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

1 1 1 1

What is this study about?

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

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
Oncopole Claudius Regaud Toulouse France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France

Other Sites

Site Name City Country Status
Orszagos Onkologiai Intezet Budapest Hungary
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Netherlands Cancer Institute Amsterdam The Netherlands
Emlpgpg Ujjnmjwnhvrv Myumpah Ctjrkze Ricuwigyt (jddavcb Mfb Rotterdam The Netherlands
Uzlogntclircsq Cmaotxk Kucqdwsso Gdansk Poland
Hjqlhhgd Viqf djjflerb Barcelona Spain
Hfgxgosm Ufhoiqrtqibzrk Scjkwgejhn &xqavpk Hvbyvwt du Hnlwsyzybcp STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
10.12.2020
Hungary Hungary
Not recruiting
10.12.2020
Poland Poland
Not recruiting
10.12.2020
Spain Spain
Not recruiting
10.12.2020
The Netherlands The Netherlands
Not recruiting
10.12.2020

Trial locations

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.

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.

Trial ID:
2023-506838-68-00
Protocol code:
MK-3475-03A
NCT ID:
NCT04626479
Trial Phase:
Human Pharmacology (Phase I) – Other

Other Trials to Consider

  • Belzutifan and Zanzalintinib in Adults with Advanced Renal Cell Carcinoma After PD-1/L1 and VEGF-TKI Therapy

    Recruiting

    3 1 1
    Czechia Denmark France Germany Greece Italy +3
  • A study of belzutifan and lenvatinib for patients with von Hippel-Lindau disease-associated tumors or other specific solid tumors.

    Recruiting

    3 1 1
    Investigated drugs:
    Belgium Czechia Denmark Finland France Germany +4