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Home › Conditions › urothelial carcinoma

Urothelial carcinoma

Part of Cancer

16 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for urothelial carcinoma

39 trials tracked for urothelial carcinoma: 5 in phase 3 or 4 and 4 with published results. The most-cited published study has 786 citations.

39Trials tracked
5Phase 3 & 4
0Recruiting
4With published results
Phase distribution
Phase 3 5 Phase 2 26 Phase 1 6 Other / NA 2
  1. Phase 3 Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Completed · 786 cited
  2. Phase 3 A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer Completed · 171 cited
  3. Phase 3 Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011) Completed · 81 cited
  4. Phase 3 Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer Completed · 58 cited
  5. Phase 3 Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC) Completed
  6. Phase 2 Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors Completed
Show 33 more trials
  1. Phase 2 Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma Completed
  2. Phase 2 Evaluation of NanoDoce® in Participants With Urothelial Carcinoma Completed
  3. Phase 2 Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy Completed
  4. Phase 2 Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Urothelial Bladder Cancer Completed
  5. Phase 2 Trial of Tremelimumab in Patients With Previously Treated Metastatic Urothelial Cancer Completed
  6. Phase 2 First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma Completed
  7. Phase 2 Phase II Trial of Gemcitabine, Carboplatin, and Bevacizumab in Chemotherapy Naive Patients With Advanced/Metastatic Urothelial Carcinoma Completed
  8. Phase 2 Phase 1/2 Study of APR-246 in Combination With Pembrolizumab in Subjects With Solid Tumor Malignancies Completed
  9. Phase 2 A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors Completed
  10. Phase 2 A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer Completed
  11. Phase 2 Abraxane With Anti-PD1/PDL1 in Patients With Advanced Urothelial Cancer Completed
  12. Phase 2 Trial of EP0057, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer Completed
  13. Phase 2 Neoadjuvant Pembrolizumab in Combination With Gemcitabine Therapy in Cis-eligible/Ineligible UC Subjects Completed
  14. Phase 2 Trial of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma Completed
  15. Phase 2 Derazantinib and Atezolizumab in Patients With Urothelial Cancer Completed
  16. Phase 2 Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers Completed
  17. Phase 2 Phase 2 Study of Docetaxel +/- OGX-427 in Patients With Relapsed or Refractory Metastatic Bladder Cancer Completed
  18. Phase 2 A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer Completed
  19. Phase 2 Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations Completed
  20. Phase 2 TRC105 in Adults With Advanced/Metastatic Urothelial Carcinoma Completed
  21. Phase 2 Testing the PD-1 Inhibitor Pembrolizumab as Maintenance Therapy After Initial Chemotherapy in Metastatic Bladder Cancer Completed
  22. Phase 2 Cabozantinib for Advanced Urothelial Cancer Completed
  23. Phase 2 Atezolizumab and CYT107 in Treating Participants With Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma Completed
  24. Phase 2 A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors Completed
  25. Phase 2 Cabozantinib Plus Pembrolizumab as First-Line Therapy for Cisplatin-Ineligible Advanced Urothelial Carcinoma Completed
  26. Phase 1 SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas Completed
  27. Phase 1 Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma Completed
  28. Phase 1 A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors Completed
  29. Phase 1 Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer Completed
  30. Phase 1 Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer Completed
  31. Phase 1 Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors Completed
  32. N/A A NON-INTERVENTIONAL STUDY ON AVELUMAB USE IN PATIENTS WITH ADVANCED OR METASTATIC UROTHELIAL CARCINOMA Completed
  33. N/A A Study to Learn About the Study Medicine (Avelumab) in Japanese Patients With Urothelial Carcinoma That Has Spread Completed

Showing the 39 most-cited and recently-updated of 39 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Urothelial carcinoma: what the trials found

Atezolizumab in combination with chemotherapy (Gemcitabine and Carboplatin/Cisplatin) demonstrated a statistically significant improvement in progression-free survival (PFS) compared to placebo plus chemotherapy (8.18 vs 6.34 months, p=0.0073) and a statistically significant improvement in overall survival (OS) (16.13 vs 13.44 months, p=0.0230). However, Atezolizumab monotherapy did not show a statistically significant difference in OS compared to the placebo plus chemotherapy arm (p=0.3968).

Ramucirumab showed a statistically significant improvement in progression-free survival (PFS) of 4.07 months versus 2.76 months (p=0.0118), though it did not reach statistical significance for overall survival (OS) (p=0.2461). The objective response rate (ORR) was 25.9% with Ramucirumab compared to 13.9% in the control group.

