Table 2.
Active Bacillus Calmette–Guérin unresponsive low-, intermediate-, and high-risk non-muscle invasive bladder cancer clinical trials ongoing within the United.
| Study Name | Study ID | Study Status | Study Size | Phase | NMIBC Risk | BCG Status | Therapeutic Agents |
|---|---|---|---|---|---|---|---|
| ADVANCED-2 | NCT05951179 | Recruiting | 102 | Phase Ib/II: Single Arm | High | Naïve, Unresponsive |
TARA-002 |
| BOND-003 | NCT04452591 | Recruiting | 110 | Phase III: Single-Arm | High | Unresponsive | CG0070, n-dodecyl-B-D-maltoside |
| CORE-001 | NCT04387461 | Active, not recruiting | 35 * | Phase II: Single-Arm | High | Unresponsive | CG0070, Pembrolizumab Injection, n-dodecyl-B-D-maltoside |
| CREST | NCT04165317 | Active, not recruiting | 1070 * | Phase III: Cohort 1: BCG-Naïve Arm A: PF-06801591 + BCG (induction+maintenance) Arm B: PF-06801591 + BCG (induction only) Arm C: BCG Cohort 2: BCG-Unresponsive Arm 1: BCG-Unresponsive CIS treated with PF-06801591 Arm 2: BCG-Unresponsive papillary-only disease treated with PF-06801591 |
High | Naïve, Unresponsive |
Sasanlimab |
| ENVISION | NCT05243550 | Active, not recruiting | 220 | Phase III: Single-Arm | High | ≤24 months, but not nonresponsive |
UGN-102 |
| J18158 | NCT03914794 | Recruiting | 43 | Phase II: Single-Arm | Low, Intermediate |
Unresponsive | Pemigatinib |
| KEYNOTE-057 | NCT02625961 | Recruiting | 320 | Phase II: Single-Arm Randomized | High | Unresponsive | Pembrolizumab, Pembrolizumab/vibostolimab, Favezelimab/pembrolizumab |
| SunRISe-1 | NCT04640623 | Recruiting | 200 | Phase II: Randomized Cohort 1: TAR-200 and Cetrelimab Cohort 2: TAR-200 Cohort 3: Cetrelimab Cohort 4: TAR-200 (Participants with Papillary Disease only) |
High | Unresponsive | TAR-200, cetrelimab |
| SunRISe-5 | NCT06211764 | Not recruiting yet | 250 | Phase III: Randomized Arm 1: TAR-200 Arm 2: MMC or Gemcitabine |
High | Unresponsive | TAR-200, Gemcitabine, Mitomycin C |
| THOR-2 | NCT04172675 | Active, not recruiting | 107 * | Phase II: Randomized Cohort 1: high-risk NMIBC presenting as papillary tumor only (CIS, absent) Arm1: Erdafitinib Arm 2: Investigators Choice Cohort 2: high-risk, BCG- unresponsive treated w/ Erdafitinib Cohort 3: intermediate-risk NMIBC presenting as a papillary disease only treated w/Erdafitinib |
High | Unresponsive | Erdafitinib, Gemcitabine, Mitomycin C |
| QUILT-3.032 | NCT03022825 | Recruiting | 190 | Phase II/III: Single Arm | High | Unresponsive | N-803 and BCG |
* Actual.