ANKTIVA Plus BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non… (NCT07551544) | Clinical Trial Compass
Not Yet RecruitingPhase 3
ANKTIVA Plus BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non-Muscle Invasive Papillary Bladder Cancer
688 participantsStarted 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 range18 Years
SexALL
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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
✓. 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.