Pembrolizumab has been evaluated across multiple trials; one study showed no significant difference in PFS or OS compared to standard controls 4, while another trial reported a median of 83 patients achieving relapse-free survival (RFS) at 18 months and an OS of 71.9% at 5 years 9. In a smaller cohort, Pembrolizumab showed an ORR of 18% with 3 patients achieving a complete response 11.

Bevacizumab was evaluated for safety and efficacy; while it did not show a statistically significant difference in OS compared to its control (14.5 vs 14.3 months, p=0.1707), the trial recorded 163 patients experiencing Grade 3+ toxicity 5. Atezolizumab monotherapy was also evaluated in a smaller study where ORR and Clinical Benefit Rate (CBR) did not reach statistical significance 13.

A small-scale study of UGN-101 reported consistent scores for the Post-instillation Patient Questionnaire across all measured points 6.

Recent results — preliminary, needs further review

  • Avelumab was evaluated in a large cohort (N=596) where 345 participants experienced Grade 3, 4, or 5 adverse events; results also included assessments of the FACT FBlSI-18 bladder symptom index over 24 weeks 1.
  • EP0057 (CLRX101) in combination with Olaparib was evaluated in a small cohort for progression-free survival rates at 16 weeks 7.

For the clinician treating this condition

  • Atezolizumab combined with Gemcitabine and Carboplatin/Cisplatin significantly improves both PFS and OS compared to chemotherapy alone.
  • Ramucirumab provides a statistically significant improvement in progression-free survival (PFS) over its control arm.
  • Pembrolizumab shows varying results across different trial sizes, including reported improvements in relapse-free survival and objective response rates.

