Study of Belzutifan with Lenvatinib versus Cabozantinib in Adults with Advanced Renal Cell Carcinoma Who Have Previously Received Anti-PD-1/L1 Treatment

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What is this study about?

This clinical trial focuses on treating advanced renal cell carcinoma (a type of kidney cancer) that has clear cell features and has gotten worse after previous treatment. The study tests two different treatment approaches. The first approach combines two medications: belzutifan and lenvatinib. The second approach uses a single medication called cabozantinib. These medications are taken by mouth in the form of tablets or capsules.

The purpose of this study is to compare how well these two treatment approaches work in people whose cancer has progressed after receiving a specific type of immunotherapy (anti-PD-1/L1 therapy). The study will measure which treatment is better at stopping the cancer from growing and helping patients live longer.

During the study, participants will be randomly assigned to receive either the combination of belzutifan and lenvatinib or cabozantinib alone. The treatment will continue for up to 46 months, as long as it is working and the side effects are manageable. Throughout the study, doctors will regularly check the participants’ health and monitor how their cancer responds to the treatment.

1 Initial evaluation

Your eligibility for the study will be assessed based on having advanced renal cell carcinoma (kidney cancer) with clear cell component

Your medical history will be reviewed, particularly previous treatments with anti-PD-1/L1 therapy

Your blood pressure and overall physical condition will be evaluated

Your organ function will be assessed through medical tests

2 Treatment assignment

You will be randomly assigned to one of two treatment groups:

Group 1: Combination of belzutifan (tablets) and lenvatinib (capsules) taken by mouth

Group 2: Cabozantinib taken by mouth

3 Treatment period

You will take the assigned medication orally according to the prescribed schedule

Regular assessments will be conducted to monitor your tumor response using imaging scans

Your health status and any side effects will be monitored throughout the treatment

Treatment will continue until disease progression or other stopping criteria are met

4 Safety monitoring

Regular medical check-ups will be performed to monitor your health

Any side effects or adverse events will be recorded and assessed

Blood pressure and organ function will be monitored regularly

You may need to use appropriate birth control methods during treatment and for a specified period afterward (30-120 days depending on treatment group)

5 Follow-up period

Your health status will continue to be monitored after treatment completion

Regular assessments will track your cancer progression status

The study is expected to continue until February 2026

Who Can Join the Study?

  • You must have advanced kidney cancer (specifically clear cell renal cell carcinoma) that cannot be surgically removed or has spread to other parts of the body
  • Your organs must be functioning properly
  • You must have had your cancer progress during or after treatment with immunotherapy (anti-PD-1/L1 therapy), either as initial treatment or after surgery
  • Your cancer must be measurable using special imaging techniques
  • You must have good physical function, with a Karnofsky performance score of at least 70% (able to care for yourself but unable to carry out normal activities)
  • You must have received no more than 2 previous cancer treatments
  • You must have received only 1 previous immunotherapy treatment
  • Your blood pressure must be well controlled
  • If you are a male participant, you must agree to use contraception during treatment and for at least 7 days after the last dose
  • If you are a female participant, you must not be pregnant or breastfeeding, and either:
    • Be unable to have children, or
    • Agree to use contraception during treatment and for at least 30-120 days after the last dose, depending on treatment group

Who Cannot Join the Study?

