Urinary bladder neoplasm

Summary

Urinary bladder neoplasm (MONDO:0004987) is a cancer (an umbrella term covering 6 Mondo subtypes) and 191 clinical trials. Top therapeutic interventions include mitomycin, enfortumab vedotin, and gemcitabine. A subtype of urinary bladder disorder — broader associated-gene and molecular evidence is on the parent page (see Disease family below).

At a glance

• Classification: Cancer
• Umbrella term: 6 Mondo subtypes
• Clinical trials: 191

Clinical features

No curated clinical features (Orphanet) for this disease.

Identifiers

Disease identifiers

Field	Value
Canonical name	urinary bladder neoplasm
Mondo ID	MONDO:0004987
EFO	EFO:0000294
NCIT	C2901
SNOMED CT	126885006
UMLS	C0005695
MedGen	594
Anatomy (UBERON)	UBERON:0001255
Is cancer (heuristic)	yes

Also known as: bladder neoplasm · bladder tumor · bladder tumors · bladder tumour · bladder tumours · neoplasm of bladder · neoplasm of the bladder · neoplasm of the urinary bladder · neoplasm of urinary bladder · tumor of bladder · tumor of the bladder · tumor of the urinary bladder · tumor of urinary bladder · tumour of bladder · tumour of the bladder · tumour of the urinary bladder · tumour of urinary bladder · urinary bladder neoplasm · urinary bladder neoplasm (disease) · urinary bladder neoplasms (+4 more)

Disease family

This is a subtype of urinary bladder disorder. Genetic, therapeutic, and trial evidence is largely curated at the broader-term level — see the parent page for the associated-gene cohort and molecular evidence.

Classification path: disease › human disease › disease by body system or component › urinary system disorder › urinary bladder disorder › urinary bladder neoplasm

Related subtypes (16): low compliance bladder, detrusor sphincter dyssynergia, female stress incontinence, urinary bladder tuberculosis, urinary schistosomiasis, vesicoureteral reflux, cystitis, overactive bladder, bladder calculus, bladder neck obstruction, postcholecystectomy syndrome, ureterolithiasis, bladder diverticulum, ureterocele, Hinman syndrome, disorder of neck of urinary bladder

Subtypes (6): bladder benign neoplasm, urinary bladder cancer, urinary bladder villous adenoma, bladder papillary urothelial neoplasm, bladder flat intraepithelial lesion, bladder inflammatory myofibroblastic tumor

Genetics & variants

GWAS landscape

No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.

Variant details and genetic-evidence tiers

No tiered GWAS variants or ClinVar records for this disease.

Genes & proteins

No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).

Function

No pathway enrichment — requires an associated-gene cohort.

Therapeutics

Drugs indicated for this disease

1 approved, 14 in late-stage (phase 3) trials. Disease-direct ChEMBL indications, not inferred from the associated-gene cohort below.

Drug	Development status
Erdafitinib	Approved (phase 4)
Apaziquone	Phase 3 (in late-stage trials)
Cetrelimab	Phase 3 (in late-stage trials)
Cisplatin	Phase 3 (in late-stage trials)
Durvalumab	Phase 3 (in late-stage trials)
Fluorouracil	Phase 3 (in late-stage trials)
Gemcitabine	Phase 3 (in late-stage trials)
Larotaxel	Phase 3 (in late-stage trials)
Mitomycin	Phase 3 (in late-stage trials)
Nivolumab	Phase 3 (in late-stage trials)
Oportuzumab Monatox	Phase 3 (in late-stage trials)
Paclitaxel	Phase 3 (in late-stage trials)
Pembrolizumab	Phase 3 (in late-stage trials)
Tislelizumab	Phase 3 (in late-stage trials)
Vinflunine	Phase 3 (in late-stage trials)

Earlier-phase candidates (phase 2, investigational — efficacy not yet established): Balstilimab, Camrelizumab, Lenalidomide, Linrodostat, Olaparib, Sulforaphane, Sunitinib, Tamoxifen.

Clinical trials & evidence

Clinical trials

Clinical trials: 191.

Phase distribution (across all retrieved trials)

Phase	Trials
Not specified	86
PHASE2	36
PHASE1	21
PHASE3	19
PHASE1/PHASE2	16
PHASE4	5
EARLY_PHASE1	5
PHASE2/PHASE3	3