AI synthesis of 8 cited trials, updated Jun 21, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Erdafitinib improves overall survival in FGFR3-altered urothelial carcinoma with HR 0.64 compared to chemotherapy
Oncology RCT
Erdafitinib improves overall survival in FGFR3-altered urothelial carcinoma with HR 0.64 compared to chemotherapy Trial shows erdafitinib improves survival for specific bladder cancers
In a randomized controlled trial of 266 patients with locally advanced or metastatic urothelial carcinoma and susceptible FGFR3 alterations,…
A new treatment called erdafitinib showed improved survival for patients with specific genetic markers in advanced urothelial carcinoma.
Oct 16, 2026
PD-L1 and CTLA-4 Variants Linked to Genitourinary Cancer Risk
Oncology Meta-analysis
PD-L1 and CTLA-4 Variants Linked to Genitourinary Cancer Risk Genetic variations linked to risk of certain genitourinary cancers
A meta-analysis of 16 studies links PD-L1 and CTLA-4 variants to altered genitourinary cancer susceptibility, especially in Asian population…
Specific genetic markers in the PD-L1 and CTLA-4 genes are linked to different levels of risk for bladder, kidney, and prostate cancers.
Oct 16, 2026
Enfortumab vedotin cutaneous toxicity and peripheral neuropathy are associated with improved outcomes in urothelial carcinoma
Urology Meta-analysis
Enfortumab vedotin cutaneous toxicity and peripheral neuropathy are associated with improved outcomes in urothelial carcinoma Skin Reactions and Nerve Issues Linked to Better Survival
This meta-analysis evaluates the association between enfortumab vedotin-related adverse events and clinical outcomes in patients with advanc…
A review of patients with advanced urothelial carcinoma suggests that certain side effects from enfortumab vedotin may link to improved surv…
Oct 4, 2026
Intravesical drug delivery systems improve urothelial drug deposition and allow repurposing of systemic agents
Oncology Sys. Review
Intravesical drug delivery systems improve urothelial drug deposition and allow repurposing of systemic agents New Delivery Methods May Improve Treatment for Bladder Cancer
This mini review examines intravesical drug delivery systems, including mucoadhesive and targeted platforms, for non-muscle-invasive bladder…
New delivery systems for bladder cancer drugs could help medicine stay in the bladder longer and target cancer cells more effectively.
Frontiers Sep 30, 2026
ADC resistance in bladder cancer is multifactorial, review finds, with no validated overcoming strategy
Drug Pipeline Sys. Review
ADC resistance in bladder cancer is multifactorial, review finds, with no validated overcoming strategy New research identifies why some bladder cancer drugs stop working
This systematic review examines mechanisms of resistance to antibody-drug conjugates in locally advanced or metastatic urothelial carcinoma.…
Doctors are uncovering the complex reasons why certain bladder cancer treatments lose their power, helping pave the way for more precise the…
Frontiers Sep 13, 2026
Disitamab vedotin and tislelizumab combination achieved remission of skin metastasis in a patient with bladder carcinoma
Orthopedics & Sports Medicine Sys. Review
Disitamab vedotin and tislelizumab combination achieved remission of skin metastasis in a patient with bladder carcinoma Drug Combo Clears Skin Metastasis in Bladder Cancer
This case report describes a 70-year-old man with muscle-invasive bladder carcinoma treated with a combination of disitamab vedotin and tisl…
A man's bladder cancer skin spread vanished after a two-drug combo, but it's just one case.
Frontiers Sep 4, 2026
Targeted cytokine delivery platforms in canine oncology provide data for human immuno-oncology dose selection
Allergy & Immunology Sys. Review
Targeted cytokine delivery platforms in canine oncology provide data for human immuno-oncology dose selection Cytokine Therapies Show Potential for Treating Canine Cancers
This mini review synthesizes evidence on targeted cytokine delivery platforms, such as IL-12 and IFN-beta, in dogs with various spontaneous …
New research explores how targeted cytokine delivery systems can treat various cancers in dogs and provide data for future human cancer trea…
Frontiers Jul 6, 2026
Systematic review of preclinical CBD effects in canine cancers
Cardiology Meta-analysis
Systematic review of preclinical CBD effects in canine cancers Lab tests suggest CBD may help treat cancer in dogs
This is a systematic review of preclinical studies on cannabidiol for canine cancers. It synthesizes evidence of antiproliferative and proap…
Lab tests suggest CBD may help treat cancer in dogs by slowing growth and triggering cell death, though human use remains unproven.
Frontiers May 22, 2026
FDA approves OPDIVO QVANTIG for multiple advanced cancer indications including renal cell carcinoma and melanoma
Oncology FDA Approval
FDA approves OPDIVO QVANTIG for multiple advanced cancer indications including renal cell carcinoma and melanoma FDA approves subcutaneous nivolumab combination for multiple advanced cancers
This FDA approval document grants authorization for OPDIVO QVANTIG, a subcutaneous combination of nivolumab and hyaluronidase, for specified…
The FDA has approved a new subcutaneous form of nivolumab for several advanced cancers, offering a more convenient treatment option for elig…
FDA May 15, 2026
Early time-of-day immune checkpoint inhibitor administration improves overall survival in advanced solid tumors
Oncology Meta-analysis
Early time-of-day immune checkpoint inhibitor administration improves overall survival in advanced solid tumors Cancer Patients Live Longer When Immunotherapy Starts Early in Day
This systematic review and meta-analysis evaluated 6129 patients with advanced solid tumors receiving immune checkpoint inhibitors. Earlier …
• Morning immunotherapy shots link to longer survival for advanced cancers • Helps patients fighting lung stomach kidney and other tough can…
May 5, 2026
Systematic review and meta-analysis of disitamab vedotin efficacy in urothelial carcinoma
Urology Meta-analysis
Systematic review and meta-analysis of disitamab vedotin efficacy in urothelial carcinoma Researchers Find Disitamab Vedotin Shows Activity In Bladder Cancer
This systematic review and meta-analysis evaluates disitamab vedotin-based therapy in HER2-negative and HER2-low locally advanced or metasta…
A new review suggests the drug disitamab vedotin might work for some bladder cancer patients with low or negative HER2 levels.
May 1, 2026
Disitamab vedotin plus PD-1 inhibitor showed high response rates in urothelial carcinoma patients across six centers
Allergy & Immunology Cohort
Disitamab vedotin plus PD-1 inhibitor showed high response rates in urothelial carcinoma patients across six centers New Drug Combo Shows Strong Results for Advanced Bladder Cancer
This retrospective cohort study evaluated disitamab vedotin combined with a PD-1 inhibitor in 132 patients with locally advanced or metastat…
A new drug pairing shrank tumors in 71% of advanced bladder cancer patients, even those with diabetes or kidney problems.
Frontiers Apr 29, 2026

Research across Cancer

Related studies from across the Cancer family.

