Biopharmaceutical firm OncoSec Medical has enrolled the first patient in its Phase II investigator sponsored trial, which is designed to assess the combination of ImmunoPulse IL-12 and anti-PD-1 agent Keytruda (pembrolizumab) for metastatic melanoma.
Sponsored by University of California, San Francisco (UCSF), the study will evaluate the anti-tumour activity, safety, and tolerability of the combination of OncoSec's investigational therapy ImmunoPulse IL-12 and Merck's approved anti-PD-1 agent Keytruda in patients with unresectable metastatic melanoma.
According to the firm, the primary endpoint of the trial is the best overall response rate (bORR) of the combination regimen in patients whose tumours are characterised by low numbers of tumour-infiltrating lymphocytes (TILs).
OncoSec president and CEO Punit Dhillon said: "This is the first study in the field of immuno-oncology to evaluate the combination of DNA-based interleukin-12 with electroporation and an anti-PD-1 / PD-L1 inhibitor.
"We believe the combination of OncoSec's intratumoral cancer immunotherapy and checkpoint inhibitors has the potential to be a powerful approach in the fight against cancer."
The company will enrol around 42 patients with unresectable low-TIL metastatic melanoma in the multi-centre, open label and single-arm trial.
In the study, patients will receive pembrolizumab systematically once every three weeks, while ImmunoPulse IL-12 will be administered on three separate days every six weeks.
The trial's key endpoints include bORR by RECIST v1.1 and immune related-Response Criteria (irRC), safety and tolerability, duration of response, 24-week landmark progression-free survival, median progression-free survival, and overall survival.
Image: Lymph node with almost complete replacement by metastatic melanoma. Photo: courtesy of Gabriel Caponetti.