Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

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

Fast replyRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

11 criteria

  • 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 trial?

3 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

  • Carboplatin

    This medication is administered intravenously and is used in combination with other drugs for treating various cancers. It is well-established in medical literature as a chemotherapy agent. Carboplatin is primarily indicated for the treatment of locoregionally advanced penile cancer, among other cancers. It works by interfering with the DNA of cancer cells, preventing them from dividing and growing. It belongs to the pharmacological class of platinum-based antineoplastic agents.

  • Paclitaxel

    Administered intravenously, paclitaxel is a chemotherapy drug used in combination with other medications to treat different types of cancer. It is widely recognized in medical literature for its effectiveness. The main therapeutic indication includes locoregionally advanced penile cancer. Paclitaxel acts by stabilizing the microtubule polymer and protecting it from disassembly, which inhibits cell division. It is classified as a mitotic inhibitor.

  • Pembrolizumab

    This medication is given as an intravenous infusion and is used in cancer immunotherapy. It is well-documented in medical literature and is used for various cancers, including locoregionally advanced penile cancer. Pembrolizumab works by blocking a protein called PD-1, which helps the immune system recognize and attack cancer cells. It is classified as a monoclonal antibody and immune checkpoint inhibitor.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506731-15-00Protocol codeN22APCEstimated enrolment37 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).