Top trials by phase / activity

NCT	Phase	Status	Title
NCT01876836	PHASE4	UNKNOWN	Clasic Laryngeal Mask Airway(C-LMA) and I-gel Releated Regurgitation and Complications
NCT02350543	PHASE4	TERMINATED	Peri-operative Aspirin Continuation Versus Discontinuation
NCT02696733	PHASE4	UNKNOWN	Ultrasound-Guided ONB for Transurethral Procedures - Interadductor Approach
NCT03029676	PHASE4	UNKNOWN	The Assessment of POCD After TURBT Under Spinal Anesthesia
NCT05068180	PHASE4	UNKNOWN	Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients
NCT03661320	PHASE3	ACTIVE_NOT_RECRUITING	A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
NCT04241185	PHASE3	ACTIVE_NOT_RECRUITING	Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)
NCT04658862	PHASE3	ACTIVE_NOT_RECRUITING	A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
NCT05786716	PHASE2/PHASE3	RECRUITING	DETERMINE Trial Treatment Arm 04: Trastuzumab in Combination With Pertuzumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With HER2 Amplification or Activating Mutations
NCT06441110	PHASE3	RECRUITING	Multicenter Clinical Trial on the Effectiveness and Safety of Instillation of BCG and Alternative BCG Protocols for Intermediate and High-risk Non-muscle Invasive Bladder Cancer
NCT06960577	PHASE3	RECRUITING	Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
NCT07067749	PHASE3	RECRUITING	Treatment Expedition With MRI Processing and Optimization for Muscle Invasive Bladder Cancer
NCT07218380	PHASE3	RECRUITING	A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract
NCT07566156	PHASE3	RECRUITING	Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer ( EV-309 )
NCT07608224	PHASE2/PHASE3	NOT_YET_RECRUITING	HOPE-07-MIBC: Disitamab Vedotin Plus Immunotherapy vs Chemoimmunotherapy in Resectable HER2-Expressing MIBC
NCT00191477	PHASE3	TERMINATED	Instillation of Gemcitabine in Patients With Superficial Bladder Cancer
NCT00315237	PHASE3	COMPLETED	Phase III Trial of Vinflunine Plus Best Supportive Care vs. Best Supportive Care in Patients With Transitional Cell Carcinoma (TCC) of the Urothelial Tract
NCT00384891	PHASE3	TERMINATED	Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy (BCG) for Superficial Bladder Cancer
NCT00406068	PHASE2/PHASE3	COMPLETED	Mycobacterial Cell Wall-DNA Complex in Treatment of BCG-refractory Patients With Non-muscle Invasive Bladder Cancer
NCT00625664	PHASE3	COMPLETED	Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
NCT01200992	PHASE3	TERMINATED	Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer
NCT01581723	PHASE3	UNKNOWN	Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor
NCT02254915	PHASE3	WITHDRAWN	SHTC - EUROPE-1 Synergo Hyperthermia-Chemotherapy by European Urologists’ Research Operation Preserving Evolution Study I
NCT02695771	PHASE3	COMPLETED	The Bladder Instillation Comparison Study
NCT03335059	PHASE3	TERMINATED	Mitomycin C Intravesical Chemotherapy in Conjunction With Synergo® Radiofrequency-Induced Hyperthermia for Treatment of Carcinoma in Situ Non-Muscle Invasive Bladder Cancer Patients Unresponsive to Bacillus Calmette-Guérin, With or Without Papillary Tumors.
NCT04149574	PHASE3	TERMINATED	A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)
NCT04209114	PHASE3	COMPLETED	A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer
NCT02489890	PHASE2	ACTIVE_NOT_RECRUITING	CIK in Treating Patients With Bladder Cancer
NCT03459846	PHASE2	ACTIVE_NOT_RECRUITING	A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)
NCT04561362	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies
NCT04640623	PHASE2	ACTIVE_NOT_RECRUITING	A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
NCT04706598	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	Safety and Efficacy of Camrelizumab for High-risk NMIBC Failing BCG Treatment
NCT04919512	PHASE2	ACTIVE_NOT_RECRUITING	A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder
NCT05072600	PHASE2	RECRUITING	Pembrolizumab Monotherapy Following Tri-modality Treatment for Selected Patients With Muscle-invasive Bladder Cancer
NCT05944237	PHASE1/PHASE2	RECRUITING	HTL0039732 in Participants With Advanced Solid Tumours
NCT06237920	PHASE2	RECRUITING	Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab
NCT06528483	PHASE2	NOT_YET_RECRUITING	Bladder Preservation With Sacituzumab Govitecan + Zimberelimab for Muscle-Invasive Bladder Cancer
NCT06833073	PHASE2	RECRUITING	A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
NCT06892860	PHASE2	RECRUITING	Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer
NCT07189793	PHASE2	NOT_YET_RECRUITING	Toripalimab ± Sequential Intravesical Gemcitabine-Mitomycin C for BCG-Unresponsive/-Intolerant High-Risk NMIBC: Open-Label Randomized Phase 2 Study

Drugs tested across these trials (top 30)

Molecule	Max phase	Trials referencing
MITOMYCIN	4	7
ENFORTUMAB VEDOTIN	4	4
GEMCITABINE	4	2
VINFLUNINE	4	2
ASPIRIN	4	1
BUPIVACAINE	4	1
CABOZANTINIB	4	1
CATUMAXOMAB	4	1
CRIZOTINIB	4	1
CYANOCOBALAMIN	4	1
DESFLURANE	4	1
DURVALUMAB	4	1
ERDAFITINIB	4	1
NIVOLUMAB	4	1
OLIVE OIL	4	1
PERTUZUMAB	4	1
PRALATREXATE	4	1
RELATLIMAB	4	1
ROCURONIUM BROMIDE	4	1
SACITUZUMAB GOVITECAN	4	1
TERFENADINE	4	1
TORIPALIMAB	4	1
VINBLASTINE	4	1
CETRELIMAB	3	3
BEMPEGALDESLEUKIN	3	2
OPORTUZUMAB MONATOX	3	2
SURAMIN	3	2
APAZIQUONE	3	1
BALSTILIMAB	3	1
DISITAMAB VEDOTIN	3	1