This clinical trial is focused on studying a type of kidney cancer known as renal cell carcinoma (RCC), specifically the clear cell subtype. The study is investigating the effectiveness and safety of a treatment combination involving two medications: Belzutifan (also known by its code name MK-6482) and Pembrolizumab (also known as Keytruda). Belzutifan is taken as a film-coated tablet, while Pembrolizumab is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein. The trial also includes a comparison group that receives a placebo along with Pembrolizumab.
The purpose of the study is to compare how well patients do without the cancer coming back after treatment with Belzutifan plus Pembrolizumab versus those receiving a placebo plus Pembrolizumab. Participants in the study will have undergone surgery to remove the kidney tumor, a procedure known as nephrectomy. The study will follow participants over a period of time to monitor their health and any changes in their condition. The main focus is on how long patients remain free from cancer after treatment, which is referred to as disease-free survival.
Throughout the study, researchers will also look at other important factors, such as overall survival, any side effects experienced by participants, and changes in quality of life. The study aims to provide valuable information on whether the combination of Belzutifan and Pembrolizumab can help prevent the return of renal cell carcinoma after surgery, potentially offering a new treatment option for patients with this type of cancer.
1randomization
Upon joining the study, participants are randomly assigned to one of two groups. One group receives belzutifan plus pembrolizumab, and the other group receives a placebo plus pembrolizumab.
2treatment administration
Participants in the belzutifan group take belzutifan orally in the form of film-coated tablets. The dosage and frequency are determined by the study protocol.
All participants receive pembrolizumab through an intravenous infusion. The dosage is 25 mg/mL, and the frequency and duration are specified by the study protocol.
3monitoring and assessments
Participants undergo regular monitoring to assess their health and the effectiveness of the treatment. This includes physical examinations, blood tests, and imaging studies as required by the study protocol.
Participants are evaluated for disease-free survival (DFS), which is the primary goal of the study. This involves checking for any signs of cancer returning.
4follow-up
After completing the treatment phase, participants continue to be monitored for overall survival and any adverse events. This includes tracking any side effects experienced during the study.
Participants’ quality of life is assessed using questionnaires designed to measure physical and role functioning, as well as disease symptoms.
Who Can Join the Study?
The patient must have a confirmed diagnosis of renal cell carcinoma (RCC), which is a type of kidney cancer, with a clear cell component.
The patient must have a specific risk level of RCC, which can be intermediate-high risk, high risk, or M1 no evidence of disease (NED). This is based on certain tumor characteristics and grading.
The patient must have had a complete removal of the primary tumor through surgery, which can be either partial or complete removal of the kidney (nephrectomy), and any soft tissue metastases in M1 NED cases.
The patient must have had the nephrectomy and/or removal of metastases within 12 weeks before being randomly assigned to a treatment group in the study.
The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which is a scale used to assess how the disease affects the patient’s daily living abilities, within 10 days before randomization.
Male patients must agree to use contraception for at least 7 days after the last dose of the study medication or placebo.
Female patients who can become pregnant must agree to use a reliable method of contraception during the study and for a certain period after the last dose of the study medication or placebo.
The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.
Who Cannot Join the Study?
Participants with any other type of cancer besides renal cell carcinoma (a type of kidney cancer) cannot join the study.
Individuals who are not within the specified age range for the study are excluded.
Participants who are part of a vulnerable population, which means they might need special protection or care, are not eligible.
People who are not able to follow the study procedures or take the study medication as required will be excluded.
Individuals who have any medical condition that the study doctors believe would make it unsafe for them to participate cannot join.
Belzutifan (MK-6482) is a medication being studied for its potential to help prevent the return of cancer in patients who have had surgery to remove kidney cancer. It works by targeting specific pathways in cancer cells that help them survive and grow. In this trial, it is being tested to see if it can improve the time patients remain free of cancer after surgery.
Pembrolizumab (MK-3475) is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. It is already used in the treatment of various types of cancer. In this trial, it is being used in combination with belzutifan to see if the two drugs together can more effectively prevent the return of kidney cancer after surgery.
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 tumor within a kidney, but it can sometimes be found in more than one part of the kidney or in both kidneys. As it progresses, the cancer cells can spread to nearby tissues and organs, including the lungs, bones, and liver. The progression of renal cell carcinoma can vary, with some tumors growing slowly over time, while others may grow more rapidly. The disease is often discovered incidentally during imaging tests for other conditions.
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