Danish-based biotechnology firm Bavarian Nordic has commenced a Phase II clinical trial of Prostvac (rilimogene) in combination with Yervoy (ipilimumab) and / or Opdivo (nivolumab) to treat localised prostate cancer patients.
Prostvac is a prostate specific antigen (PSA)-targeted immunotherapy candidate being developed to induce the body's immune response to target and destroy prostate cancer cells.
Ipilimumab and nivolumab are immune checkpoint inhibitors developed and marketed by Bristol-Myers Squibb (BMS).
The first stage of the trial will assess the safety of the combination of three drugs in ten castration-resistant prostate cancer patients.
The trial will then recruit three cohorts of approximately 55 localised prostate cancer patients who will be administered with Prostvac + ipilimumab or Prostvac + nivolumab combination, or a combination of all three drugs before the radical prostatectomy.
Bavarian Nordic president and CEO Paul Chaplin said: "There are now eleven ongoing studies of Prostvac across various stages of prostate cancer.
"We are excited to learn more about the potential of Prostvac for treating this population, and to evaluate the potential synergistic effects of combining the vaccine with checkpoint inhibitors, as we believe Prostvac may enhance the clinical activity of these drugs."
The trial's primary endpoint is to examine and compare changes in T-cell infiltration within the tumour following the neoadjuvant treatment across the three cohorts.
The Phase II trial is the second trial being conducted in collaboration with BMS, while the first Phase I trial assessed the Prostvac + ipilimumab combination in metastatic castration-resistant prostate cancer (mCRPC) patients.
Prostvac is currently being developed in collaboration with the Center for Cancer Research, a part of the intramural research programme of the National Cancer Institute under a cooperative research and development agreement.