Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06470282 · ClinicalTrials.gov registry record · Phase 1
Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer
A Phase 1 study of Bladder Cancer and Muscle-Invasive Bladder Carcinoma, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
- 1
- Study location
NCT06470282: Recruiting Phase 1 study of Bladder Cancer and Muscle-Invasive Bladder Carcinoma, sponsored by University of California, San Francisco.
NCT06470282 is a Phase 1 study of Bladder Cancer and Muscle-Invasive Bladder Carcinoma that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 47 participants, below the 12,753-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
NCT06470282, a Phase 1 study of Bladder Cancer and Muscle-Invasive Bladder Carcinoma, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib/II trial studies the side effects, best dose, and effectiveness of enfortumab vedotin (EV) in combination with pembrolizumab and radiation therapy for treating patients with muscle invasive bladder cancer. Standard of care treatment for muscle invasive bladder cancer is chemotherapy, to shrink the tumor before the main treatment is given (neoadjuvant), followed by surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). In cases where patients are not candidates for the standard of care approach or prefer a bladder sparing option, tri-modality therapy with transurethral resection of bladder tumor (TURBT) followed by combined chemotherapy and radiation therapy is used. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Intensity-modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Giving enfortumab vedotin with pembrolizumab and radiation therapy may work better in treating patients with muscle invasive bladder cancer.
Primary Outcome
The RP2D is the last dose cohort at which no more than one instance of a dose limiting toxicity (DLT) is observed among 6 participants treated. If the maximum tolerated dose (MTD) cannot be determined due to lack of DLT during the DLT window, the maximum dose level of enfortumab vedotin administered during the study will be declared the RP2D. For the purposes of this study, the RP2D is the MTD.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Enfortumab Vedotin
- RADIATION Intensity Modulated Radiation Therapy (IMRT)
- PROCEDURE Transurethral Resection of Bladder Tumor
- PROCEDURE Cystoscopy (CS)
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2025-03-31 |
| Est. Completion | 2028-01-31 |
| Phase | Phase 1 |
What NCT06470282 shows while recruiting
NCT06470282 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
The record links to 4 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT06470282 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06470282 about?
NCT06470282 is a clinical study titled "Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer". This phase Ib/II trial studies the side effects, best dose, and effectiveness of enfortumab vedotin (EV) in combination with pembrolizumab and radiation therapy for treating patients with muscle invasive bladder cancer. Standard of care treatment for muscle invasive bladder cancer is chemotherapy, t...
What is the current status of trial NCT06470282?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2025-03-31. Estimated completion is 2028-01-31.
What conditions does trial NCT06470282 study?
This clinical trial studies the following conditions: Bladder Cancer, Muscle-Invasive Bladder Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8.
What interventions are being tested in trial NCT06470282?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Enfortumab Vedotin (DRUG), Intensity Modulated Radiation Therapy (IMRT) (RADIATION), Transurethral Resection of Bladder Tumor (PROCEDURE), Cystoscopy (CS) (PROCEDURE).
Who is sponsoring clinical trial NCT06470282?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06470282 being conducted?
This trial has 1 study location across California. 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 NCT06470282's enrollment target sits among peer trials
47 120th of 175 higher than 56 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
- NCT03313011 · 47 participants
The Neurobiology of Two Distinct Types of Progressive Apraxia of Speech
- NCT03467516 · 47 participants · Phase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma
- NCT03886662 · 47 participants · Phase 1
A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
- NCT04013802 · 47 participants · Phase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
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