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NCT06104618 · ClinicalTrials.gov registry record · Phase 2
Enfortumab Vedotin for the Treatment of Patients With Metastatic or Unresectable Squamous Cell Carcinoma of the Penis
A Phase 2 study of Metastatic Penile Squamous Cell Carcinoma and Stage III Penile Cancer AJCC v8, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 3
- Study locations
NCT06104618: Recruiting Phase 2 study of Metastatic Penile Squamous Cell Carcinoma and Stage III Penile Cancer AJCC v8, sponsored by Mayo Clinic.
NCT06104618 is a Phase 2 study of Metastatic Penile Squamous Cell Carcinoma and Stage III Penile Cancer AJCC v8 that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06104618, a Phase 2 study of Metastatic Penile Squamous Cell Carcinoma and Stage III Penile Cancer AJCC v8, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial tests how well enfortumab vedotin works for treating patients with squamous cell carcinoma of the penis that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). 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.
Primary Outcome
Defined as the proportion of patients who experience either a partial response (PR) or complete response (CR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The best response rate of CR/PR will be reported descriptively and a 95% confidence interval will be reported.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- DRUG Enfortumab Vedotin
- PROCEDURE Magnetic Resonance Imaging
Study Locations (3)
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
Florida
- Mayo Clinic in Florida - Jacksonville
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2023-12-21 |
| Est. Completion | 2026-11-01 |
| Phase | Phase 2 |
What NCT06104618 shows while recruiting
NCT06104618 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 4 conditions, with Metastatic Penile Squamous Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Computed Tomography is the first listed.
NCT06104618 reports a single indexed study location in Arizona, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT06104618 about?
NCT06104618 is a clinical study titled "Enfortumab Vedotin for the Treatment of Patients With Metastatic or Unresectable Squamous Cell Carcinoma of the Penis". This phase II trial tests how well enfortumab vedotin works for treating patients with squamous cell carcinoma of the penis that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an a...
What is the current status of trial NCT06104618?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2023-12-21. Estimated completion is 2026-11-01.
What conditions does trial NCT06104618 study?
This clinical trial studies the following conditions: Metastatic Penile Squamous Cell Carcinoma, Stage III Penile Cancer AJCC v8, Stage IV Penile Cancer AJCC v8, Unresectable Penile Squamous Cell Carcinoma.
What interventions are being tested in trial NCT06104618?
The interventions under investigation include: Computed Tomography (PROCEDURE), Enfortumab Vedotin (DRUG), Magnetic Resonance Imaging (PROCEDURE).
Who is sponsoring clinical trial NCT06104618?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06104618 being conducted?
This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06104618's enrollment target sits among peer trials
28 1677th of 2000 higher than 305 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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