ANKTIVA Plus BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non… (NCT07551544) | Clinical Trial Compass
WithdrawnPhase 3
ANKTIVA Plus BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non-Muscle Invasive Papillary Bladder Cancer
Stopped: Sponsor decision
0Started 2026-05-15
Plain-language summary
This is an open-label, randomized, phase 3 study of intravesical BCG plus ANKTIVA (experimental arm) versus BCG alone (control arm) in participants who have histologically confirmed, BCG-naïve/BCG-exposed high-grade Ta/T1 papillary disease. The purpose of this study is to evaluate the contribution of effect of neoadjuvant ANKTIVA plus BCG experimental therapy in papillary NMIBC.
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
. Age ≥ 18 years.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
. Histologic confirmation of NMIBC of the urothelial carcinoma HG subtype (mixed histology tumors allowed if transitional cell histology is predominant histology), including histologically confirmed presence of HG Ta or T1 papillary disease only.
. No concurrent CIS at TURBT #1 during screening.
. Visually complete TURBT #1 per Investigator.
. BCG-naive disease, defined as either of the following:
. Have not received prior intravesical BCG; or
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.
. Previously received BCG but stopped receiving more than 3 years before date of randomization.
Exclusion criteria
. Life expectancy \< 2 years.
. BCG-unresponsive disease, defined as:
. Persistent or recurrent CIS (± recurrent Ta/T1 disease) within 12 months of receiving adequate BCG (at least 5 of 6 doses of an initial induction course plus either at least 2 of 3 doses of maintenance therapy or at least 2 of 6 doses of a second induction course); or
. Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG (at least 5 of 6 doses of an initial induction course plus either at least 2 of 3 doses of maintenance therapy or at least 2 of 6 doses of a second induction course); or
. T1 high-grade disease at the first evaluation following an induction BCG course alone (at least 5 of 6 doses of an initial induction course)
. Urinary tract infection or urinary retention.
. Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (that is, urethra, ureter, or renal pelvis/calyces). Ta/any T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization.
. Presence of any bladder or urethral anatomic feature (example, urethral stricture) that, in the opinion of the Investigator, may prevent the safe administration of intravesical N-803 or BCG. Participants with tumors involving the prostatic urethra in men will be excluded.