Safety and Efficacy of CG0070 Oncolytic Virus Regimen in Patients With High Grade Non-Muscle Inva… (NCT02143804) | Clinical Trial Compass
WithdrawnPhase 2
Safety and Efficacy of CG0070 Oncolytic Virus Regimen in Patients With High Grade Non-Muscle Invasive Bladder Cancer
Stopped: Change in trial design
United States0Started 2014-03
Plain-language summary
This is an expanded access protocol to study the safety and efficacy of CG0070 in Cis and Cis with Ta and/or T1 disease patients who failed both BCG therapy and the BOND protocol (NCT 01438112), or in high grade Ta and T1 patients who failed BCG therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients who were first enrolled in the BOND protocol but have failed to achieve a complete response or have relapsed following a complete response at 3 months after receiving control treatments
. OR patients who were first enrolled in the BOND protocol but have relapsed following a complete response lasting over a year after receiving CG0070 treatments
. OR patients who have Ta/T1 high grade, refused cystectomy and are CG0070 naïve
. OR patients from the exBOND protocol who experienced a tumor relapse with no disease progression after sustaining 12 months or longer complete response duration
. Tumor must be considered unresectable or with residual disease.
. Patients must be declared as medically unfit for cystectomy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Durable Complete Response Proportion
Timeframe: 15 month time point from the date of the first intravesical treatment and/or at least 12 months from the initial complete response assessment (3 months from first intravesical treatment) or any time after
. No disease progression from disease status at the beginning of the BOND trial.
. They must have also received at least one prior course of BCG therapy per the recommended schedules. Patients can have either failed BCG induction therapy within a six-month period or have been successfully treated with BCG, but subsequently found to have recurrence. The standard course of intravesical BCG therapy must include at least six weekly treatments (allowable range of instillations per course is 4-9) within a six-month period