Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03022825 | QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 190 | — | — | Jun 2, 2017 | Mar 1, 2029 | Oct 16, 2025 | 28 | United States |
Cohort A \& Cohort C: Assess incidence of complete response of CIS (with or without Ta/T1 papillary disease) patients at any time
Cohort B: Assess disease-free rate at 12 months since first study treatment
| Arm | Type | Description |
|---|---|---|
| BCG+N-803 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| N-803 and BCG | DRUG | BCG and N-803 will be mixed together (with saline) and administered via intravesical instillation weekly for 6 consecutive weeks (induction). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36. |
| N-803 | DRUG | N-803 will be administered via intravesical instillation weekly for 6 consecutive weeks (induction). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36. |
Inclusion Criteria: * Male or female patients 18 years of age or older * Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology). * Histologically con...