Not recruiting

Study of Pembrolizumab, Favezelimab, and Lenvatinib for Patients with Renal Cell Carcinoma

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 treatments for renal cell carcinoma, a type of kidney cancer. The study involves several medications, including MK-4280A (a combination of pembrolizumab and favezelimab), MK-1308A (a combination of pembrolizumab and quavonlimab), MK-7684A (a combination of pembrolizumab and vibostolimab), lenvatinib, and belzutifan. These treatments are being tested to see how safe and effective they are when used in combination.

The purpose of the study is to evaluate the safety and effectiveness of these treatment combinations. Participants will receive different combinations of the medications, which may be given as a solution for infusion (a liquid given through a vein) or as capsules or tablets taken by mouth. The study will monitor participants for any side effects and measure how well the cancer responds to the treatments.

The study is divided into two phases. The first phase focuses on assessing the safety and tolerability of the treatment combinations. The second phase evaluates the effectiveness of the treatments by looking at how the cancer responds. Participants will be closely monitored throughout the study to ensure their safety and to gather information on how well the treatments work against renal cell carcinoma.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and ensuring the diagnosis of locally advanced or metastatic clear cell renal cell carcinoma.
Participants must have adequate organ function and controlled blood pressure. Any previous therapy-related side effects should be resolved to a mild level.
Step 2
Treatment phase
The treatment phase involves receiving a combination of medications. These include pembrolizumab and favezelimab administered through intravenous infusion, and lenvatinib taken orally as capsules.
The specific dosage and frequency of administration will be determined by the study team based on individual needs and responses.
Step 3
Monitoring and follow-up
Regular monitoring is conducted to assess the safety and tolerability of the treatment. This includes checking for any adverse effects and adjusting treatment as necessary.
Participants will have scheduled visits for physical exams, blood tests, and imaging studies to evaluate the response to treatment.
Step 4
Completion and evaluation
Upon completion of the treatment phase, a final evaluation is conducted to assess the overall response to the therapy.
Participants may be asked to continue follow-up visits to monitor long-term effects and overall health status.

Who can join the trial?

9 criteria

Has a histologically confirmed diagnosis of locally advanced/metastatic clear cell renal cell carcinoma (ccRCC). This means the type of kidney cancer has been confirmed by examining tissue under a microscope.
Has received no prior systemic therapy for advanced RCC. This means no previous treatment that affects the entire body for advanced kidney cancer. Prior treatment given before or after surgery is acceptable if it was completed at least 12 months before joining the study.
Is able to swallow oral medication. This means the participant can take medicine by mouth.
Has adequate organ function. This means the organs are working well enough to participate in the study.
Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks before joining the study. Bone resorptive therapy is treatment to prevent bone loss.
Has resolution of toxic effects of the most recent prior therapy to ≤Grade 1. This means any side effects from previous treatments have improved to a mild level.
Has adequately controlled blood pressure (BP ≤150/90 mm Hg) with no change in hypertensive medications within 1 week before joining the study. This means blood pressure is under control and stable.
Male participants are abstinent from heterosexual intercourse or agree to use contraception during treatment and for at least 7 days after the last dose of certain study drugs. If only receiving specific drugs, no contraception is needed after stopping them.
Female participants must not be pregnant and must not be a woman of childbearing potential, or if they are, they must be abstinent from heterosexual intercourse or using contraception during the study and for a specified time after the last dose of study drugs. They must also abstain from breastfeeding during the study and for a specified time after.

Who cannot join the trial?

10 criteria

Patients with other types of cancer besides renal cell carcinoma cannot participate.
Patients who have not recovered from previous treatments or surgeries are excluded.
Patients with severe heart problems are not eligible.
Patients with uncontrolled high blood pressure cannot join the study.
Patients with active infections, including HIV or hepatitis, are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to similar treatments are not eligible.
Patients with brain metastases, which means cancer has spread to the brain, are excluded unless treated and stable.
Patients who have participated in another clinical trial within the last 4 weeks are not eligible.
Patients with autoimmune diseases, where the immune system attacks the body, are excluded.

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Verified sites

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

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands
Institut De Cancerologie De Lorraine
Responsive
Vandoeuvre Les Nancy, France
Universitair Medisch Centrum Utrecht
Responsive
Utrecht, The Netherlands

Trial locations

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Investigated drugs

Immune Therapy
is a type of treatment that helps your body's own immune system fight cancer. It works by boosting the natural defenses of your body to find and attack cancer cells more effectively. This therapy is often used in combination with other treatments to improve its effectiveness.
Targeted Therapy
is a treatment that uses drugs or other substances to precisely identify and attack cancer cells, usually while doing little damage to normal cells. It targets specific molecules involved in the growth and spread of cancer. This approach helps to block the growth and spread of cancer by interfering with specific molecules that are involved in the progression of the disease.

What is already known about the treatment

KEYMAKER-U03 – This medication is administered as part of a clinical trial for renal cell carcinoma, a type of kidney cancer. It is currently being studied to determine its safety, tolerability, and effectiveness in combination with other therapies. The main goal is to see how well it works in shrinking tumors and managing the disease. The medication works by targeting specific pathways in cancer cells to stop their growth and spread. It belongs to a class of drugs known as targeted therapies, which are designed to attack cancer cells more precisely than traditional chemotherapy.

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 progresses by forming a mass or tumor in the kidney, which can grow and potentially spread to other parts of the body. As the disease advances, it may invade nearby tissues and organs, and in some cases, metastasize to distant sites such as the lungs, bones, or liver. The progression of renal cell carcinoma can vary, with some tumors growing slowly over time, while others may be more aggressive. Symptoms may not appear until the disease is advanced, and can include blood in the urine, a lump in the abdomen, or unexplained weight loss. The disease is often detected incidentally during imaging tests for other conditions.