Urothelial carcinoma
Also known as Uroepithelial carcinoma, transitional cell car. -uroth., transitional cell carcinoma of the urinary tract, transitional cell carcinoma of the urothelial tract.
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 5 clinical trials expected to report results, the earliest in Q1 2027.
- Q1 2027An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (IHC 1+ and Greater)
- Q4 2028Non-inferiority, Phase IV, Open-label, Randomized Controlled Trial of Vesical Imaging- Reporting and Data System (VI-RADS) Followed by Primary Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) Versus Conventional White-light TURBT Plus Repeated-TURBT (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs) Candidate for Second Look and Resection
- Q3 2029MAIN-CAV: Phase III Randomized Trial of Maintenance Cabozantinib and Avelumab vs Maintenance Avelumab After First-Line Platinum-Based Chemotherapy in Patients With Metastatic Urothelial Cancer
- Q2 2030The Phase III Adaptive Radiation and Chemotherapy for Muscle Invasive Bladder Cancer Trial (ARCHER)
- Q3 2030A Phase III Randomized Trial of Eribulin (NSC #707389) With Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy
Clinical MilestonesView all 13Hide
- 2026-06-24A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell CarcinomaResults posted
- 2026-03-20Duration of Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma: A Randomized Phase 3 Non-Inferiority Trial (IMAGINE)Results posted
- 2026-02-05A Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011)Results posted
- 2026-08-18The Phase III Adaptive Radiation and Chemotherapy for Muscle Invasive Bladder Cancer Trial (ARCHER)Results expected Q2 2030
- 2026-07-02A Phase III Randomized Trial of Eribulin (NSC #707389) With Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 TherapyResults expected Q3 2030
- 2026-06-15An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (IHC 1+ and Greater)Results expected Q1 2027
- 2026-06-12MAIN-CAV: Phase III Randomized Trial of Maintenance Cabozantinib and Avelumab vs Maintenance Avelumab After First-Line Platinum-Based Chemotherapy in Patients With Metastatic Urothelial CancerResults expected Q3 2029
- 2025-12-31Non-inferiority, Phase IV, Open-label, Randomized Controlled Trial of Vesical Imaging- Reporting and Data System (VI-RADS) Followed by Primary Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) Versus Conventional White-light TURBT Plus Repeated-TURBT (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs) Candidate for Second Look and ResectionResults expected Q4 2028
- 2032-01-01GU-216: A Pilot Study of Circulating Tumor DNA Adaptive Risk Maintenance Approach for Bladder Cancer (CARMA)Withdrawn
- 2028-11-01Phase II Trial of Lurbinectedin Combined With Avelumab as Switch Maintenance Firstline Therapy for Metastatic Urothelial Carcinoma With Stable or Responding Disease Following Platinum-based ChemotherapyWithdrawn
- 2026-06-24A Phase II Study of Adjuvant Nivolumab Switch From Intravenous (IV) to Subcutaneous (SC) Use in Participants With Resected Stage III or Stage IV Melanoma or High Risk Invasive Urothelial Carcinoma Originating in the BladderWithdrawn
- 2026-01-27A Single Arm, Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Avelumab in Combination With the ATR Inhibitor Tuvusertib in Participants With Advanced Urothelial Carcinoma That Has Progressed on Prior Anti-PD-(L)1 Therapy (JAVELIN DDRiver Bladder)Withdrawn
- 2032-01-01ClinicalGU-216: A Pilot Study of Circulating Tumor DNA Adaptive Risk Maintenance Approach for Bladder Cancer (CARMA)Withdrawn
- 2028-11-01ClinicalPhase II Trial of Lurbinectedin Combined With Avelumab as Switch Maintenance Firstline Therapy for Metastatic Urothelial Carcinoma With Stable or Responding Disease Following Platinum-based ChemotherapyWithdrawn
- 2026-08-18ClinicalThe Phase III Adaptive Radiation and Chemotherapy for Muscle Invasive Bladder Cancer Trial (ARCHER)Results expected Q2 2030
- 2026-07-02ClinicalA Phase III Randomized Trial of Eribulin (NSC #707389) With Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 TherapyResults expected Q3 2030
- 2026-06-24ClinicalA Phase II Study of Adjuvant Nivolumab Switch From Intravenous (IV) to Subcutaneous (SC) Use in Participants With Resected Stage III or Stage IV Melanoma or High Risk Invasive Urothelial Carcinoma Originating in the BladderWithdrawn
- 2026-06-24ClinicalA Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell CarcinomaResults posted
- 2026-06-15ClinicalAn Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (IHC 1+ and Greater)Results expected Q1 2027
- 2026-06-12ClinicalMAIN-CAV: Phase III Randomized Trial of Maintenance Cabozantinib and Avelumab vs Maintenance Avelumab After First-Line Platinum-Based Chemotherapy in Patients With Metastatic Urothelial CancerResults expected Q3 2029
- 2026-03-20ClinicalDuration of Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma: A Randomized Phase 3 Non-Inferiority Trial (IMAGINE)Results posted
- 2026-02-05ClinicalA Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011)Results posted
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approval — Balversa as monotherapy is indicated for the treatment of adult patients with unresectabl… (2024)
Approval — Urothelial carcinoma Tecentriq as monotherapy is indicated for the treatment of adul… (2017)
Approval — Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic… (2017)
Approval — Melanoma Opdivo as monotherapy or in combination with ipilimumab is indicated for the tr… (2015)
Approval — Melanoma Keytruda as monotherapy is indicated for the treatment of adults and adolescents… (2015)
Approval — Javlor is indicated in monotherapy for the treatment of adult patients with advanced or m… (2009)
Clinical trials
The current development programme across all trial phases.
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Associated genes
Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.
Disease biology
Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.
Reference
Authoritative identity, definition & identifiers.
Uroepithelial carcinoma, transitional cell car. -uroth., transitional cell carcinoma of the urinary tract, transitional cell carcinoma of the urothelial tract
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Related entities are derived from literature co-mention (studied together) — associative, not causal.