Phase 3 Trial to Compare PV-10 with Chemotherapy in Stage III Melanoma

“Recruitment will begin soon for a phase 3 trial that will compare intralesional PV-10 with chemotherapy in patients with stage IIIb or IIIc melanoma, according to a presenter at the HemOnc Today Melanoma and Cutaneous Malignancies meeting.

“The analysis will include 225 patients. Two-thirds will be randomly assigned to monthly injections with PV-10 (Provectus), a sterile, non-pyrogenic solution of rose bengal disodium that destroys tumors by necrosis. The other patients will be assigned standard-dose chemotherapy with dacarbazine or temozolomide.

“All patients must have cutaneous and subcutaneous disease with no active nodal disease, and all lesions must be BRAF wild type. All patients must be either refractory to or not candidates for systemic immunotherapy.

“ ‘This is a trial design that is difficult to do,’ Sanjiv S. Agarwala, MD, chief of oncology and hematology at St. Luke’s Cancer Center, professor at Temple University School of Medicine and a HemOnc Today Editorial Board member, said during a presentation. ‘We’re going to need a lot of centers, and there will be smaller groups per center because these are not easy patients to find. But we’re not going to deprive patients of the ability to get checkpoint inhibitors if that is the right treatment for them.’ ”