Urothelial Carcinoma

Oncology
23
Pipeline Programs
16
Companies
50
Clinical Trials
5 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
7
8
0
4
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
1376%
ADC
424%
+ 10 programs with unclassified modality

On Market (1)

Approved therapies currently available

M&
KEYTRUDAApproved
pembrolizumab
Merck & Co.
Programmed Death Receptor-1 Blocking Antibody [EPC]intravenous2014

Competitive Landscape

16 companies ranked by most advanced pipeline stage

M&
Merck & Co.RAHWAY, NJ
4 programs
1
2
1
PembrolizumabPhase 3Monoclonal Antibody
disitamab vedotinPhase 3ADC
Enfortumab vedotinPhase 2ADC
AvelumabN/AMonoclonal Antibody
BeOne Medicines
BeOne MedicinesCA - San Carlos
2 programs
1
1
TislelizumabPhase 3Monoclonal Antibody1 trial
BGB-A445Phase 1/21 trial
Active Trials
NCT05661955Active Not RecruitingEst. Oct 2026
NCT03967977RecruitingEst. Oct 2027
E
EisaiChina - Liaoning
1 program
1
PembrolizumabPhase 3Monoclonal Antibody1 trial
Active Trials
NCT03898180Completed505Est. May 2024
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
5 programs
1
2
Abiraterone acetatePhase 23 trials
TremelimumabPhase 2Monoclonal Antibody1 trial
DurvalumabPhase 1/2Monoclonal Antibody1 trial
Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDERN/A1 trial
Prevalence of PD-L1 Expression in Patients With Advanced Urothelial CarcinomaN/A1 trial
Active Trials
NCT05945108Completed400Est. Apr 2024
NCT03788746Completed181Est. May 2023
NCT03317158Recruiting55Est. Dec 2026
+4 more trials
Genentech
GenentechCA - Oceanside
2 programs
1
AtezolizumabPhase 2Monoclonal Antibody1 trial
Atezolizumab [TECENTRIQ]N/A1 trial
Active Trials
NCT02589717Approved For MarketingEst. Aug 2016
NCT03272217Terminated16Est. Mar 2022
Astellas
AstellasChina - Shenyang
2 programs
1
1
Enfortumab VedotinPhase 2ADC1 trial
AtezolizumabPhase 1/2Monoclonal Antibody
Active Trials
NCT05868265Recruiting24Est. Jun 2027
GS
Gilead SciencesFOSTER CITY, CA
2 programs
1
1
Sacituzumab GovitecanPhase 2ADC1 trial
AtezolizumabPhase 1/2Monoclonal Antibody1 trial
Active Trials
NCT03869190Completed272Est. Dec 2025
NCT06682728Recruiting23Est. Dec 2026
AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
LivmoniplimabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT06632951Active Not Recruiting150Est. Aug 2028
Bristol Myers Squibb
1 program
1
Nivolumab in combination with UrelumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT02845323Active Not Recruiting15Est. Dec 2026
BP
Basilea PharmaceuticaSwitzerland - Allschwil
1 program
1
Derazantinib 300 mg once daily monotherapyPhase 1/21 trial
Active Trials
NCT04045613CompletedEst. Oct 2022
LP
Lee's PharmaceuticalChina - Guangzhou
1 program
1
ZKAB001 5mg/kgPhase 1/21 trial
Active Trials
NCT03676946Unknown15Est. Jun 2023
ImmunityBio
ImmunityBioSAN DIEGO, CA
1 program
1
avelumabPhase 1/2Monoclonal Antibody1 trial
Active Trials
NCT03197571Withdrawn0Est. Dec 2021
Kyowa Hakko Kirin
Kyowa Hakko KirinCA - La Jolla
1 program
1
KHK2455Phase 11 trial
Active Trials
NCT03915405Terminated16Est. Nov 2022
Vyriad
VyriadMN - Rochester
1 program
1
MV-NISPhase 11 trial
Active Trials
NCT03171493CompletedEst. May 2023
Pierre Fabre
Pierre FabreFrance - Aignan
1 program
1
VinfluninePhase 1
Pfizer
PfizerNEW YORK, NY
1 program
AvelumabN/AMonoclonal Antibody5 trials
Active Trials
NCT03089658Approved For Marketing
NCT05699135Terminated150Est. Jun 2023
NCT05059522Active Not Recruiting68Est. Sep 2026
+2 more trials

