Not recruiting

Study of Pembrolizumab and Lenvatinib for Patients with Advanced Non-Clear Cell 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 Non-clear Cell Renal Cell Carcinoma. The trial is investigating the effects of two medications: Pembrolizumab and Lenvatinib. Pembrolizumab is given as an infusion, which means it is administered directly into the bloodstream through a vein, while Lenvatinib is taken orally in the form of capsules. The purpose of the study is to evaluate how well these medications work together in treating this specific type of kidney cancer.

Participants in the study will receive both Pembrolizumab and Lenvatinib as their first treatment for advanced or metastatic Non-clear Cell Renal Cell Carcinoma. The study will monitor how the cancer responds to the treatment over time. This includes checking if the cancer shrinks or disappears and how long any positive effects last. The study will also track the overall health and survival of participants, as well as any side effects they may experience from the treatment.

The trial will continue for a set period, during which participants will regularly visit the study site for treatment and assessments. These assessments will help researchers understand the effectiveness and safety of the combination of Pembrolizumab and Lenvatinib in treating this type of kidney cancer. The information gathered from this study may contribute to future treatment options for patients with Non-clear Cell Renal Cell Carcinoma.

The research process

The trial runs in 5 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 verifying a diagnosis of non-clear cell renal cell carcinoma and ensuring adequate organ function.
A review of medical history and current health status is performed. Blood pressure must be adequately controlled, and a performance status assessment is conducted to ensure it is 70% or higher.
Step 2
Treatment initiation
The treatment phase begins with the administration of two medications: lenvatinib and pembrolizumab.
Lenvatinib is taken orally in the form of capsules. The specific dosage and frequency will be provided by the healthcare team.
Pembrolizumab is administered through an intravenous infusion. The healthcare team will provide details on the dosage and schedule.
Step 3
Ongoing treatment and monitoring
Regular monitoring is conducted to assess the response to treatment. This includes imaging tests and other evaluations to measure disease progression.
Participants are required to attend scheduled visits for treatment administration and health assessments. The frequency of these visits will be communicated by the healthcare team.
Step 4
Response evaluation
The response to treatment is evaluated using specific criteria to determine the effectiveness of the medications.
The primary goal is to assess the objective response rate, which measures the percentage of participants with a significant reduction in tumor size.
Step 5
Completion of treatment
Upon completion of the treatment period, a final assessment is conducted to evaluate overall health and treatment outcomes.
Participants may be required to continue follow-up visits to monitor long-term effects and overall survival.

Who can join the trial?

10 criteria

Must have a diagnosis of non-clear cell renal cell carcinoma (a type of kidney cancer).
Must have adequate organ function (organs like the liver and kidneys are working well enough).
Must have locally advanced or metastatic disease (cancer that has spread to other parts of the body).
Must not have received any previous treatment for advanced non-clear cell renal cell carcinoma. Previous treatment is okay if it was completed more than 12 months ago.
Male participants must agree to use approved birth control methods during the study and for at least 7 days after the last dose of study medication, or agree not to have heterosexual intercourse during this time.
Female participants must not be pregnant or breastfeeding. If they can have children, they must agree to use birth control during the study and for at least 120 days after the last dose of pembrolizumab, or 30 days after the last dose of lenvatinib, whichever is later.
Must have measurable disease (tumors that can be measured) as assessed by a review process. Tumors in areas that have been treated with radiation can be measured if they have grown.
Must provide a sample of tumor tissue, either from a previous surgery or a new biopsy (a small sample of tissue taken from the body).
Must have a Karnofsky Performance Status of 70% or higher (a score that measures the ability to perform daily activities).
Must have controlled blood pressure, with or without medication.

Who cannot join the trial?

10 criteria

Patients with any other type of cancer besides Non-clear Cell Renal Cell Carcinoma cannot participate.
Patients who have had another cancer within the last 5 years, except for certain skin cancers or in situ cancers, are excluded.
Patients with active infections that require treatment are not eligible.
Patients with significant heart problems, such as heart failure or a recent heart attack, cannot join the study.
Patients with uncontrolled high blood pressure are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients with known allergies to the study drugs, pembrolizumab or lenvatinib, are not eligible.
Patients who have received another investigational drug within the last 4 weeks are excluded.
Patients with a history of certain autoimmune diseases, where the immune system attacks the body, cannot participate.
Patients with brain metastases, which are cancer cells that have spread to the brain, are not eligible unless they have been treated and are stable.

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Verified sites

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

Centre Francois Baclesse
Verified
Caen, France
Centre Hospitalier Lyon Sud
Verified
Pierre Benite, France
Fondazione I.R.C.C.S. Istituto Neurologico Besta
Verified
Milan, Italy

Trial locations

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Investigated drugs

Pembrolizumab
is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, pembrolizumab is used to treat a type of kidney cancer that has spread to other parts of the body. The goal is to see if it can help shrink the tumors or slow their growth.
Lenvatinib
is a medication that targets specific proteins in cancer cells, which can help stop the cancer from growing and spreading. It is used in combination with pembrolizumab in this trial to treat advanced kidney cancer. The combination aims to enhance the effectiveness of the treatment by attacking the cancer in different ways.

What is already known about the treatment

Pembrolizumab
Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic non-clear cell renal cell carcinoma, a type of kidney cancer. The main therapeutic use of pembrolizumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-1 on immune cells, which helps the immune system to better detect and destroy cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.
Lenvatinib
Lenvatinib is taken orally in the form of a capsule, which means it is swallowed and absorbed through the digestive system. It is being investigated in clinical trials for its role in treating advanced or metastatic non-clear cell renal cell carcinoma. The main therapeutic indication for lenvatinib is to inhibit the growth of cancer cells and reduce the blood supply to tumors. On a molecular level, lenvatinib works by blocking certain proteins called tyrosine kinases, which are involved in the growth and spread of cancer cells. It is classified as a tyrosine kinase inhibitor, a type of medication that targets specific enzymes involved in cancer cell proliferation.

Investigated diseases

Non-clear Cell Renal Cell Carcinoma – Non-clear cell renal cell carcinoma is a type of kidney cancer that originates in the renal cortex, but unlike the more common clear cell type, it does not have clear cells. This cancer can include several subtypes, such as papillary, chromophobe, and collecting duct carcinoma, each with distinct cellular characteristics. The disease typically begins with abnormal growth of cells in the kidney, forming a mass or tumor. As it progresses, the tumor may grow larger and potentially spread to nearby tissues or other parts of the body. Symptoms may include blood in the urine, a palpable mass in the abdomen, or pain in the side or back. The progression and behavior of the disease can vary significantly depending on the specific subtype and individual patient factors.