Table 1.
Studies investigating anti-PD-1/PD-L1 combined with chemo- and/or radiotherapy in localized bladder cancer.
| NCT Number | Population | Timing | Phase | PD-1/PD-L1 | Addition | Endpoint(s) |
|---|---|---|---|---|---|---|
| NCT03294304 | T2-T4a N0 M0 MIBC | Neoadjuvant | 2 | Nivolumab | Gem/cis | pRR |
| NCT02690558 | T2-T4a N0 M0 MIBC | Neoadjuvant | 2 | Pembrolizumab | Gem/cis | pDS to < pT2 |
| NCT03406650 | T2-T4a N0-1 M0 | Neoadjuvant + adjuvant | 2 | Durvalumab | Gem/cis | EFS |
| NCT03661320 | T2-T4a N0 M0 | Neoadjuvant | 3 | Nivolumab | Gem/cis | pCRR, EFS |
| NCT03924856 | T2-T4a N0 M0 or T1-T4a N1 M0 | Neoadjuvant | 3 | Pembrolizumab | Gem/cis | pCRR, EFS |
| NCT03732677 | T2-T4a N0-1 M0 | Neoadjuvant + adjuvant | 3 | Durvalumab | Gem/cis | pCRR, EFS |
| NCT03558087 | T2-T4a N0 M0 | Neoadjuvant | 2 | Nivolumab | Gem/cis | CRR, pCRR |
| NCT04099589 | T2-T4a N0 M0 | Neoadjuvant | 2 | Toripalimab | Gem or cis | pCRR |
| NCT03674424 | T2-T4a Nx M0 | Neoadjuvant | 2 | Avelumab | Gem/cis or ddMVAC or paclitaxel + gemcitabine | pCRR |
| NCT02365766 | T2-T4a N0 M0 | Neoadjuvant | 1/2 | Pembrolizumab | Gem/cis or gemcitabine | AE, PalR |
| NCT04164082 | BCG-unresponsive | Neoadjuvant | 2 | Pembrolizumab | Gemcitabine hydrochloride | CRR, EFS |
| NCT02560636 | T2-T4a N0-3 M0-1 | Neoadjuvant | 1 | Pembrolizumab | Radiotherapy | MTD, AE |
| NCT02891161 | T2-T4a N0-2 M0 | Neoadjuvant | 2 | Durvalumab | Radiotherapy | DLT, PFS, DCR |
| NCT03950362 | BCG-unresponsive | Ineligible/refusal of RC | 2 | Avelumab | Radiotherapy | RFS |
| NCT03317158 | BCG-unresponsive | Neoadjuvant | 1/2 | Durvalumab | EBRT + BCG | Recommended dose, RFS |
| NCT03775265 | T2-4a N0 M0 | Bladder sparing | 3 | Atezolizumab | Gem or CIS or fluorouracil + MMC + radiotherapy | EFS |
| NCT02662062 | T2-T4a Nx M0 | Ineligible/refusal of RC | 2 | Pembrolizumab | Cisplatin + radiotherapy | AE (grade 3–4) |
| NCT02621151 | T2-T4a N0 M0 | Ineligible/refusal of RC | 2 | Pembrolizumab | Gemcitabine + radiotherapy | DFS |
| NCT03617913 | T2-T4a N0 M0 | Neoadjuvant | 2 | Avelumab | Flourouracil + MMC or cisplatin and radiotherapy | CRR |
| NCT03702179 | T2-T4a | Neoadjuvant | 2 | Durvalumab | Tremelimumab + radiotherapy | pRR |
| NCT03601455 | T2-T4a or N+/M+ | Ineligible for RC | 2 | Durvalumab | Tremelimumab + EBRT | AE, PFS |
| NCT03549715 | T2-T4a N0-1 M0 | Neoadjuvant | 1/2 | Durvalumab | Tremelimumab + ddMVAC | AE, pCRR |
AE = adverse events, DCR = disease control rate, ddMVAC = dose dense methotrexate vinblastine doxorubicin cisplatin, DFS = disease-free survival, DLT = dose limiting toxicity, EFS = event-free survival, EBRT = External Beam Radiotherapy, Gem/cis = gemcitabine/cisplatin, MMC = mitomycine C, MTD = maximum tolerated dose, PalR = pathologic muscle invasive response rate, p(C)RR = pathological (complete) response rate, pDS = pathological downstaging, PFS = progression-free survival, RFS = recurrence-free survival.