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
PfizerAvelumab
AstraZenecaAbiraterone acetate
BeOne MedicinesTislelizumab
EisaiPembrolizumab
PfizerAvelumab
PfizerAvelumab
PfizerAvelumab
PfizerAvelumab
PfizerAvelumab
AbbVieLivmoniplimab
Gilead SciencesSacituzumab Govitecan
AstellasEnfortumab Vedotin
AstraZenecaAbiraterone acetate
PfizerAvelumab
PfizerAvelumab

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 6,463 patients across 50 trials

Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing

Start: Sep 2021Est. completion: Sep 202668 patients
Phase 3Active Not Recruiting
NCT04493853AstraZenecaAbiraterone acetate

Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency

Start: Jul 2020Est. completion: Mar 20271,012 patients
Phase 3Active Not Recruiting

Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma

Start: May 2019Est. completion: Oct 2027
Phase 3Recruiting
NCT03898180EisaiPembrolizumab

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)

Start: May 2019Est. completion: May 2024505 patients
Phase 3Completed

Avelumab and Talazoparib in Untreated Advanced Ovarian Cancer (JAVELIN OVARIAN PARP 100)

Start: Jul 2018Est. completion: Dec 202179 patients
Phase 3Terminated

Avelumab In Combination Regimens That Include An Immune Agonist, Epigenetic Modulator, CD20 Antagonist and/or Conventional Chemotherapy in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

Start: Dec 2016Est. completion: Dec 201929 patients
Phase 3Terminated

Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100)

Start: Nov 2016Est. completion: Aug 2020697 patients
Phase 3Terminated

Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)

Start: May 2016Est. completion: May 2019998 patients
Phase 3Terminated

A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)

Start: Apr 2016Est. completion: Mar 2023700 patients
Phase 3Completed
NCT06632951AbbVieLivmoniplimab

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)

Start: Jan 2025Est. completion: Aug 2028150 patients
Phase 2Active Not Recruiting
NCT06682728Gilead SciencesSacituzumab Govitecan

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

Start: Nov 2024Est. completion: Dec 202623 patients
Phase 2Recruiting
NCT05868265AstellasEnfortumab Vedotin

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

Start: Jun 2023Est. completion: Jun 202724 patients
Phase 2Recruiting
NCT05137262AstraZenecaAbiraterone acetate

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

Start: Oct 2021Est. completion: Aug 202612 patients
Phase 2Active Not Recruiting

TALazoparib and Avelumab as Maintenance Therapy in Platinum-Sensitive Metastatic or Locally Advanced URothelial Carcinoma

Start: Jun 2021Est. completion: Dec 202550 patients
Phase 2Recruiting

Avelumab in the Frontline Treatment of Advanced Classical Hodgkin Lymphoma - a Window Study

Start: Sep 2019Est. completion: May 202549 patients
Phase 2Unknown

Trial of Tremelimumab in Patients With Previously Treated Metastatic Urothelial Cancer

Start: Nov 2018Est. completion: Jun 202326 patients
Phase 2Completed

The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer

Start: Jun 2018Est. completion: May 2026100 patients
Phase 2Active Not Recruiting

Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors

Start: Jun 2018Est. completion: Feb 2023202 patients
Phase 2Terminated

Neoadjuvant AXITINIB and AVELUMAB for Patients With Localized Clear-cell RCC

Start: Mar 2018Est. completion: Jan 202540 patients
Phase 2Unknown

Pre-Operative Trial (PGHA vs. PGH) for Resectable Pancreatic Cancer

Start: Dec 2017Est. completion: Apr 201932 patients
Phase 2Terminated

Avelumab in Relapsed and Refractory Peripheral T-cell Lymphoma

Start: Dec 2017Est. completion: Jul 202135 patients
Phase 2Completed

A Study to Evaluate eFT508 Alone and in Combination With Avelumab in Subjects With MSS Colorectal Cancer

Start: Sep 2017Est. completion: May 201956 patients
Phase 2Completed

Atezolizumab With Bevacizumab in Previously Untreated Metastatic/Unresectable Urothelial Cancer

Start: Sep 2017Est. completion: Mar 202216 patients
Phase 2Terminated
NCT02845323Bristol Myers SquibbNivolumab in combination with Urelumab

