Study of enfortumab vedotin and avelumab for patients with advanced or metastatic penile cancer that has spread or cannot be removed by surgery

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What is this study about?

This study is looking at a treatment for penile squamous cell carcinoma that has spread to other parts of the body or has grown locally in an advanced way. Penile squamous cell carcinoma is a type of cancer that starts in the skin cells of the penis. The study will use two medications given together: enfortumab vedotin and avelumab. Both medications are given through a vein, which means they are delivered directly into the bloodstream through an infusion. The purpose of this study is to see how well this combination of medications works in treating patients with this type of cancer who have not received previous treatment for their advanced or spread disease.

Patients in this study will receive both medications over a period of up to 24 months. The study will measure how many patients have their tumors shrink or disappear completely after receiving this treatment combination. Doctors will use imaging scans to check the size of the tumors and determine whether the treatment is working. The study will also track how long patients live, how long the cancer stays under control without getting worse, and how long any positive response to the treatment lasts. Additionally, the study will monitor how long patients can maintain a response where their cancer is either shrinking, disappearing, or staying stable.

Throughout the study, doctors will carefully watch for any side effects or unwanted reactions that patients may experience from the medications. The severity of these side effects will be recorded and graded according to a standard system used in cancer research. The study will also ask patients questions about their quality of life to understand how the treatment affects their daily activities and overall well-being. Patients will need to have tumor tissue samples available for testing, and they must have measurable disease that can be tracked on scans. The study requires patients to be healthy enough to participate, with adequate blood cell counts, liver function, and kidney function.

1 Initial assessment and baseline evaluation

Upon joining the study, baseline assessments will be performed to evaluate your current health status.

Your disease will be measured according to RECIST 1.1 criteria, which is a standard method for measuring tumors using imaging scans.

Blood tests will be conducted to check blood cell counts, liver function, and kidney function.

Tumor tissue samples (either previously collected or new samples) will be tested for specific markers.

Quality of life questionnaires will be provided to complete, assessing your overall well-being and health status.

2 Treatment with enfortumab vedotin and avelumab

Treatment will consist of two medications administered through an intravenous infusion (directly into a vein).

The first medication is enfortumab vedotin, given as a solution for infusion.

The second medication is avelumab, administered as a concentrate for solution for infusion at a concentration of 20 mg per milliliter.

Both medications will be given in repeated treatment cycles.

The treatment will continue as long as it remains effective and side effects remain manageable.

3 Regular monitoring and follow-up visits

Regular follow-up visits will be scheduled throughout the treatment period.

During these visits, your response to treatment will be assessed using imaging scans to measure any changes in tumor size.

Blood tests will be repeated regularly to monitor blood cell counts, liver function, and kidney function.

Your physical condition will be evaluated using the ECOG performance status, which is a scale that measures how the disease affects daily living abilities.

Any side effects or health changes will be documented and graded according to standard criteria.

4 Quality of life assessments

Throughout the study, questionnaires will be provided at specific intervals to assess quality of life.

These will include the EQ-5D-5L questionnaire, which evaluates mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.

The EQ-HWB-S questionnaire will also be completed, along with additional questions related to your health and well-being.

Responses to these questionnaires will help evaluate how the treatment affects daily life and overall health status.

5 Safety monitoring

Throughout the treatment period, any adverse events will be carefully monitored and recorded.

Side effects will be graded according to CTCAE version 5.0, which is a standardized system for classifying the severity of side effects.

Both common side effects and serious adverse events will be documented.

If significant side effects occur, treatment adjustments may be made as necessary.

6 Response evaluation

The response to treatment will be evaluated by measuring changes in tumor size using imaging scans.

Responses will be classified as complete response (disappearance of all tumors), partial response (significant shrinkage of tumors), stable disease (no significant change), or progressive disease (growth of tumors).

The time from the start of treatment until disease progression or other specified events will be recorded.

Disease control will be assessed at 12 weeks and beyond.

7 Contraception requirements during treatment

If your partner is of childbearing potential, an effective method of contraception must be used during the study period.

Contraception must continue for 4 months after the last dose of enfortumab vedotin or for at least 30 days after the last dose of avelumab, whichever occurs last.

This requirement is in place to prevent potential risks to pregnancy during and after treatment.

