Study on Enfortumab Vedotin for Treating Advanced Penile Cancer
Sponsor: Mayo Clinic
ClinicalTrials ID:NCT06104618
This clinical trial is testing how well the drug enfortumab vedotin works in treating penile cancer that has spread or cannot be removed by surgery. The drug targets a protein on cancer cells to help the immune system slow or stop tumor growth.
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Program Overview
This phase II study is exploring the effectiveness of enfortumab vedotin in patients with penile squamous cell carcinoma that has either spread to other parts of the body or cannot be surgically removed. Enfortumab vedotin is a type of treatment that combines an antibody with a cancer-fighting drug, targeting a specific protein on cancer cells to deliver the drug directly to them and kill them.
Description
The main goal of this study is to see how well enfortumab vedotin works in shrinking tumors in patients with advanced penile cancer. Researchers will also look at how safe the drug is, how long the response lasts, and how it affects overall survival and disease progression. The study will also examine how the drug works in patients with different HPV statuses.
Participants will receive enfortumab vedotin through an IV on specific days of each 28-day cycle. Treatment will continue as long as the cancer does not progress and side effects are manageable. After finishing the treatment, patients will have follow-up visits to monitor their health and the status of their cancer.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of squamous cell carcinoma of the penis.
- Have cancer that has spread or cannot be removed by surgery.
- Must have measurable disease according to specific criteria.
- Can have had previous cancer treatments or be new to treatment.
- Must be in good general health with a performance status of 0 or 1.
- Must have adequate blood counts and organ function based on recent tests.
- Must agree to return for follow-up visits during the study.
- Must provide written informed consent to participate.
Exclusion Criteria
- Have a different type of penile cancer or cancer in the urethra.
- Have significant nerve damage or active brain metastases, unless stable and treated.
- Have uncontrolled diabetes or have not recovered from recent major treatments.
- Have active infections or other serious health conditions.
- Be taking other investigational drugs or have active hepatitis B or C.
- Have known allergies to the study drug or its components.
- Have had another active cancer within the last two years, except for certain skin or bladder cancers.
- Be unwilling to use effective birth control if sexually active.
- Have other severe health issues that would interfere with the study.
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