Preoperative inflammatory biomarkers SIRI and NLR associate with worse survival in UTUC after RNU
Oncology Meta-analysis
Preoperative inflammatory biomarkers SIRI and NLR associate with worse survival in UTUC after RNU Inflammatory Biomarkers Linked to Outcomes in Upper Tract Urothelial Carcinoma
This systematic review and meta-analysis of 7,346 patients found that preoperative systemic inflammatory biomarkers, specifically SIRI (HR 2…
Specific inflammatory markers in the blood may be linked to survival outcomes for patients with upper tract urothelial carcinoma.
Frontiers Jul 30, 2026
Liquid biopsy guides kidney-sparing decisions in upper tract urothelial carcinoma without replacing standard care
Urology Sys. Review
Liquid biopsy guides kidney-sparing decisions in upper tract urothelial carcinoma without replacing standard care Liquid biopsy helps doctors decide on kidney-sparing care for upper tract urothelial carcinoma
This review discusses liquid biopsy-guided kidney-sparing management for patients with upper tract urothelial carcinoma. The authors note th…
A review shows liquid biopsy adds value to kidney-sparing decisions for upper tract urothelial carcinoma but does not replace standard imagi…
Frontiers Jun 3, 2026
Metachronous non-muscle invasive bladder cancer after UTUC has worse recurrence and progression with BCG than primary disease
Urology Meta-analysis
Metachronous non-muscle invasive bladder cancer after UTUC has worse recurrence and progression with BCG than primary disease Doctors found that bladder cancer returning later has higher risk of coming back again
This systematic review and meta-analysis of 1292 patients found that metachronous non-muscle invasive bladder cancer after upper tract uroth…
A large review shows bladder cancer returning after a previous kidney cancer treatment is more likely to grow back. This group also has a lo…
Jun 1, 2026
Systematic review of extended versus standard pelvic lymph node dissection in bladder cancer surgery
Oncology Sys. Review
Systematic review of extended versus standard pelvic lymph node dissection in bladder cancer surgery More Lymph Nodes Removed, Better Survival — But at What Cost?
This systematic review analyzed 993 randomized participants undergoing radical cystectomy for muscle-invasive or treatment-refractory non-mu…
This surgery could help some live longer, but it’s not risk-free.
Cochrane Apr 23, 2026
Meta-analysis finds 3.2% prevalence of germline MMR mutations in patients with upper tract urothelial carcinoma
Gastroenterology Meta-analysis
Meta-analysis finds 3.2% prevalence of germline MMR mutations in patients with upper tract urothelial carcinoma Study finds 3.2% of upper tract urothelial cancer patients have inherited DNA repair mutations
A systematic review and meta-analysis of 14 studies including 2378 patients with upper tract urothelial carcinoma (UTUC) found a pooled prev…
About 3% of upper tract urothelial cancer patients carry inherited DNA repair mutations that link their cancer to Lynch syndrome and affect …
Apr 5, 2026
Renal pelvis tumors show survival advantage over other UTUC sites in NCDB analysis
Urology Cohort
Renal pelvis tumors show survival advantage over other UTUC sites in NCDB analysis Study finds kidney pelvis tumors linked to better survival in urinary tract cancer
A retrospective cohort study of 12,300 patients with upper urinary tract urothelial carcinoma from the National Cancer Database found renal …
Patients with kidney pelvis tumors had better survival than those with tumors in other upper urinary tract locations, based on analysis of o…
Frontiers Apr 3, 2026

Questions about urothelial carcinoma

How does disitamab vedotin-based therapy work for metastatic urothelial carcinoma patients?

Disitamab vedotin targets HER2 on cancer cells and delivers a toxin directly, often combined with a PD-1 inhibitor to boost the immune response, showing high response rates in metastatic urothelial carcinoma.

Full answer →
Is OPDIVO QVANTIG approved for treating urothelial carcinoma by the FDA?

No, OPDIVO QVANTIG is not FDA-approved for urothelial carcinoma; it is approved for renal cell carcinoma and melanoma only.

Full answer →
Can disitamab vedotin be used to treat HER2-negative urothelial carcinoma patients?

Yes, disitamab vedotin shows activity in HER2-negative urothelial carcinoma, but response rates are lower than in HER2-low or HER2-positive disease.

Full answer →
What are the response rates for disitamab vedotin plus PD-1 inhibitor in urothelial carcinoma?

Disitamab vedotin plus a PD-1 inhibitor shows high response rates in urothelial carcinoma, with objective response rates of 71% in first-line metastatic disease and 51% in HER2-low/negative populations.

Full answer →

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