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Study on the Safety and Effectiveness of Pembrolizumab for Patients with Kidney Cancer After Surgery

Fast replyRegistered 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 renal cell carcinoma. The study is investigating the use of a medication called pembrolizumab, which is also known by its code name MK-3475. Pembrolizumab is a treatment given through an intravenous infusion, meaning it is delivered directly into the bloodstream. The purpose of the study is to evaluate the safety and effectiveness of pembrolizumab as a treatment option for patients who have had surgery to remove kidney cancer.

Participants in the study will receive either pembrolizumab or a placebo. The study will monitor how long participants remain free of cancer after treatment, which is referred to as disease-free survival. Additionally, the study will look at overall survival, which measures how long participants live after starting the treatment. The study will also track any side effects experienced by participants and whether any participants stop the treatment due to side effects.

The study will take place over a period of time, with participants receiving treatment and being monitored for changes in their health. Regular assessments will be conducted to check for any recurrence of cancer and to evaluate the overall health and quality of life of the participants. The study aims to provide valuable information on the potential benefits of pembrolizumab for patients with renal cell carcinoma following surgery.

The research process

The trial runs in 4 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, participants will be randomly assigned to receive either the study medication or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

  2. Step 2

    Treatment administration

    Participants will receive the study medication, pembrolizumab, or a placebo through an intravenous infusion. This involves receiving the medication directly into the bloodstream through a vein.

    The dosage of pembrolizumab is 25 mg/mL, and it will be administered as a solution for infusion. The frequency and duration of administration will be determined by the study protocol and communicated by the study team.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants will undergo regular monitoring and assessments to evaluate their health and the effects of the treatment. This may include physical exams, blood tests, and imaging scans such as CT or MRI.

    The primary goal is to assess disease-free survival, which means the length of time participants remain free from cancer after treatment.

  4. Step 4

    Follow-up

    After completing the treatment phase, participants will continue to be monitored for any changes in their health status. This follow-up period is crucial for understanding the long-term effects of the treatment.

    Participants may be asked to return for periodic check-ups and assessments as part of the study's follow-up protocol.

Who can join the trial?

11 criteria

  • Must have a confirmed diagnosis of renal cell carcinoma (RCC) with a clear cell component, which may or may not have sarcomatoid features.
  • Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest during the day.
  • Must have adequate organ function, meaning your organs are working well enough to participate in the study.
  • Female participants who can have children must agree to use a reliable method of birth control during the study and for 120 days after the last dose of the study treatment.
  • Male participants who can father children must agree to use a reliable method of birth control starting with the first dose of study treatment and continuing for 120 days after the last dose.
  • Must have intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by specific medical criteria related to tumor size, grade, and spread.
  • Must not have received any previous systemic therapy for advanced RCC, which means no treatments that affect the entire body, like chemotherapy.
  • Must have had a nephrectomy (surgery to remove a kidney) or a metastasectomy (surgery to remove cancer spread) with no cancer left at the edges of the removed tissue.
  • Must have had the surgery at least 28 days before signing the consent form and no more than 12 weeks before being randomly assigned to a treatment group.
  • Must be tumor-free as confirmed by a doctor and validated by a CT or MRI scan of the brain, chest, abdomen, and pelvis, and a bone scan within 28 days of being randomly assigned to a treatment group.
  • Must have provided adequate tissue samples from surgery for study purposes, depending on the type of surgery and cancer spread.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer besides renal cell carcinoma (a type of kidney cancer) cannot participate.
  • Patients who have had another cancer within the last 5 years, except for certain skin cancers or in situ cancers (cancers that have not spread), are excluded.
  • Patients with an active infection that requires treatment with antibiotics, antivirals, or antifungals cannot join the study.
  • Patients with an autoimmune disease (a condition where the immune system attacks the body) that requires treatment are not eligible.
  • Patients who have received a live vaccine within 30 days before the start of the study cannot participate.
  • Patients who are pregnant or breastfeeding are excluded from the study.
  • Patients with a history of severe allergic reactions to any of the study drugs or their ingredients cannot join.
  • Patients with a known history of HIV, hepatitis B, or hepatitis C infections are not eligible.
  • Patients who have had major surgery within 4 weeks before starting the study are excluded.
  • Patients who are currently participating in another clinical trial or have done so within the last 4 weeks cannot participate.
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Investigated drugs

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. In this trial, pembrolizumab is being tested to see if it can help prevent the return of kidney cancer after surgery. It is given to patients who have had their kidney tumor removed to see if it can stop or slow down the cancer from coming back.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into a vein through a needle. It is currently being studied in a Phase 3 clinical trial for its effectiveness in treating renal cell carcinoma, a type of kidney cancer, after surgical removal of the kidney. The main therapeutic use of pembrolizumab in this trial is to prevent cancer from returning. At the molecular level, pembrolizumab works by blocking a specific protein on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.

Investigated diseases

Renal cell carcinoma – Renal cell carcinoma is a type of kidney cancer that begins in the lining of the small tubes in the kidney. It typically starts as a single mass or tumor in one kidney, but it can also occur in both kidneys simultaneously. As the disease progresses, the tumor may grow larger and invade nearby tissues or spread to other parts of the body, such as the lungs, bones, or liver. The cancer cells can also enter the bloodstream or lymphatic system, facilitating further spread. Symptoms may include blood in the urine, a lump in the abdomen, or persistent pain in the side. The progression of the disease can vary, with some tumors growing slowly while others may advance more rapidly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501251-81-00Protocol codeMK-3475-564Estimated enrolment1 002 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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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).