A new way of treating bladder cancer is expected to deliver promising results and the AdventHealth Cancer Institute is the only site in Florida, and the first in the U.S., to open this groundbreaking treatment, known as the INTerpath-005 V940 mRNA vaccine Phase II trial. The treatment became available in April and is aimed at revolutionizing treatment options for those battling this disease.
“This vaccine is precision medicine at its best,” said Dr. Guru Sonpavde, a medical oncologist and the medical director of genitourinary oncology at the AdventHealth Cancer Institute, as well as a member of the trial’s global steering committee. “Unlike most trials where all patients receive one specific drug, some of the patients in this trial will receive a new drug customized to target the specific mutated proteins only found in the cancer cells of that patient.”
This trial introduces a unique and innovative approach to combatting bladder cancer. This patient-customized mRNA vaccine, designed to activate the immune system against the unique proteins present in each individual's tumor, holds immense promise, Sonpavde said. With up to 34 neoantigens – or new mutated proteins encoded in the vaccine – it offers a tailored treatment against bladder cancer.
Participants will receive pembrolizumab (KEYTRUDA) combined with the new customized immunotherapy injection. KEYTRUDA alone has previously improved outcomes following surgical removal of aggressive muscle-invasive urothelial cancer.
“I am confident these two drugs will complement each other and kill cancer, therefore improving the cure rate of bladder cancer after it’s been removed,” said Dr. Sonpavde.
Participants receive the KEYTRUDA infusion every six weeks for one year and once the customized sequencing is complete, they get the V940 injection once every three weeks for nine doses, or for roughly six months.
Dr. Sonpavde sees this trial as a win-win for all participants because the other group that receives only KEYTRUDA, still gets a drug that physicians already know works and improves outcomes, instead of receiving a placebo.
"I’m optimistic the combination drug treatment, the V940 vaccine plus KEYTRUDA, in this trial will be safe and successful and will lead to a Phase III trial,” expressed Dr. Sonpavde. “From there, if benefit is confirmed, I envision this treatment to be more widely available worldwide in the near future, which is very exciting that we may soon be able to cure more patients.”
However, bladder cancer patients don’t have to wait years for access to this treatment. The trial can be accessed now through a physician referral and is available at AdventHealth in Orlando.
More information about becoming a participant in this trial can be discussed with the AdventHealth Clinical Research GU Coordinator at ORL.GU.ClinicalTrials@AdventHealth.com. There are eligibility requirements for this trial that offers, not just treatment, but a promise of a better future.
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