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

Start: May 2017Est. completion: Dec 202615 patients
Phase 2Active Not Recruiting

A Phase II Trial of Avelumab in Patients With Recurrent or Progressive Osteosarcoma

Start: Feb 2017Est. completion: Mar 202019 patients
Phase 2Completed

Avelumab for Recurrent/Metastatic Nasopharyngeal Cancer

Start: Jan 2017Est. completion: Apr 20196 patients
Phase 2Terminated

Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer and of Avelumab/Talazoparib and Avelumab/Axitinib in Patients With MSS Recurrent or Persistent Endometrial Cancer

Start: Nov 2016Est. completion: Nov 2026106 patients
Phase 2Active Not Recruiting

A Study to Investigate the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of BGB-A445 in Combination With Tislelizumab in Participants With Select Advanced Solid Tumors.

Start: Jan 2023Est. completion: Oct 2026
Phase 1/2Active Not Recruiting

Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors

Start: Dec 2019Est. completion: Sep 20203 patients
Phase 1/2Terminated
NCT04045613Basilea PharmaceuticaDerazantinib 300 mg once daily monotherapy

Derazantinib and Atezolizumab in Patients With Urothelial Cancer

Start: Aug 2019Est. completion: Oct 2022
Phase 1/2Completed

Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

Start: Jun 2019Est. completion: Dec 2025272 patients
Phase 1/2Completed

TALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer

Start: Apr 2019Est. completion: Mar 202624 patients
Phase 1/2Active Not Recruiting

VXM01 Plus Avelumab Combination Study in Progressive Glioblastoma

Start: Nov 2018Est. completion: Dec 202230 patients
Phase 1/2Unknown

A Clinical Study of PD-L1 Antibody ZKAB001(Drug Code) in Locally Advanced and Metastatic Urothelial Carcinoma

Start: Oct 2018Est. completion: Jun 202315 patients
Phase 1/2Unknown

Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD)

Start: Oct 2018Est. completion: Feb 20190
Phase 1/2Withdrawn

A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab

Start: Apr 2018Est. completion: Aug 202268 patients
Phase 1/2Completed

Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies

Start: Dec 2017Est. completion: Dec 202267 patients
Phase 1/2Terminated

Stereotactic Body Radiation Therapy and Avelumab Immunotherapy for Treatment of Malignant Mesothelioma

Start: Dec 2017Est. completion: Jan 202315 patients
Phase 1/2Completed

QUILT-3.048: NANT Urothelial Cancer Vaccine: Combination Immunotherapy in Subjects With Urothelial Cancer Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 Therapy

Start: Dec 2017Est. completion: Dec 20210
Phase 1/2Withdrawn

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

Start: Nov 2017Est. completion: Dec 202655 patients
Phase 1/2Recruiting

SBRT Combined With Avelumab (Anti-PD-L1) for Management of Early Stage Non-Small Cell Lung Cancer (NSCLC)

Start: Oct 2017Est. completion: Oct 20192 patients
Phase 1/2Terminated

Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors

Start: Oct 2017Est. completion: Jan 2023223 patients
Phase 1/2Terminated

Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers

Start: Sep 2017Est. completion: Dec 2026143 patients
Phase 1/2Active Not Recruiting

A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley)

Start: Nov 2015Est. completion: Mar 2023409 patients
Phase 1/2Terminated

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

Start: Oct 2020Est. completion: Jan 202311 patients
Phase 1Completed

KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer

Start: Sep 2019Est. completion: Nov 202216 patients
Phase 1Terminated

Avelumab With Radiotherapy in Patients With Leptomeningeal Disease

Start: Jun 2019Est. completion: Aug 202416 patients
Phase 1Completed

Rituximab + Immunotherapy in Follicular Lymphoma

Start: Oct 2018Est. completion: Jul 202324 patients
Phase 1Terminated

A Combination of Avelumab and Taxane (AVETAX) for Urothelial Cancer

Start: Oct 2018Est. completion: Feb 202421 patients
Phase 1Completed

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

Start: Jul 2018Est. completion: May 2023
Phase 1Completed

Related Jobs in Oncology

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

4 late-stage (Phase 3) programs — potential near-term approvals
5 actively recruiting trials targeting 6,463 patients
Monoclonal Antibody is the dominant modality (76% of programs)
16 companies competing in this space