UC Davis Comprehensive Cancer Center is the first in its region to offer a clinical trial for bladder cancer patients, testing a novel treatment that could significantly improve outcomes for those with intermediate-risk non-muscle invasive bladder cancer (IR-NMIBC). The PIVOT-006 trial investigates the effectiveness of Cretostimogene grenadenorepvec in reducing cancer recurrence and improving survival rates.
Addressing Unmet Needs in Bladder Cancer Treatment
Many patients with IR-NMIBC experience cancer recurrence even after transurethral resection of the bladder tumor (TURBT) surgery. Regular monitoring through cystoscopy, involving the insertion of a tube into the urethra and bladder every 3-6 months, is necessary to check for new tumors. This new treatment offers hope for a more proactive approach.
Cretostimogene: A Targeted Viral Therapy
Cretostimogene grenadenorepvec is a specially engineered virus designed to target and kill cancer cells. It replicates within bladder cancer cells, triggering an anti-tumor response while sparing healthy cells. This mechanism of action differentiates it from traditional therapies and offers a potentially more effective and less toxic treatment option.
The PIVOT-006 Clinical Trial
The Phase 3 PIVOT-006 study is a randomized trial comparing the outcomes of patients receiving Cretostimogene therapy after surgery to those undergoing surgery alone. Led by Thenappan Chandrasekar, a urologist and associate professor with the Department of Urologic Surgery at UC Davis Health, the trial aims to determine if Cretostimogene can reduce recurrence and improve survival rates.
Potential Impact on Treatment Landscape
Historically, Bacille Calmette-Guerin (BCG), a tuberculosis vaccine, has been used to stimulate the immune system to attack bladder cancer cells. However, BCG has been in short supply due to manufacturing constraints, limiting its availability. Cretostimogene offers a potential alternative that could overcome these limitations.
"This could represent a major step forward in addressing the unmet medical needs of these patients," said Chandrasekar. "We are hopeful that this will allow us to do much more than monitor for recurrence, but actually give us a fighting chance to stop the cancer in its tracks."