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 alter the management of 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), requiring frequent cystoscopies every 3-6 months to monitor for new tumors. This "watch and wait" approach can be stressful and highlights the need for more effective treatments.
Thenappan Chandrasekar, a urologist and associate professor with the Department of Urologic Surgery at UC Davis Health, is leading the PIVOT-006 clinical trial. He emphasized the potential of this trial to move beyond mere monitoring and actively combat the cancer.
Cretostimogene: A Targeted Viral Therapy
Cretostimogene grenadenorepvec is a specially engineered virus designed to selectively target and kill cancer cells. It replicates within bladder cancer cells, triggering an anti-tumor response while sparing healthy cells. This mechanism of action distinguishes it from traditional therapies and offers a potentially less toxic approach.
PIVOT-006 Trial Design and Potential Impact
The Phase 3 PIVOT-006 study is a randomized trial comparing the outcomes of patients who receive Cretostimogene therapy after surgery to those who undergo surgery alone. The trial aims to determine if the addition of Cretostimogene improves patient outcomes, offering a new treatment option for this challenging cancer.
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, limiting its availability to patients. Cretostimogene offers a potential alternative that could overcome these supply issues and provide a more reliable treatment option.
Chandrasekar noted the significance of this trial, stating, "This could represent a major step forward in addressing the unmet medical needs of these patients. 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."
