Medical Information Only. Consult your healthcare provider before considering clinical trial enrollment.

2026 data Public-data reference. official source

Urothelial Carcinoma

Open-data reference.

86 US clinical trials · 37 currently recruiting

Active & Recent Trials

RECRUITING 3,000 participants

Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer

Tampere University Hospital

NCT06310759

RECRUITING 1,650 participants

A Multicenter Cancer Biospecimen Collection Study

Cofactor Genomics

NCT04510129

RECRUITING 1,000 participants

Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria

Pacific Edge Limited

NCT05889195

RECRUITING NA 1,000 participants

Bladder Cancer Screening Trial

University of Texas Southwestern Medical Center

NCT05646485

RECRUITING Phase 1 949 participants

A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

Bristol-Myers Squibb

NCT04895709

RECRUITING NA 600 participants

An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy

University of Texas Southwestern Medical Center

NCT04623502

RECRUITING Phase 1 450 participants

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

Genentech

NCT05581004

RECRUITING 400 participants

uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto

UroGen Pharma

NCT05874921

RECRUITING Phase 2 372 participants

A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

Seagen, a wholly owned subsidiary of Pfizer

NCT04879329

RECRUITING Phase 1 317 participants

GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors

GI Innovation

NCT04977453

RECRUITING Phase 1 310 participants

A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors

Pfizer

NCT07090499

RECRUITING Phase 1 280 participants

Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors

SystImmune

NCT06293898

RECRUITING Phase 2 200 participants

A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors

Jazz Pharmaceuticals

NCT06695845

RECRUITING Phase 1 180 participants

A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors

Alentis Therapeutics

NCT07169734

RECRUITING 180 participants

Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments

Dana-Farber Cancer Institute

NCT06138561

RECRUITING Phase 1 158 participants

A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours

Avacta Life Sciences

NCT04969835

RECRUITING NA 150 participants

Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER)

University of California, Davis

NCT06101290

RECRUITING NA 128 participants

A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients With Bladder Cancer and Upper Tract Urothelial Cancer, Get Moving Trial

University of Washington

NCT06040762

RECRUITING Phase 1 103 participants

A Study of GEN1106 in Participants With Solid Tumors

Genmab

NCT07416123

RECRUITING Phase 1 100 participants

Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma

Nammi Therapeutics

NCT06582017

RECRUITING NA 94 participants

Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma

Case Comprehensive Cancer Center

NCT06262516

RECRUITING 92 participants

Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)

Fox Chase Cancer Center

NCT06396533

RECRUITING Phase 1 76 participants

Study to Evaluate LB-LR1109, Administered Alone for the Treatment of Solid Tumor and in Combination With Atezolizumab for the Treatment of NSCLC

LG Chem

NCT06332755

RECRUITING Phase 3 70 participants

A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer

UroGen Pharma

NCT06774131

RECRUITING NA 70 participants

Clinical Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy

Thomas Jefferson University

NCT07234968

RECRUITING Phase 1 60 participants

Study of DCC-2812 in Participants With Advanced Genitourinary Cancers

Deciphera Pharmaceuticals

NCT06966024

RECRUITING Phase 1 55 participants

Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder

Noah Hahn, M.D.

NCT03317158

RECRUITING Phase 2 55 participants

Gemcitabine and Carboplatin After Progression on Enfortumab Vedotin and Pembrolizumab in Advanced/Metastatic Urothelial Carcinoma

Fox Chase Cancer Center

NCT07043972

RECRUITING 50 participants

A Study of Neuropathy Caused by Enfortumab Vedotin in People With Urothelial Carcinoma

Memorial Sloan Kettering Cancer Center

NCT07390617

RECRUITING Phase 1 33 participants

Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

Zumutor Biologics

NCT06451497

RECRUITING Phase 2 32 participants

Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer

University of Michigan Rogel Cancer Center

NCT06356155

RECRUITING Phase 2 30 participants

Circulating Tumor DNA Response In Urothelial Cancer

University of Oklahoma

NCT07183319

RECRUITING Phase 2 24 participants

A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract

Memorial Sloan Kettering Cancer Center

NCT05868265

RECRUITING Phase 2 23 participants

Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer

Memorial Sloan Kettering Cancer Center

NCT05239624

RECRUITING Phase 2 23 participants

Adjuvant Sacituzumab Govitecan and Nivolumab in Muscle-Invasive Urothelial Carcinoma At High-Risk Recurrence

