Table 1.
Clinical Trials for Urothelial Carcinoma.
| Clinical Trial | Phase | Chemotherapy Type | Treatment Arms | Number of Patients | Disease Severity | Median Overall Survival Time (Hazard Ratio, 95% Confidence Interval, p-Value) | Median Progression Free Survival Time (Hazard Ratio, 95% Confidence Interval, p-Value) | Outcome | Status |
|---|---|---|---|---|---|---|---|---|---|
| IMvigor 211 | 3 | First-line | Atezolizumab + chemotherapy vs. chemotherapy | 931 | Locally advanced or metastatic urothelial cancer | 11.1 vs. 10.6 months (HR 0.87, 95% CI 0.63–1.21, p = 0.41) | N/A; not an outcome | Not significant | Active, not recruiting |
| IMvigor 130 | 3 | First-line | Atezolizumab + chemotherapy vs. chemotherapy + placebo | 1200 | Locally advanced or metastatic urothelial cancer | 16.0 months vs. 13.4 months (HR 0.83, 95% CI 0.69–1.00, p = 0.027, α = 0.007) | 8.2 months vs. 6.3 months (HR 0.82, 95% CI 0.70–0.96, p = 0.007) | Significant for improved PFS | Active, not recruiting |
| MK-3475-361/KEYNOTE-361 | 3 | First-line | Pembrolizumab + standard chemotherapy vs. pembrolizumab vs. standard chemotherapy | 1010 | Locally advanced or metastatic urothelial cancer | 17.0 vs. 14.3 months (HR 0.86, 95% CI 0.72–1.02, p = 0.0407, α = 0.0142) | 8.3 months vs. 7.1 months (HR 0.78, 95% CI 0.65–0.93, p = 0.0033, α = 0.0019) | Not significant | Active, not recruiting |
| NCT02603432 | 3 | Maintenance | Avelumab + supportive care vs. supportive care | 700 | Locally advanced or metastatic urothelial cancer who did not have disease progression with first-line chemotherapy | 21.4 vs. 14.3 months (HR 0.69, 95% CI 0.56–0.86, p = 0.001) | 3.7 months vs. 2.0 months (HR 0.62, 95% CI 0.52–0.75) | Significant for improved OS and improved PFS | Active, not recruiting |
| DANUBE | 3 | First-line | Durvalumab vs. durvalumab + tremelimumab vs. chemotherapy | 1032 | Locally advanced or metastatic urothelial cancer | 14.4 months (durvalumab alone) vs. 12.1 months (chemotherapy alone) (HR 0.89, 95% CI 0.71–1.11, p = 0.30) | 2.3 months vs. 3.7 months vs. 6.7 months (statistics not reported) | Not significant | Active, not recruiting |
| NILE | 3 | First-Line | Durvalumab + Chemotherapy and Durvalumab + Tremelimumab Chemotherapy vs. Chemotherapy alone | 1292 | Unresectable Locally Advanced or Metastatic Urothelial Cancer | No results posted yet | No results posted yet | No results posted yet | Recruiting |
| PEMBRO/EV | 3 | First-line | Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy | 860 | Untreated Locally Advanced or Metastatic Urothelial Cancer | Not reached | 12.3 months (95% CI: 8.0) | No results posted yet | Recruiting |
| CheckMate-032 | 1/2 | Second line with Urothelial | Nivolumab vs Nivolumab + Ipilimumab | 1131 (78 with UC) | Advanced or Metastatic Solid Tumors: 6 tumor types—triple-negative breast cancer, gastric cancer, pancreatic adenocarcinoma, small cell lung cancer, bladder cancer, and ovarian cancer | Urothelial: 9.9 months (95% CI, 7.3 to 21.1 months) in the NIVO3 arm, 7.4 months (95% CI, 5.6 to 11.0 months) in the NIVO3 + IPI1 arm, and 15.3 months (95% CI, 10.1 to 27.6 months) in the NIVO1 + IPI3 arm | Urothelial: 2.8 months (95% CI, 1.5 to 5.3 months) in NIVO3, 2.6 months (95% CI, 1.4 to 3.9 months) in NIVO3 + IPI1, and 4.9 months (95% CI, 2.7 to 6.6 months) in NIVO3 + IPI1 | N/A | Active, not recruiting |
| MORPHEUS | 1b/2 | Different lines of treatment | Multiple Immunotherapy-Based Treatments and Combinations (Atezolizumab, Enfortumab Vedotin, Niraparib, Hu5F9-G4, Tiragolumab, Sacituzumab Govitecan, Tocilizumab, Cisplatin, Gemcitabine) | 645 | GI Cancer, Urothelial Carcinoma, Melanoma | No results posted yet | No results posted yet | No results posted yet | Recruiting |
| EV-201 | 2 | Second-line | Enfortumab Vedotin | 219 | Locally advanced or metastatic urothelial carcinoma patients who were previously treated with ICIs | 14.7 months (95% CI 10.51–18.2) | 5.8 months (95% CI 5.03–8.28) | N/A | Active, not recruiting |
| TROPHY-U-01 | 2 | Third-Line | Sacituzumab Govitecan | 321 | Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors | 5.4 months (95% CI, 3.5 to 7.2 months) | 10.9 months (95% CI, 9.0 to 13.8 months) | Preliminary Data | Recruiting |
| CHECKMATE 901 | 3 | First-Line | Nivolumab + Ipilimumab or Chemotherapy vs. Chemotherapy Alone | 1307 | Untreated Inoperable or Metastatic Urothelial Cancer | No results posted yet | No results posted yet | No results posted yet | Recruiting |