OncoSec Medical announced enrollment has begun in a phase 2 trial, led by University of California, San Francisco, of the company’s ImmunoPulse IL-12 and Keytruda in patients with unresectable melanoma, according to a press release.
“There is increasing evidence that tumors need to be inflamed to have [tumor infiltrating lymphocytes] in order of anti–PD-1 therapies to be effective,” Mai H. Le, MD, chief medical officer of OncoSec, said in the release. “We anticipate that ImmunoPulse IL-12 will increase the proportion of patients who will respond to immune checkpoint inhibitors like Keytruda [pembrolizumab, Merck] and that the combination will have synergistic anti-tumor activity.”
ImmunoPulse IL-12 uses “intratumoral delivery of DNA-based IL-12 followed by electroporation,” the release stated.
Approximately 42 patients with unresectable “low tumor infiltrating lymphocyte” metastatic melanoma will be enrolled in the multicenter, open label trial, according to the release. Pembrolizumab will be administered once every 3 weeks, while ImmunoPulse IL-12 will be administered every 6 weeks on 3 separate days.
Best overall response rate of the combination therapy is primary endpoint. Safety and tolerability, duration of response, 24-week landmark progression-free survival, median progression-free survival and overall survival are other endpoints.