Table 3.
Overview of selected neoadjuvant trials in MIBC testing chemo-immuntherapy combinations.
| Chemo-immunotherapy combinations | |||||
|---|---|---|---|---|---|
| Drugs | Number of patients | Study design | Primary endpoint | Status | Trial ID |
| Nivolumab + GC | 43 | Phase II Open Label Single arm |
pCR rate | Has results | NCT03294304 (BLTASST-1) |
| Nivolumab + GC | 76 | Phase II Open Label Single arm |
pCR rate 2 years MFS |
Active, not recruiting | NCT03558087 |
| Pembrolizumab + GC | 39 | Phase II Open Label Single arm |
pD rate (< pT2) |
Active, not recruiting | NCT02690558 |
| Pembrolizumab + GC or G | 83 | Phase I/II | Safety pMI-RR | Recruiting | NCT02365766 |
| Avelumab vs. Avelumab + MVAC vs. Avelumab + CG vs. Avelumab + PaG | 166 | II Open Label Single arm |
pCR rate | Recruiting | NCT03674424 (AURA) |
| Durvalumab + MVAC vs. Durvalumab + Tremelimumab + MVAC | 120 | I/II non-comparative, open-label |
pCR rate | Recruiting | NCT03549715 (NEMIO) |
ID, identification number; GC, gemcitabine, cisplatin; pCR, pathologic complete response; 2 yrs MFS: two years metastasis-free survival; pD, pathologic down-staging; G, gemcitabine; pMI-RR, pathologic muscle invasive response rate; MVAC, methotrexate, vinblastine, doxorubicin, and cisplatin; PaG, paclitaxel, gemcitabine.