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Study on Pembrolizumab for Patients with Resectable Metastases from Kidney Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying a type of kidney cancer known as oligometastatic renal cell carcinoma. This condition involves a limited number of cancerous growths that have spread from the kidney to other parts of the body. The study is investigating the effectiveness of a treatment called pembrolizumab, which is also known by its brand name, KEYTRUDA. Pembrolizumab is a medication given through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. The purpose of the study is to see if pembrolizumab can help delay the progression of the cancer in patients who are candidates for surgery or radiation therapy to remove or treat these metastases.

Participants in the study will receive pembrolizumab, and some may receive a placebo. The study will compare the outcomes of those who receive pembrolizumab with those who do not, to determine if the medication is effective in extending the time before the cancer progresses. The study will also look at how long patients live after treatment and monitor any side effects that may occur. The trial is expected to continue for several years to gather enough information to make these assessments.

Throughout the study, patients will undergo regular check-ups and imaging tests to monitor the status of their cancer. These tests will help doctors understand how the cancer is responding to the treatment. The ultimate goal is to find out if pembrolizumab can improve the quality of life and survival for patients with this type of kidney 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

    Enrollment

    Participants must be at least 18 years old with a confirmed diagnosis of clear cell renal cell carcinoma.

    Participants should have undergone a partial or complete nephrectomy with no cancer cells at the edges of the removed tissue.

    Participants must have a limited number of metastases that can be treated with surgery or radiotherapy.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of pembrolizumab, a medication given through an intravenous infusion.

    The specific product used is KEYTRUDA 25 mg/mL concentrate for solution for infusion.

  3. Step 3

    Treatment schedule

    Pembrolizumab is administered at regular intervals as determined by the study protocol.

    The duration of the treatment period is aligned with the study's objectives to evaluate the delay in tumor progression.

  4. Step 4

    Monitoring and assessments

    Participants will undergo regular monitoring to assess the response to treatment.

    Assessments include imaging studies to detect any progression of kidney cancer.

  5. Step 5

    Completion and follow-up

    The study aims to evaluate the time until any cancer progression or the appearance of new metastases.

    Participants will be followed up to assess overall survival and any side effects experienced during the trial.

Who can join the trial?

12 criteria

  • Participants must be at least 18 years old and have a confirmed diagnosis of **clear cell renal cell carcinoma**. This is a type of kidney cancer.
  • Participants should have had a **partial nephrectomy** or **radical complete nephrectomy** with no cancer cells left at the edges of the removed tissue. These are surgeries to remove part or all of a kidney.
  • Participants must have **oligo-metastatic disease** that can be treated with local **radiotherapy** or surgery. This means having a small number of cancer spread areas that can be treated.
  • New metastases should have appeared within 5 years after the primary tumor or previous metastases were removed.
  • Participants can have a maximum of 3 metastases in the same or different locations, except for bone metastases, which cannot exceed 2 if they are the only disease site, or 1 if there are multiple sites.
  • Each metastasis should be less than 3 cm in size, and the total size of all tumors should be less than 5 cm.
  • Participants should not have received any previous **systemic therapy** for renal cell carcinoma. This means no treatments that affect the whole body, like chemotherapy.
  • Participants must have an **ECOG performance status** of 0 to 1. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Participants or their legal representatives must provide written consent to participate in the study.
  • Participants must provide a sample of tumor tissue, either from a previous surgery or a new biopsy. A biopsy is a procedure to remove a small piece of tissue for testing.
  • Female participants must not be pregnant or breastfeeding and must agree to use birth control if they are of childbearing potential.
  • Participants must have adequate organ function, meaning their organs are working well enough to participate in the study.

Who cannot join the trial?

15 criteria

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another type of cancer in the past, unless it was treated and has not come back for a certain period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have an allergy to the study medication or similar drugs.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of certain heart problems.
  • Patients who have a history of certain lung problems.
  • Patients who have a history of certain liver problems.
  • Patients who have a history of certain kidney problems.
  • Patients who have a history of certain immune system problems.
  • Patients who have a history of certain mental health problems.
  • Patients who have received certain treatments for cancer recently.
  • Patients who have had a major surgery recently.
  • Patients who have received a live vaccine recently.
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Investigated drugs

Pembrolizumab is a medication used in this clinical trial to help delay the progression of kidney cancer that has spread to other parts of the body. It works by helping the immune system recognize and attack cancer cells more effectively. This treatment is being tested in patients who have a small number of metastases and are candidates for surgery or radiation therapy to remove or treat these metastases.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently well-established in medical literature as an immunotherapy used to treat various types of cancer, including renal cell carcinoma. The main therapeutic indication for pembrolizumab in this context is to delay tumor progression in patients with oligometastatic renal cell carcinoma who are candidates for surgery or radiation therapy. At the molecular level, pembrolizumab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells more effectively. It is classified as a monoclonal antibody and is part of the broader category of immune checkpoint inhibitors.

Investigated diseases

Oligometastatic Renal Cell Carcinoma – This is a type of kidney cancer that has spread to a limited number of other parts of the body. It is characterized by the presence of a few metastatic sites, typically fewer than five. The disease progresses as cancer cells from the kidney travel through the bloodstream or lymphatic system to other organs. These metastases can grow and potentially cause symptoms depending on their location. The progression of the disease can vary, with some patients experiencing slow growth of metastases. Understanding the behavior of these limited metastases is crucial for determining appropriate treatment strategies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512180-31-00Protocol codePE-PEEstimated enrolment81 patientsSponsorConsorzio Oncotech

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