  • Prior treatment with belzutifan (a medication that targets cancer cells) or cabozantinib (a type of targeted therapy)
  • Active brain metastases (cancer that has spread to the brain)
  • Severe heart conditions, including:
    • Uncontrolled high blood pressure
    • Heart attack within the last 6 months
    • Unstable heart rhythm problems
  • Severe liver problems or abnormal liver function tests
  • Known HIV infection
  • Active hepatitis B or C infection
  • Other active cancers requiring treatment (except for certain skin cancers or early-stage cancers that have been successfully treated)
  • Major surgery within 3 weeks before starting the study treatment
  • Pregnancy or breastfeeding
  • Unable to swallow oral medications
  • Any serious medical condition that could interfere with study participation or make it unsafe
  • Participation in another clinical trial within 4 weeks before starting this study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oncopole Claudius Regaud Toulouse France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
IRCCS Humanitas Research Hospital Rozzano Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari Italy
Frisius Heerenveen The Netherlands
Medical University Of Vienna Vienna Austria
Hospital Clinico San Carlos Madrid Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Medical University Of Graz Graz Austria
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Haga Hospital Hague The Netherlands
Centre Antoine Lacassagne Nice France
Hopital Tenon Paris France
Institut Jules Bordet Anderlecht Belgium
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Universitair Ziekenhuis Gent Gent Belgium
Azienda Ospedaliera S Maria Di Terni Terni Italy
HELIOS Klinikum Erfurt GmbH Erfurt Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Amphia Hospital Breda The Netherlands
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Grand Hopital De Charleroi Charleroi Belgium
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Martha-Maria Krankenhaus Halle-Doelau gGmbH Halle (Saale) Germany
Institut Godinot Reims France
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
Polyclinique De Limoges Limoges France
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Turku University Hospital Turku Finland
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
General University Hospital Of Patras Patras Greece
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Azienda USL Toscana Sud Est Arezzo Italy
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Netherlands Cancer Institute Amsterdam The Netherlands
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Fakultni Thomayerova nemocnice Prague Czechia
Institut de Cancérologie de l’Ouest Saint-Herblain France
Cdjixnjtd Uxeehvhbrvuhfr Socmlpnzx Woluwe-Saint-Lambert Belgium
Opqrhetpsjdkez Lknt Gdsh Linz Austria
Isuyxkax Rclqxcrtf Pop Ln Sktdli Des Tsgjla Dnyq Apyvjpp Ittq Svysml Meldola Italy
Hoiksqdj Ufodwqetnj Cyjgfcl Htpxbfuo Helsinki Finland
Effazbj Ubutpggrsejy Mdzpyfb Cupmruc Rytvboqta (zhkmsxq Mto Rotterdam The Netherlands
Aulute Mknlwrl Cxricf Sbko Thessaloniki Greece
Nkiloxvb Iyeyxpfs Ocxlrlrfs Iks Mfiut Stpqiaioywmnfagzavsjkijjwxcb Ipmbkfnq Bjwsplgt Cracow Poland
Ggqhne Umorudeyli Fztclqvpp Frankfurt Germany
Hviixdyp Dg Lj Sbjgo Cvrw I Smtj Ppd Barcelona Spain
Hsfdgeqb Vzrh drdvvdhh Barcelona Spain
Ueyqaeawmy Gjbfdvl Hrwozqsi Avwcgbj Athens Greece
Hrycgwrh Uparnwpfdetrnx Sqhjqskczh &wqwirp Hamoica dl Hadsqicbbax STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
25.02.2021
Belgium Belgium
Not recruiting
25.02.2021
Czechia Czechia
Not recruiting
25.02.2021
Finland Finland
Not recruiting
25.02.2021
France France
Not recruiting
25.02.2021
Germany Germany
Not recruiting
25.02.2021
Greece Greece
Not recruiting
25.02.2021
Ireland Ireland
Not recruiting
25.02.2021
Italy Italy
Not recruiting
25.02.2021
Poland Poland
Not recruiting
25.02.2021
Romania Romania
Not recruiting
25.02.2021
Spain Spain
Not recruiting
25.02.2021
The Netherlands The Netherlands
Not recruiting
25.02.2021

Trial locations

Belzutifan (also known as MK-6482) is a medication that works by blocking a protein involved in cancer growth. It is being studied as a treatment for advanced kidney cancer in patients whose cancer has progressed after previous immunotherapy treatments.

Lenvatinib (also known as MK-7902) is a medication that helps stop cancer cells from growing and forming new blood vessels. It works by blocking specific proteins that cancer cells need to grow and spread. It is already approved for treating several types of cancer, including kidney cancer.

Cabozantinib is a medication that targets multiple proteins involved in cancer growth and spread. It works by blocking signals that cancer cells use to grow and create new blood vessels. It is currently used to treat advanced kidney cancer and has shown effectiveness in patients who have tried other treatments.

The trial studies the combination of belzutifan and lenvatinib compared to cabozantinib alone in treating advanced kidney cancer (renal cell carcinoma) in patients whose cancer has progressed after receiving a specific type of immunotherapy.

Renal Cell Carcinoma (RCC) – A type of kidney cancer that begins in the lining of small tubes within the kidneys. The clear cell variant is the most common form of RCC, characterized by cells that appear clear or pale when viewed under a microscope. The disease typically develops in the kidney’s outer layer and can grow into a tumor over time. As it advances, the cancer may spread beyond the kidney to nearby lymph nodes or other organs. The clear cell component refers to the specific appearance of the cancer cells when examined in a laboratory.

Trial ID:
2024-510620-39-00
Protocol code:
MK-6482-011
NCT ID:
NCT04586231
Trial Phase:
Therapeutic confirmatory (Phase III)

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