details
Lead Sponsor:
Darell Bigner Darell D. Bigner, MD, PhD
Collaborators:
Bristol-Myers Squibb Duke University Istari Oncology, Inc.