University of California, Irvine

NCT06682728

RECRUITING 16 participants

Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma

Fox Chase Cancer Center

NCT03291028

RECRUITING Early Phase 1 10 participants

Memory-like Natural Killer (NK) Cell Therapy in Patients With Renal Cell Carcinoma or Urothelial Carcinoma

Dana-Farber Cancer Institute

NCT06318871

ACTIVE NOT RECRUITING Phase 1 1,410 participants

Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01)

Klus Pharma

NCT04152499

ACTIVE NOT RECRUITING Phase 1 914 participants

Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

Exelixis

NCT03170960

ACTIVE NOT RECRUITING 589 participants

Identification of Novel High Quality Methylated DNA Markers in Renal Tumors: Whole Methylome Discovery, Tissue Validation, and Feasibility Testing In Blood and Urine, The INQUIRE Study

Mayo Clinic

NCT06339138

ACTIVE NOT RECRUITING Phase 3 412 participants

Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2

Seagen, a wholly owned subsidiary of Pfizer

NCT05911295

ACTIVE NOT RECRUITING Phase 3 367 participants

A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

CG Oncology

NCT06111235

ACTIVE NOT RECRUITING Phase 1 310 participants

Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations

Tyra Biosciences

NCT05544552

ACTIVE NOT RECRUITING Phase 1 296 participants

Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)

Inhibrx Biosciences

NCT04198766

ACTIVE NOT RECRUITING Phase 3 240 participants

A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

UroGen Pharma

NCT05243550

ACTIVE NOT RECRUITING Phase 2 150 participants

Study to Evaluate Adverse Events and Change in Disease Activity When Intravenously (IV) Infused Livmoniplimab is Used in Combination With IV Infused Budigalimab in Adult Participants With Urothelial Carcinoma (UC)

AbbVie

NCT06632951

ACTIVE NOT RECRUITING Phase 1 125 participants

A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer

Janssen Research & Development

NCT03473743

ACTIVE NOT RECRUITING Phase 2 103 participants

Multicohort Phase II Trial of sEphB4-HSA+Pembrolizumab in Solid Tumors

University of Southern California

NCT02717156

ACTIVE NOT RECRUITING Phase 3 99 participants

A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer

UroGen Pharma

NCT06331299

ACTIVE NOT RECRUITING NA 65 participants

Cystoscopic Evaluation Predicting pT0 Urothelial Carcinoma of the Bladder

Fox Chase Cancer Center

NCT02968732

ACTIVE NOT RECRUITING Phase 2 60 participants

Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma

Fox Chase Cancer Center

NCT05923190

ACTIVE NOT RECRUITING Phase 1 54 participants

A Phase II Study of Atezolizumab in Combination With Cisplatin + Gemcitabine Before Surgery to Remove the Bladder Cancer

Memorial Sloan Kettering Cancer Center

NCT02989584

ACTIVE NOT RECRUITING Phase 1 48 participants

A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)

Merck Sharp & Dohme

NCT05562830

ACTIVE NOT RECRUITING Phase 2 46 participants

Pembrolizumab in Muscle-invasive Bladder Cancer

Matthew Galsky

NCT05406713

ACTIVE NOT RECRUITING Phase 2 40 participants

QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors

ImmunityBio

NCT03228667

ACTIVE NOT RECRUITING Phase 2 32 participants

A Study of Two Dosing Schedules of Atezolizumab in Combination With Gemcitabine and Cisplatin as First-Line Treatment for Metastatic Bladder Cancer

Memorial Sloan Kettering Cancer Center

NCT03093922

ACTIVE NOT RECRUITING Phase 2 21 participants

Atezolizumab + Guadecitabine in Patients With Checkpoint Inhibitor Refractory or Resistant Urothelial Carcinoma

Fox Chase Cancer Center

NCT03179943

ACTIVE NOT RECRUITING Phase 1 19 participants

Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma

University of Oklahoma

NCT04004442

ACTIVE NOT RECRUITING Early Phase 1 16 participants

18Fluorine-Fluciclovine PET/CT for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy

Brigham and Women's Hospital

NCT04018053

ACTIVE NOT RECRUITING Phase 2 15 participants

Neoadjuvant Nivolumab With and Without Urelumab in Cisplatin-Ineligible or Chemotherapy-refusing Patients With Muscle-Invasive Urothelial Carcinoma of the Bladder

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

NCT02845323

ACTIVE NOT RECRUITING Phase 2 12 participants

A Phase II Multicenter Study of Chemotherapy Versus Chemotherapy Plus Durvalumab (MEDI 4736) in Patients With Lymph Node Positive Urothelial Carcinoma of the Bladder

