Metastatic Urothelial Carcinoma

Oncology
2
Pipeline Programs
2
Companies
16
Clinical Trials
4 recruiting
0
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

ADC
1100%
+ 1 programs with unclassified modality

Competitive Landscape

2 companies ranked by most advanced pipeline stage

Pfizer
PfizerNEW YORK, NY
1 program
1
Enfortumab VedotinPhase 4ADC5 trials
Active Trials
NCT04136808Approved For Marketing
NCT06862219Recruiting100Est. Dec 2027
NCT06809140Recruiting47Est. Nov 2029
+2 more trials
ImmunityBio
ImmunityBioSAN DIEGO, CA
1 program
1
Nogapendekin Alfa InbakiceptPhase 11 trial
Active Trials
NCT07217496Not Yet RecruitingEst. May 2027

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
PfizerEnfortumab Vedotin
PfizerEnfortumab Vedotin
PfizerEnfortumab Vedotin
PfizerEnfortumab Vedotin
PfizerEnfortumab Vedotin
PfizerEnfortumab Vedotin
PfizerEnfortumab Vedotin
PfizerEnfortumab Vedotin
PfizerEnfortumab Vedotin
PfizerEnfortumab Vedotin
ImmunityBioNogapendekin Alfa Inbakicept
PfizerEnfortumab Vedotin
PfizerEnfortumab Vedotin
PfizerEnfortumab Vedotin
PfizerEnfortumab Vedotin

Clinical Trials (16)

Total enrollment: 3,866 patients across 16 trials

NCT06862219PfizerEnfortumab Vedotin

A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer

Start: Jun 2025Est. completion: Dec 2027100 patients
Phase 4Recruiting
NCT04700124PfizerEnfortumab Vedotin

Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)

Start: Apr 2021Est. completion: Oct 2025808 patients
Phase 3Completed
NCT04223856PfizerEnfortumab Vedotin

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

Start: Mar 2020Est. completion: Mar 2028886 patients
Phase 3Active Not Recruiting
NCT03924895PfizerEnfortumab Vedotin

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)

Start: Jul 2019Est. completion: Dec 2027595 patients
Phase 3Active Not Recruiting
NCT06809140PfizerEnfortumab Vedotin

Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer

Start: Apr 2025Est. completion: Nov 202947 patients
Phase 2Recruiting
NCT05239624PfizerEnfortumab Vedotin

Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer

Start: Jun 2022Est. completion: Jun 202723 patients
Phase 2Recruiting
NCT04995419PfizerEnfortumab Vedotin

A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 ( PD 1) / (Programmed Death Ligand-1 (PD-L1) Inhibitor Therapy

Start: Jul 2021Est. completion: Aug 202540 patients
Phase 2Completed
NCT04225117PfizerEnfortumab Vedotin

A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

Start: Mar 2020Est. completion: Sep 2026329 patients
Phase 2Active Not Recruiting
NCT03219333PfizerEnfortumab Vedotin

A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

Start: Oct 2017Est. completion: Jul 2023219 patients
Phase 2Completed
NCT03288545PfizerEnfortumab Vedotin

A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

Start: Oct 2017Est. completion: Sep 2026348 patients
Phase 1/2Active Not Recruiting
NCT07217496ImmunityBioNogapendekin Alfa Inbakicept

N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer

Start: Feb 2026Est. completion: May 2027
Phase 1Not Yet Recruiting
NCT05014139PfizerEnfortumab Vedotin

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Start: Dec 2021Est. completion: Sep 202537 patients
Phase 1Terminated
NCT03070990PfizerEnfortumab Vedotin

A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma

Start: Apr 2017Est. completion: Feb 201919 patients
Phase 1Completed
NCT02091999PfizerEnfortumab Vedotin

A Study of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other Malignant Solid Tumors That Express Nectin-4

Start: May 2014Est. completion: Dec 2022213 patients
Phase 1Completed
NCT04136808PfizerEnfortumab Vedotin

An Expanded Access Treatment Protocol of Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma

N/AApproved For Marketing
NCT06011954PfizerEnfortumab Vedotin

A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection

Start: Nov 2023Est. completion: Jul 2027202 patients
N/ARecruiting

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

4 actively recruiting trials targeting 3,866 patients
2 companies competing in this space

Related Indications

Breast Cancer(530)Non-small Cell Lung Cancer(373)Prostate Cancer(371)Multiple Myeloma(244)Advanced Solid Tumors(221)Acute Myeloid Leukemia(204)Cancer(187)Neoplasms(173)Colorectal Cancer(166)Advanced Solid Tumor(165)