Trial · NCT06104618
Enfortumab Vedotin for the Treatment of Patients With Metastatic or Unresectable Squamous Cell Carcinoma of the Penis
NCT06104618, Phase 2, Recruiting, Mayo Clinic
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Enfortumab Vedotin for the Treatment of Patients With Metastatic or Unresectable Squamous Cell Carcinoma of the Penis. Trials, record NCT06104618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06104618
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Enfortumab Vedotin for the Treatment of Patients With Metastatic or Unresectable Squamous Cell Carcinoma of the Penis
- NCT number
- NCT06104618
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 28 participants, estimated
- Lead sponsor
- Mayo Clinic
- Conditions
- Metastatic Penile Squamous Cell Carcinoma, Stage III Penile Cancer AJCC v8, Stage IV Penile Cancer AJCC v8, Unresectable Penile Squamous Cell Carcinoma
- Interventions
- Enfortumab Vedotin, Computed Tomography, Magnetic Resonance Imaging
- First posted
- 2023-10-27
- Last updated
- 2026-06-08
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best response rate | Up to 5 years | 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. |
| Secondary | Objective response rate (ORR) | Up to 5 years | Defined as the proportion of patients who experience either a confirmed partial response or confirmed complete response as defined by RECIST v1.1. ORR will be reported descriptively and a 95% confidence interval will be reported. |
| Secondary | Progression free survival (PFS) | From study entry to the first of either disease progression or death from any cause, up to 5 years | Will be estimated using the Kaplan-Meier method. The median PFS and 95% confidence interval will be reported. |
| Secondary | Overall survival (OS) | From study entry to death from any cause, up to 5 years | Will be estimated using the Kaplan-Meier method. The median OS and 95% confidence interval will be reported. |
| Secondary | Incidence of adverse events | Up to 30 days after last dose of study medication | The maximum grade for each type of adverse event by patient will be summarized by frequencies and percentages using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Secondary | Duration of Response | Up to 5 years | Defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. |
| Secondary | Best response by human papillomavirus (HPV) status | Up to 5 years | The p16 biomarker will be used to assess HPV status. The p16 immunohistochemistry (IHC) outcome will be classified as positive, negative, or not available. Best response rates of either a CR or PR will be determined for each subgroup and 95% confidence intervals will be reported. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06104618
GET https://conductscience.org/api/trials/v1/NCT06104618/registered