Provectus to study novel drug combined with Keytruda for stage IV melanoma

Source: Healio.com/dermatology, September 2015

Provectus Biopharmaceuticals announced in a press release that it has completed protocol for a phase1b/2 testing of its investigational drug PV-10 in combination with Keytruda in patients with stage IV melanoma.

PV-10 is novel drug that is injected into solid tumors and is undergoing phase 3 testing for patients with stage III melanoma, according to the release. Keytruda (pembrolizumab, Merck) is an immune checkpoint inhibitor approved for treating patients with advanced or unresectable melanoma.

Clinical testing is expected to begin later this year, according to the release. The study’s phase 1b component will include 24 patients in a single arm, with endpoints measuring safety and efficacy. It will be used to support a larger, randomized phase 2 component.

The combination protocol study will allow initial clinical testing of concepts that are included in a patent held by Provectus, and jointly owned by Pfizer, according to the release. The patent covers using PV-10 in combination with systemic inhibitors of immune system down-regulation, including anti-CTLA-4, PD-1 and PD-L1 checkpoint antibodies.

“The primary endpoint of tolerability in the phase 1b portion of the study, combined with assessment of progression-free survival (PFS) and objective response rate (ORR) by RECIST criteria as key secondary endpoints, assessed over a 15-week treatment interval, establish a basis for determining whether to proceed to the larger, randomized phase 2 portion of the study,” Eric Wachter, PhD, chief technology officer of Provectus, stated in the release. “We will use an adaptive design for powering phase 2 based on preliminary results from phase 1, and estimate this portion of the study to require at least 120 subjects, with a primary endpoint of PFS and key secondary endpoint of ORR.”

Pembrolizumab will be administered every 3 weeks for up to 24 months in both portions of the study, with PV-10 administered concurrently for the first 15 weeks to all patients’ skin lesions, according to the release. Patients in the phase 1b trial will receive both drugs, while those in phase 2 will be randomly assigned PV-10 and pembrolizumab, or pembrolizumab alone.

Preliminary findings reported last year showed that the immunologic effects of tumor ablation with PV-10 may be complementary to immune checkpoint inhibition, according to the release.