#1 Clinical Trials Search in Europe

Study on the Effectiveness of Carboplatin, Paclitaxel, and Pembrolizumab for Patients with Advanced Penile Cancer

2 1 1 1

What is this study about?

This clinical trial is focused on studying the effectiveness of a treatment combination for locoregionally advanced penile cancer. The treatment involves three medications: pembrolizumab, also known by its code name MK-3475, paclitaxel, and carboplatin. These medications are given as solutions through an intravenous infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to assess how well this combination of medications works in treating penile cancer that has spread to nearby areas. Participants in the study will receive the treatment over a period of time, and their response to the treatment will be monitored. The study aims to see if the cancer can be completely removed or reduced significantly. The trial will also look at the safety of the treatment and any side effects that may occur.

Throughout the study, participants will be closely observed to track their progress and any changes in their condition. The study will help researchers understand the potential benefits and risks of using this combination of medications for treating penile cancer. The findings from this study could provide valuable insights into new treatment options for this type of cancer.

1 joining the study

Upon joining the study, the participant provides written informed consent. This confirms understanding and agreement to participate in the trial.

Eligibility is confirmed based on criteria such as age, diagnosis of squamous cell carcinoma of the penis, and disease stage.

2 initial assessment

An initial assessment is conducted to evaluate the participant’s health status. This includes checking the Eastern Cooperative Oncology Group (ECOG) performance status, which measures the ability to perform daily activities.

Adequate organ function is verified through tests, and a tumor tissue sample is provided for analysis.

3 treatment phase

The treatment involves a combination of three medications administered through intravenous infusion.

Pembrolizumab is given as a concentrate for solution for infusion.

Paclitaxel is administered as a concentrate for solution for infusion.

Carboplatin is also given as a concentrate for solution for infusion.

The specific dosage, frequency, and duration of each medication are determined by the study protocol.

4 monitoring and follow-up

Throughout the trial, the participant’s response to treatment is closely monitored. This includes regular health assessments and tests to evaluate the effectiveness of the treatment.

Any side effects or adverse reactions are documented and managed according to the study guidelines.

5 completion of the study

The study is estimated to conclude by June 2026. Upon completion, the participant’s overall health and response to treatment are assessed.

The primary goal is to achieve a pathological complete response, meaning no detectable cancer remains.

Who Can Join the Study?

  • Male patients who are older than 18 years.
  • Must have a confirmed diagnosis of a type of cancer called squamous cell carcinoma of the penis. This means the cancer cells have been identified under a microscope.
  • The patient, or someone legally allowed to make decisions for them, must sign a document agreeing to participate in the trial.
  • Patients must have specific stages of the disease, which include:
    • cTxN2-3: This refers to certain stages of cancer spread to lymph nodes.
    • cTxN1 with specific conditions like central nodal necrosis (dead tissue in the lymph node), an irregular nodal border, or a lymph node larger than 3 cm.
    • Inguinal or pelvic lymph node recurrence that can be surgically removed.
    • Having up to 2 distant metastases (cancer spread to other parts of the body) that can be treated with surgery or radiation.
  • A sample of the tumor tissue must be provided. This can be from a previous sample or a new biopsy, which is a small piece of tissue taken from the tumor.
  • Male participants must agree to use birth control during the study and for at least 180 days after the last treatment. They should also not donate sperm during this time.
  • Must have an ECOG performance status of 0 to 1. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Must have adequate organ function, which means the organs are working well enough to handle the treatment. Tests to check this must be done within 14 days before starting the study treatment.

Who Cannot Join the Study?

  • Patients who do not have locoregionally advanced penile cancer cannot participate. This means the cancer is in the penis and nearby areas but has not spread to distant parts of the body.
  • Only male patients are eligible, so female patients cannot participate.
  • Patients who are considered part of a vulnerable population are not eligible. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as children or those unable to give informed consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Netherlands Cancer Institute Amsterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.06.2024
The Netherlands The Netherlands
Recruiting
01.06.2024

Trial locations

Investigated drugs:

Carboplatin is a chemotherapy medication used to treat various types of cancer. In this trial, it is used to help shrink tumors in patients with advanced penile cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

Paclitaxel is another chemotherapy drug that is used in combination with carboplatin. It helps stop the growth of cancer cells by inhibiting their ability to divide. This medication is part of the treatment plan to improve the effectiveness of the therapy for penile cancer.

Pembrolizumab is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. It is used in this trial to enhance the body’s natural defenses against penile cancer, potentially improving the overall response to treatment.

Investigated diseases:

Locoregionally Advanced Penile Cancer – This is a type of cancer that occurs in the tissues of the penis and has spread to nearby areas but not to distant parts of the body. It typically begins as a small lesion or growth on the skin of the penis, which may be mistaken for a sore or rash. As the disease progresses, it can invade deeper tissues and spread to nearby lymph nodes. Symptoms may include a lump or mass on the penis, changes in skin color, or persistent sores. The progression of the disease can lead to more significant local symptoms and complications if not managed. Understanding the local spread is crucial for determining the appropriate management and intervention strategies.

Trial ID:
2023-506731-15-00
Protocol code:
N22APC
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study on the Use of Indocyanine Green and Technetium (99mTc) Nanocolloid for Sentinel Node Biopsy in Patients with Melanoma, Oral Cancer, or Penile Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Using EMI-137 for Intraoperative Visualization in Patients with Penile and Tongue Cancer

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands