Not recruiting

Study of Pembrolizumab, Lenvatinib, and Belzutifan 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 pembrolizumab (also known as Keytruda), lenvatinib, quavonlimab, favezelimab, MK-4830, and belzutifan. These medications are used in different combinations to explore their effects on the disease. Some of these medications are given as a solution for infusion, which means they are administered directly into the bloodstream through a vein, while others are taken orally as capsules or tablets.

The purpose of the study is to assess the safety and effectiveness of these treatment combinations. The study is divided into two phases. The first phase focuses on understanding the safety and tolerability of the treatments, which means checking how well patients can handle the medications and identifying any side effects. The second phase evaluates how well the treatments work in reducing the size of the cancer or stopping its growth. This is done by observing the response of the cancer to the treatments over time.

Participants in the study will receive one or more of the medications, or a placebo, and will be monitored for any side effects and changes in their cancer. The study aims to find the best dose and combination of these treatments to help manage renal cell carcinoma effectively. The trial will continue until the estimated end date in 2025, with ongoing assessments to ensure the safety and well-being of the participants.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant is confirmed to have a diagnosis of locally advanced or metastatic clear cell renal cell carcinoma (ccRCC).
The participant must not be pregnant or breastfeeding and must meet specific health criteria, including controlled blood pressure and adequate organ function.
Step 2
Safety lead-in phase
This phase assesses the safety and tolerability of the treatment combinations.
Participants receive treatment combinations that have not been evaluated in a separate study to establish a recommended dose for the next phase.
Step 3
Efficacy phase
This phase evaluates the safety and effectiveness of each treatment arm.
The objective response rate is assessed by an independent review based on specific criteria.
Step 4
Medication administration
Participants receive pembrolizumab through intravenous infusion as a solution for infusion.
Participants take lenvatinib orally in capsule form.
Other medications such as MK-1308A, MK-4830, MK-4280A, and belzutifan are administered either intravenously or orally, depending on the specific treatment arm.
Step 5
Monitoring and evaluation
Participants are monitored for any adverse events or dose-limiting toxicities.
The duration of response, progression-free survival, and overall survival are evaluated as part of the study's secondary endpoints.
Step 6
Completion of study
The study is estimated to end by September 7, 2025.
Participants are expected to follow the study protocol until the completion of the trial or until they discontinue due to adverse events.

Who can join the trial?

10 criteria

The patient must have a confirmed diagnosis of a type of kidney cancer called clear cell renal cell carcinoma that is either locally advanced or has spread to other parts of the body.
If the patient is a woman, she must not be pregnant or breastfeeding. If she can have children, she must either not be having sex with men or be using birth control during the study and for a certain period after the last dose of the study drugs.
The patient must have experienced worsening of their disease after receiving a specific type of treatment for their kidney cancer, which includes a drug that targets a protein called PD-(L)1. This treatment must have been given either alone or with another drug that targets blood vessel growth in tumors.
The patient must have experienced worsening of their disease after receiving a treatment that targets blood vessel growth in tumors, given either alone or with a PD-(L)1 drug.
The patient must be able to swallow pills.
The patient must have organs that are working well enough.
If the patient is receiving treatment to prevent bone loss, this treatment must have started at least two weeks before joining the study.
The patient must have recovered from any side effects of previous treatments to a mild level.
The patient must have blood pressure that is well controlled, with no recent changes in blood pressure medication.
If the patient is a man, he must either not be having sex with women or agree to use birth control during the study and for a short period after the last dose of certain study drugs.

Who cannot join the trial?

8 criteria

Patients with other types of cancer besides renal cell carcinoma cannot participate. Renal cell carcinoma is a type of kidney cancer.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent situation, are not eligible.
Patients who have participated in other clinical trials that might interfere with this study are not eligible.
Patients with certain medical conditions or taking medications that could interfere with the study treatment are not eligible.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients with a history of severe allergic reactions to any of the study medications are not eligible.
Patients with uncontrolled medical conditions that could affect their safety or the study results are not eligible.

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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

Lenvatinib
is a medication used in this trial to help stop the growth of cancer cells. It works by blocking certain proteins that cancer cells need to grow and spread. This medication is often used in combination with other treatments to enhance its effectiveness.
Pembrolizumab
is an immune therapy that helps the body's immune system recognize and attack cancer cells. It works by blocking a specific protein that prevents the immune system from attacking cancer cells, allowing the immune system to better target and destroy them.
Belzutifan
is a medication that targets specific pathways in cancer cells to stop their growth. It is used in this trial to see if it can effectively slow down or stop the progression of cancer when used in combination with other therapies.

What is already known about the treatment

KEYMAKER-U03 – This medication is administered as part of a clinical trial for renal cell carcinoma, focusing on immune and targeted combination therapies. Currently, it is in the investigational stage, being evaluated for safety, tolerability, and efficacy in treating this type of cancer. The main therapeutic indication is renal cell carcinoma, a type of kidney cancer. The mechanism of action involves modulating the immune system and targeting specific cancer pathways to inhibit tumor growth. It falls under the pharmacological classification of immune and targeted therapies.

Investigated diseases

Renal Cell Carcinoma – This is a type of kidney cancer that begins in the lining of the small tubes in the kidney. It is the most common type of kidney cancer in adults. The disease often grows as a single mass within the kidney, but it can sometimes be found in more than one part of the kidney or in both kidneys at the same time. As it progresses, the cancer can spread to nearby tissues and organs, including the lungs, bones, and liver. Symptoms may include blood in the urine, a lump in the abdomen, or unexplained weight loss. The progression of the disease can vary, with some tumors growing slowly over time while others may grow more rapidly.