8 Long-term follow-up

After completing the treatment phase, follow-up visits will continue to monitor long-term outcomes.

Overall survival, defined as the time from the start of treatment to death from any cause, will be tracked.

The duration of response, if treatment was effective, will be measured from the first documented response until disease progression.

Continued monitoring will assess any delayed side effects and long-term health status.

Who Can Join the Study?

You must be able to understand and willing to sign a written informed consent form, which is a document that explains the study details before you agree to participate.
You must be at least 18 years old or older at the time of signing the consent form.
You must be male with a confirmed diagnosis of penile squamous cell carcinoma, which is a type of cancer affecting the penis, confirmed by examining tissue under a microscope.
Your cancer must be considered not suitable for surgery that could cure the disease. You can join the study if you have cancer that has spread to distant parts of the body, or if you have cancer that has grown deeply into tissues, involves lymph nodes in the groin area on one or both sides, or has spread to lymph nodes in the pelvis.
Tissue samples from your tumor must be available for testing, either from previous biopsies or current samples, to check for certain markers.
Your general physical condition must be rated as 2 or better on the ECOG performance status scale, which measures how the disease affects your daily living abilities, with 0 being fully active and higher numbers indicating more limitations.
You must have disease that can be measured using imaging scans according to specific criteria called RECIST 1.1.
You must not have received any previous systemic treatment for your advanced or metastatic cancer in the palliative setting, which means treatment aimed at controlling symptoms rather than curing. However, if you received treatment before or after surgery more than 6 months ago without immunotherapy, you may still be eligible.
Your blood tests must show adequate function with enough white blood cells, platelets, and red blood cells, and your liver and kidney must be working well enough based on specific laboratory values.
You must not have any other active cancer within the past 3 years, except for certain types of skin cancer that have been adequately treated.
You must not have a history of significant heart disease, such as heart attack or unstable chest pain, within the last 6 months.
Your life expectancy must be at least 3 months.
You must be willing to follow all study requirements, including attending follow-up visits and undergoing required procedures.
If you have a female partner who can become pregnant, you must agree to use effective contraception, which means birth control methods, during the study and for 4 months after the last dose of one study drug or at least 30 days after the last dose of the other study drug, whichever is later.

Who Cannot Join the Study?

Women cannot participate in this study because the trial is only for male patients
Children and adolescents under 18 years old cannot participate in this study
Patients who do not have locally advanced (cancer that has spread to nearby tissues) or metastatic (cancer that has spread to other parts of the body) penile squamous cell carcinoma (a type of skin cancer affecting the penis) cannot participate

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Rostock University Medical Center	Rostock	Germany

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Uwpcflkypobnvjyeohnry Dolfamcwlos Abe	Duesseldorf	Germany
Ktsvmfnv dwb Uyjwsggistyb Mamtnpeg Ang	Munich	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.09.2025

Trial locations

Investigated drugs:

Enfortumab vedotin is a targeted cancer medication that works by attaching to specific proteins found on cancer cells and delivering a cell-killing substance directly into those cells. This helps destroy cancer cells while limiting damage to healthy cells in the body.

Avelumab is an immunotherapy medication that helps your immune system recognize and fight cancer cells. It works by blocking a protein that prevents your immune system from attacking the cancer, allowing your body’s natural defenses to work more effectively against the tumor.

Investigated diseases:

Penile squamous cell carcinoma

Penile Squamous Cell Carcinoma – This is a type of cancer that develops in the skin cells of the penis. The disease begins when squamous cells, which are flat cells that make up the outer layer of the skin, start to grow abnormally and form a tumor. In its early stages, the cancer is confined to the surface layers of the penile tissue. As the disease progresses, it can grow deeper into the tissues of the penis and may spread to nearby lymph nodes in the groin area. In advanced stages, the cancer can spread beyond the local area to distant parts of the body, which is called metastatic disease. When the cancer has grown significantly in the original location or has spread to other organs, it is referred to as locally advanced or metastatic penile squamous cell carcinoma.

Trial ID:

2025-521644-37-00

Protocol code:

UKT-IKF-DEPECA-1

NCT ID:

NCT07110038

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of enfortumab vedotin and avelumab for patients with advanced or metastatic penile cancer that has spread or cannot be removed by surgery

What is this study about?

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