Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06394570 · ClinicalTrials.gov registry record · Phase 1
Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer
A Phase 1 study of Bladder Cancer, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT06394570: Recruiting Phase 1 study of Bladder Cancer, sponsored by University of Texas Southwestern Medical Center.
NCT06394570 is a Phase 1 study of Bladder Cancer that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 19 participants, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06394570, a Phase 1 study of Bladder Cancer, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
STAR-EV will evaluate the combination of enfortumab vedotin plus radiotherapy (RT) as neoadjuvant treatment for muscle invasive bladder cancer prior to radical cystectomy surgery. The study will use "dose escalation" to evaluate the safety and efficacy of study treatment at three dose regimens: Level 0: EV treatment followed by RT to the bladder Level 1: EV treatment with RT starting on Cycle 2, Day 15 Level 2: EV treatment with RT starting on Cycle 1, Day 15 Following completion of EV+RT neoadjuvant therapy, all subjects will undergo surgery as part of routine care.
Primary Outcome
A standard 3 + 3 dose escalation schedule will be used for all escalations. Enfortumab Vedotin will be given for three 21 day cycles. Radiation therapy will be administered at dose level 0, level 1 or level 2.
Conditions Studied
Interventions
- DRUG Enfortumab vedotin
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2024-09-10 |
| Est. Completion | 2027-07-01 |
| Phase | Phase 1 |
What NCT06394570 shows while recruiting
NCT06394570 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 1 intervention - of which Enfortumab vedotin is the first listed.
NCT06394570 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06394570 about?
NCT06394570 is a clinical study titled "Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer". STAR-EV will evaluate the combination of enfortumab vedotin plus radiotherapy (RT) as neoadjuvant treatment for muscle invasive bladder cancer prior to radical cystectomy surgery. The study will use "dose escalation" to evaluate the safety and efficacy of study treatment at three dose regimens: Lev...
What is the current status of trial NCT06394570?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2024-09-10. Estimated completion is 2027-07-01.
What conditions does trial NCT06394570 study?
This clinical trial studies the following conditions: Bladder Cancer.
What interventions are being tested in trial NCT06394570?
The interventions under investigation include: Enfortumab vedotin (DRUG).
Who is sponsoring clinical trial NCT06394570?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06394570 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bladder Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06394570's enrollment target sits among peer trials
19 155th of 175 higher than 20 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.
RECRUITING · Phase 1
-
KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04)
RECRUITING · Phase 1
-
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas
RECRUITING · Phase 1
-
A Study of MGC026 in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
-
Sacituzumab Govitecan Plus EV in Metastatic UC
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03207464 · 19 participants · Phase 1
Molecular Imaging of NET Using [C-11]MRB-PET in MS
- NCT04318717 · 19 participants · Phase 2
Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma
- NCT05103904 · 19 participants · Phase 2
Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant
- NCT05607407 · 19 participants · Phase 2
Methimazole in Patients With Progressive Glioblastoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI