Study of Pembrolizumab and Lenvatinib for Patients with Advanced Non-Clear Cell Kidney Cancer

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz	Miskolc	Hungary
Lux Med Onkologia Sp. z o.o.	Warsaw	Poland
Orszagos Onkologiai Intezet	Budapest	Hungary
University Of Debrecen	Debrecen	Hungary
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Centre Hospitalier Lyon Sud	Pierre Benite	France
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet	Szolnok	Hungary
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Centre Francois Baclesse	Caen	France
Hhxwukib Vxyv dodcrbcd	Barcelona	Spain
Heaakwvb Udzbxfhyhxrlcs Sukaluflbq &twngqk Hhyzvnx dt Hhuyqntjhtw	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	22.01.2021
Hungary	Not recruiting	22.01.2021
Italy	Not recruiting	22.01.2021
Poland	Not recruiting	22.01.2021
Spain	Not recruiting	22.01.2021

Trial locations

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.

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.

Trial ID:

2023-504944-32-00

Protocol code:

MK-3475-B61

NCT ID:

NCT04704219

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Pembrolizumab and Lenvatinib for Patients with Advanced Non-Clear Cell Kidney Cancer

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