337 Bladder Cancer Clinical Trials Recruiting Now (May 2026): FGFR, TAR-210 MoonRISe, Nectin-4, TROP2 ADCs, Enfortumab Vedotin, Erdafitinib
Last updated: May 28, 2026
Current Clinical Trial Landscape
Active research areas in 2026:
- Enfortumab vedotin (ADC) + pembrolizumab as new first-line standard — replacing cisplatin-based chemo
- FGFR-targeted therapy (erdafitinib) for FGFR-altered tumors
- Novel ADCs: sacituzumab govitecan, sacituzumab tirumotecan, BL-B01D1, SHR-A2102
- Intravesical therapies for non-muscle-invasive bladder cancer (BCG alternatives)
- Neoadjuvant immunotherapy before radical cystectomy
Standard of care: Non-muscle-invasive (NMIBC): TURBT + intravesical BCG. Muscle-invasive (MIBC): neoadjuvant cisplatin-based chemo + radical cystectomy. Metastatic: enfortumab vedotin + pembrolizumab (first-line), or cisplatin/carboplatin + gemcitabine + avelumab maintenance.
Recruiting Trials by Disease Stage
Non-Muscle-Invasive Bladder Cancer (NMIBC)
BCG is standard but many patients are BCG-unresponsive. New intravesical and systemic options are being tested:
- BCG alternatives / additions (gene therapy, intravesical):
- NCT06510374 - ABLE-32: nadofaragene firadenovec (gene therapy) vs observation in intermediate-risk NMIBC (Phase 3, Ferring)
- NCT06545955 - ABLE-22: nadofaragene firadenovec ± BCG in BCG-naïve high-risk NMIBC (Phase 3, Ferring)
- FGFR-targeted intravesical delivery (TAR-210 / erdafitinib intravesical):
- NCT06319820 - MoonRISe-1: TAR-210 (erdafitinib intravesical delivery system) vs single-agent intravesical chemotherapy in intermediate-risk NMIBC with FGFR alterations (Phase 3, Janssen). First Phase 3 of an intravesical FGFR-targeted therapy.
- NCT06919965 - MoonRISe-3: TAR-210 vs intravesical chemotherapy in patients with intermediate-risk NMIBC (Phase 3, Janssen). Companion study to MoonRISe-1 with broader NMIBC population.
Muscle-Invasive Bladder Cancer (MIBC)
Neoadjuvant and perioperative immunotherapy trials — testing whether IO before/after surgery improves outcomes:
- Neoadjuvant / perioperative:
- NCT06960577 - Perioperative durvalumab + neoadjuvant ddMVAC or gemcitabine/cisplatin in MIBC (Phase 3, AstraZeneca). Extends the NIAGARA-style perioperative durvalumab regimen with chemotherapy backbone choice.
- NCT06879145 - SHR-A2102 (ADC) + tislelizumab in MIBC (Phase 2/3, Suzhou Suncadia)
- NCT07067749 - TEMPO-MIBC: MRI-guided treatment optimization for MIBC (Phase 3)
Locally Advanced or Metastatic Urothelial Carcinoma
Enfortumab vedotin + pembrolizumab is becoming standard first-line. New ADCs and combinations are being tested:
- Novel ADCs (Nectin-4, TROP2, B7-H3, HER2-expressing):
- NCT07129993 - Datopotamab deruxtecan (TROP2 ADC) + carboplatin or cisplatin vs gemcitabine/cisplatin in 1L advanced urothelial carcinoma (Phase 2/3, Daiichi Sankyo). First Phase 2/3 of a TROP2 ADC in 1L urothelial.
- NCT07419295 - Sacituzumab tirumotecan (Sac-TMT, MK-2870) for urothelial carcinoma (Phase 3, Merck) — another TROP2 ADC
- NCT06857175 - BL-B01D1 (EGFR×HER3 bispecific ADC) vs chemotherapy in recurrent/metastatic urothelial carcinoma (Phase 3, Sichuan Baili)
- NCT06738251 - SHR-A2102 (HER3 ADC) vs investigator's choice in advanced urothelial carcinoma (Phase 3, Shanghai Hengrui)
- NCT06196736 - 9MW2821 (Nectin-4 ADC) vs chemotherapy in previously treated urothelial carcinoma (Phase 3, Mabwell)
- IO combinations:
- NCT06524544 - Pembrolizumab + sacituzumab govitecan vs standard in metastatic UC (Phase 3)
Upper Tract Urothelial Carcinoma (UTUC)
A distinct subtype affecting the renal pelvis and ureter — fewer trials but growing interest:
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- NCT04574960 - NAUTICAL: Neoadjuvant treatment for upper tract invasive cancer (Phase 3)
- NCT04865939 - Gemcitabine vs water irrigation in upper tract urothelial carcinoma (Phase 3)
Showing selected notable trials. View all 337 recruiting interventional trials on ClinicalTrials.gov.
Frequently Asked Questions
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There are 337 recruiting interventional trials for bladder and urothelial cancer including ADCs (enfortumab vedotin), FGFR inhibitors (erdafitinib), checkpoint immunotherapy, intravesical therapies, and novel combinations.
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