M.D. Anderson Cancer Center

NCT05137262

ACTIVE NOT RECRUITING Phase 2 10 participants

A Phase 2 Study to Evaluate the Triplet Combination of Pemetrexed Plus AB928 (Etrumadenant) + AB122 (Zimberelimab) in Patients With Previously Treated Advanced or Metastatic MTAP Deficient Urothelial Carcinoma

M.D. Anderson Cancer Center

NCT05335941

ACTIVE NOT RECRUITING Phase 1 9 participants

Intravesical Adoptive Cell Therapy w/ TIL for BCG Exposed High Grade NMIBC

H. Lee Moffitt Cancer Center and Research Institute

NCT05768347

COMPLETED 803 participants

The Cxbladder Monitoring Study

Pacific Edge Limited

NCT02700659

COMPLETED NA 554 participants

STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA

Pacific Edge Limited

NCT03988309

COMPLETED NA 219 participants

UC-GENOME: Urothelial Cancer-GENOmic Analysis to iMprove Patient Outcomes and rEsearch

Matthew Milowsky, MD

NCT02643043

COMPLETED 181 participants

Prevalence of PD-L1 Expression in Patients With Advanced Urothelial Carcinoma

AstraZeneca

NCT03788746

COMPLETED Phase 1 150 participants

A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors

Xencor

NCT03517488

COMPLETED Phase 1 95 participants

Derazantinib and Atezolizumab in Patients With Urothelial Cancer

Basilea Pharmaceutica

NCT04045613

COMPLETED Phase 1 78 participants

A Phase 1a/b Study of IK-175 as a Single Agent and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors and Urothelial Carcinoma

Ikena Oncology

NCT04200963

COMPLETED Phase 2 69 participants

Cabozantinib for Advanced Urothelial Cancer

National Cancer Institute (NCI)

NCT01688999

COMPLETED Phase 1 44 participants

LYT-200 Alone and in Combination With Chemotherapy or Tislelizumab in Patients With Locally Advanced or Metastatic Solid Tumors

PureTech

NCT04666688

COMPLETED Phase 1 43 participants

Study of the CD40 Agonistic Monoclonal Antibody APX005M

Apexigen America

NCT02482168

COMPLETED Phase 1 38 participants

TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers

Tempest Therapeutics

NCT03829436

COMPLETED Phase 1 37 participants

Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma

Bayer

NCT03473756

COMPLETED Phase 2 36 participants

First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma

Hoosier Cancer Research Network

NCT01524991

COMPLETED Phase 2 30 participants

A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer

OncoNano Medicine

NCT03735680

COMPLETED Phase 1 29 participants

A Study of a Personalized Neoantigen Cancer Vaccine

Gritstone bio

NCT03639714

COMPLETED NA 27 participants

SAbR Induced Innate Immunity in Urothelial Carcinoma, Melanoma, and Cervical Carcinoma

University of Texas Southwestern Medical Center

NCT02986867

COMPLETED Early Phase 1 20 participants

Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

NCT03039413

COMPLETED Phase 1 19 participants

A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors

Cantargia AB

NCT04452214

COMPLETED Phase 1 12 participants

IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors

H. Lee Moffitt Cancer Center and Research Institute

NCT03758781

COMPLETED Phase 1 11 participants

GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy

Genome & Company

NCT04601402

COMPLETED Phase 2 8 participants

Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma

National Cancer Institute (NCI)

NCT02788201

COMPLETED Phase 1 8 participants

Trial of Intravesical Measles Virotherapy in Patients With Bladder Cancer Who Are Undergoing Radical Cystectomy

Vyriad

NCT03171493

COMPLETED Phase 3 8 participants

Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC)

UroGen Pharma

NCT05136898

Phase Distribution

PhaseTrial count
Early Phase 1 37
Phase 2 22
Phase 3 6

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Urothelial Carcinoma Trial Landscape

ClinicalTrials.gov lists 86 US studies indexed under Urothelial Carcinoma, and 37 of those are currently open to recruitment — roughly 43% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

The phase distribution for Urothelial Carcinoma shows 6 late-stage studies (Phase 3 and Phase 4 combined) alongside 59 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

Top sponsor activity for Urothelial Carcinoma is led by Fox Chase Cancer Center with 6 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 86 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Urothelial Carcinoma?

PlainTrial tracks 86 US clinical trials for Urothelial Carcinoma, of which 37 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Urothelial Carcinoma?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2024 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

Verify with NIH →