Table 2.
Ongoing trials on perioperative (radical cystectomy) systemic treatment.
| Drug | Type of Intervention | Condition | Phase | Status | Estimated Study Completion Date | Study Number |
|---|---|---|---|---|---|---|
| Atezolizumab | Neoadjuvant | MIBC in subjects appropriate for cystectomy and refusing or ineligible for neoadjuvant chemotherapy | 2 | Recruiting | 31 December 2021 | NCT02451423 |
| Bintrafusp alfa | Neoadjuvant | cT2-T4aN0-1M0 | 2 | Not yet recruiting | January 2025 | NCT04878250 |
| Gemcitabine, Avelumab and Carboplatin | Neoadjuvant | cT2-T4aN0M0 | 2 | Not yet recruiting | 30 April 2029 | NCT04871529 |
| Tislelizumab and Nab-Paclitaxel | Neoadjuvant | cT2-4aN1-3M0 | 2 | Recruiting | July 2024 | NCT04730219 |
| Retifanlimab or epacadostat or combination | Neoadjuvant | cT2-T3b, N0, M0 | 2 | Not yet recruiting | 30 June 2024 | NCT04586244 |
| Olaparib and Durvalumab or Durvalumab monotherapy | Neoadjuvant | cT2-T4aN0M0 or cT1-T4aN1M0, ineligibility for cisplatin chemotherapy | 2 | Not yet recruiting | December 2026 | NCT04579133 |
| Tislelizumab monotherapy or Tislelizumab + Gemcitabine and Cisplatin | Neoadjuvant | cT2-T4NxM1 and oligometastatic disease (solitary organ metastasis and ≤3 metastatic lesions and ≤5 cm metastasis diameter and no liver metastasis) | 2 | Recruiting | 1 December 2024 | NCT04570410 |
| Toripalimab and Gemcitabine | Neoadjuvant | Clinical stage II-IIIB, ineligibility for cisplatin chemotherapy | 2 | Recruiting | December 2023 | NCT04553939 |
| Gemcitabine and Cisplatin + Toripalimab | Neoadjuvant | cT2-4aN0M0 | 2 | Recruiting | 1 October 2022 | NCT04099589 |
| Dose dense MVAC with pegylated GCSF | Neoadjuvant | cT3-4a and N1-3 | 2 | Recruiting | 31 December 2021 | NCT04047693 |
| Durvalumab + GC or Durvalumab + Carboplatin Gemcitabine or Durvalumab + DD-MVAC |
Neoadjuvant | variant urothelial carcinoma histologies cT2-T4aN0-N1M0 |
2 | Recruiting | 13 August 2022 | NCT03912818 |
| Abemaciclib | Neoadjuvant | cT2-T4, pure or mixed histology urothelial carcinoma, ineligibility for cisplatin chemotherapy | 1 | Recruiting | February 2024 | NCT03837821 |
| Atezolimumab | Neoadjuvant | MIBC | - | Not yet recruiting | 31 May 2022 | NCT03577132 |
| Durvalumab + ddMVAC or Durvalumab + Tremelimumab + ddMVAC |
Neoadjuvant | MIBC | 1, 2 | Recruiting | September 2025 | NCT03549715 |
| Nivolumab + EBRT | Neoadjuvant | cT3/4 cN0/N+ M0 | 2 | Recruiting | August 2022 | NCT03529890 |
| Ipilimumab + Nivolumab | Neoadjuvant | cT3-4aN0M0 OR T1-4aN1-3M0 |
1 | Active, not recruiting | 1 September 2021 | NCT03387761 |
| Pembrolizumab | Adjuvant | pT2 and/or N+ | 3 | Recruiting | 1 June 2025 | NCT03244384 |
| Atezolizumab + GC | Neoadjuvant | cT2-4a;N0/X;M0 | 1, 2 | Active, not recruiting | December 2021 | NCT02989584 |
| Nivolumab or Nivolumab + Urelumab | Neoadjuvant | T2-T4N0-N2M0, subjects ineligible for or refusing cisplatin chemotherapy | 2 | Recruiting | March 2022 | NCT02845323 |
| Pembrolizumab | Neoadjuvant | T2-T4a N0 M0 | 2 | Recruiting | 27 December 2021 | NCT02736266 |
| Pembrolizumab + GC | Neoadjuvant | cT2-4aN0M0, ineligibility or eligibility for cisplatin chemotherapy | 1, 2 | Active, not recruiting | July 2024 | NCT02365766 |
ddMVAC—dose-dense methotrexate vinblastine doxorubicin cisplatin; GC—gemcitabine cisplatin.