Table 2.
Selected ongoing phase III trials of immune checkpoint inhibitors in urothelial carcinoma
| NCT Identifier Trial Name | Treatment arms | Design | Population | Notes | Status | Primary endpoint |
|---|---|---|---|---|---|---|
|
NCT02853305 KEYNOTE-361 |
(1) Pembrolizumab (2) Pembrolizumab + Chemo (3) Chemo |
RP III | (1) Metastatic (2) First line |
Chemo will be GC or GCa | Not yet open Accruing |
PFS OS |
|
NCT02632409 CheckMate 274 |
(1) Nivolumab (2) Placebo |
RP III PC |
Adjuvant | (1) Includes upper tract UC (2) PD-L1 status is not entry criteria |
DFS | |
|
NCT02603432 Javelin Bladder 100 |
(1) Avelumab + BSC (2) BSC |
RP III | (1) Metastatic (2) Maintenance |
Patients with SD or better after first-line chemo | Accruing | OS |
|
NCT02450331 IMvigor010 |
(1) Atezolizumab (2) Observation |
RP III | (1) MIBC Adjuvant (2) PD-L1 positive |
Does not include upper tract UC | Accruing | DFS |
|
NCT02807636 IMvigor130 |
(1) Atezolizumab + GCa (2) Placebo + GCa |
RP III PC |
(1) Metastatic (2) First line (3) Cisineligible |
Randomization is 2:1 | Accruing | OS PFS AEs |
|
NCT02302807 IMvigor211 |
(1) Atezolizumab (2) Chemotherapy |
RP III | (1) Metastatic (2) Postplatinum |
Investigator's choice in chemo arm: vinflunine, paclitaxel or docetaxel | Completed Accrual |
OS |
|
NCT02516241 DANUBE |
(1) Durvalumab + Tremelimumab(anti-CTLA-4 mAb) (2) Durvalumab (3) GC or GCa |
RP III | (1) Metastastic (2) First-line |
(1) PD-L1 status must be known but is not entry criteria (2) GC is cis-eligible. GCa if cisineligible |
Accruing | OS |
BSC = best supportive care; Chemo = chemotherapy; Cis = Cisplatin; DFS = disease free survival; GC = gemcitabine + cisplatin; GCa = gemcitabine + carboplatin; mAb = monoclonal antibody; MIBC = muscle-invasive bladder cancer; OS = overall survival; PC = placebo-controlled; PFS = progression free survival; RP III = randomized, phase III trial; SD = stable disease; UC = urothelial carcinoma.