Cretostimogene Grenadenorepvec for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Cretostimogene Grenadenorepvec for individuals with a specific type of bladder cancer that hasn't spread to the muscle. The trial aims to assess the safety and effectiveness of this treatment when administered directly into the bladder in various ways, with some groups also receiving an additional drug, gemcitabine. Suitable candidates have high-risk bladder cancer that has not responded well to previous treatments, such as BCG therapy, and have recently had all visible tumors removed. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that cretostimogene grenadenorepvec is generally well-tolerated by patients. Studies indicate it is safe for individuals with non-muscle invasive bladder cancer and works effectively, with many patients experiencing complete and lasting results. When combined with gemcitabine, a chemotherapy drug, both treatments appear safe and manageable.
As this is a Phase 2 trial, earlier studies have already tested cretostimogene grenadenorepvec, providing some confidence in its safety. However, all treatments can have side effects, which may vary among individuals. Participants should discuss any concerns with the trial team.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Cretostimogene Grenadenorepvec for bladder cancer because it uses a virus-based approach to deliver treatment directly to the cancer cells. Unlike conventional treatments like chemotherapy or surgery, this method involves injecting a genetically-modified virus into the bladder, which can potentially target and destroy cancer cells without harming healthy tissue. Additionally, some treatment arms combine this with gemcitabine, a chemotherapy drug, aiming to enhance effectiveness. This unique delivery method and combination therapy approach could offer new hope for patients with bladder cancer by providing a more targeted and potentially less toxic treatment option.
What evidence suggests that this trial's treatments could be effective for bladder cancer?
Research has shown that cretostimogene grenadenorepvec holds promise for treating high-risk non-muscle-invasive bladder cancer. In earlier studies, about 75.5% of patients achieved a complete response, meaning their cancer was undetectable after treatment. Among those who responded, 58% remained cancer-free for up to 24 months, indicating long-term effectiveness. The treatment also helped 84.5% of patients avoid major surgeries like bladder removal. In this trial, some participants will receive cretostimogene grenadenorepvec alone, while others will receive it with gemcitabine. When combined with gemcitabine, another cancer drug, the treatment showed a 2-year recurrence-free survival rate of 46%. This evidence suggests that cretostimogene grenadenorepvec, alone or with gemcitabine, could effectively manage this type of bladder cancer.678910
Who Is on the Research Team?
Pat Keegan
Principal Investigator
CG Oncology
Are You a Good Fit for This Trial?
This trial is for adults with high-risk bladder cancer that hasn't invaded muscle. They should not have had BCG treatment or only up to 2 doses in the last 24 months, and their tumors must be mostly urothelial with less than half being a different subtype. All visible cancer should be removed recently.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Cretostimogene and DDM are administered weekly for 6 weeks as an induction course
Reinduction Treatment
Reinduction course for patients with CIS and/or high-grade Ta disease at the 3-month evaluation
Maintenance Treatment
Maintenance treatment with three weekly treatments every three months during the first year, and every six months during the second year
Follow-up
Participants are monitored for disease status using urine cytology, cystoscopy, and other assessments every 3 months for the first 2 years, then every 6 months for a further 2 years
Optional Extension
Optional extension to the third year following the same six-month schedule as the second year
What Are the Treatments Tested in This Trial?
Interventions
- Cretostimogene Grenadenorepvec
Find a Clinic Near You
Who Is Running the Clinical Trial?
CG Oncology, Inc.
Lead Sponsor