384 Bladder Cancer Clinical Trials Recruiting Now (October 2026): FGFR, TAR-210 MoonRISe, Nectin-4, TROP2 ADCs, Enfortumab Vedotin, Erdafitinib

Last updated: October 28, 2026

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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Novel ADCs: sacituzumab govitecan (Trodelvy) — urothelial FDA indication voluntarily withdrawn by Gilead Apr 2025 after TROPiCS-04 missed its primary OS endpoint, but investigational trials remain active; sacituzumab tirumotecan, BL-B01D1, SHR-A2102
Intravesical therapies for non-muscle-invasive bladder cancer (BCG alternatives)
Neoadjuvant immunotherapy before radical cystectomy

Standard of care (updated October 2026): Non-muscle-invasive (NMIBC): TURBT + intravesical BCG; for BCG-naive high-risk NMIBC, durvalumab can be added to BCG (POTOMAC, FDA May 28, 2026; 32% lower risk of recurrence or death); for BCG-unresponsive disease, Anktiva (nogapendekin alfa inbakicept) + BCG now covers both carcinoma in situ and high-grade papillary-only tumors (expanded Oct 14, 2026); the gemcitabine intravesical system (Inlexzo) is approved for BCG-unresponsive disease with carcinoma in situ (Sep 2025); for recurrent low-grade intermediate-risk NMIBC, mitomycin intravesical solution (Zusduri, Jun 2025). Muscle-invasive (MIBC): perioperative enfortumab vedotin + pembrolizumab around radical cystectomy is now approved for all cystectomy candidates (KEYNOTE-B15/EV-304, FDA July 10, 2026; overall survival HR 0.65 vs neoadjuvant gemcitabine-cisplatin), alongside neoadjuvant cisplatin-based chemo + cystectomy; after cystectomy, adjuvant atezolizumab for patients whose ctDNA test shows molecular residual disease (IMvigor011, FDA May 15, 2026; overall survival 32.8 vs 21.1 months). Metastatic: enfortumab vedotin + pembrolizumab (first-line), nivolumab + gemcitabine-cisplatin (first-line, Mar 2024), or cisplatin/carboplatin + gemcitabine + avelumab maintenance; erdafitinib for FGFR3-altered disease after prior therapy (Jan 2024).

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)
- NCT07424287 - Intravesical SHR-1501 + BCG vs investigator-selected chemotherapy in non-muscle-invasive bladder cancer (Phase 3)
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 — active, not recruiting as of October 2026)
- 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)
- NCT05302284 - RC48-ADC (disitamab vedotin, HER2 ADC) + toripalimab in 1L HER2-expressing urothelial carcinoma (Phase 3)
IO combinations:
- NCT06524544 - Pembrolizumab + sacituzumab govitecan vs standard in metastatic UC (Phase 3) — investigational; the Trodelvy urothelial FDA indication was voluntarily withdrawn Apr 2025 after TROPiCS-04 missed its primary OS endpoint
- NCT07815665 - Ivonescimab (PD-1 × VEGF bispecific) + enfortumab vedotin (Nectin-4 ADC) in metastatic urothelial carcinoma (Phase 2/3)
FGFR-targeted (FGFR2/3 alterations):
- NCT07218380 - Vepugratinib (LY3866288, Lilly next-gen FGFR inhibitor) in urothelial cancer (Phase 3, activated 2026-06-24 — challenges erdafitinib as the FGFR-mutated 2L+ standard in the ~20% FGFR2/3-altered urothelial subset)

Upper Tract Urothelial Carcinoma (UTUC)

A distinct subtype affecting the renal pelvis and ureter — fewer trials but growing interest:

- 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 384 recruiting interventional trials on ClinicalTrials.gov.

Frequently Asked Questions

How do I find bladder cancer clinical trials I'm eligible for?

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What bladder cancer trials are currently recruiting?

There are 384 recruiting interventional trials for bladder and urothelial cancer in October 2026 including 49 Phase 3 studies. Recent Phase 3 entrants: nadofaragene firadenovec trials NCT06510374 + NCT06545955 (intravesical NMIBC), ctDNA-guided post-cystectomy IO NCT05987241, UGN-104 upper-tract urothelial NCT06774131, MEDI4736 durvalumab pre-surgery upper tract NCT04628767. Active classes: ADCs (enfortumab vedotin Nectin-4, sacituzumab govitecan TROP2, disitamab vedotin HER2), FGFR inhibitors (erdafitinib, TAR-210 MoonRISe), checkpoint immunotherapy, intravesical therapies, and novel combinations.

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