Study of Pembrolizumab, Belzutifan, and Lenvatinib for Patients with Advanced Clear Cell Renal Cell Carcinoma

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What is this study about?

This clinical trial is focused on studying treatments for advanced clear cell renal cell carcinoma, a type of kidney cancer. The study will explore the effectiveness and safety of different combinations of medications. The medications being tested include Pembrolizumab (also known by its code name MK-3475), Belzutifan (MK-6482), Lenvatinib (MK-7902), and a combination of Pembrolizumab and Quavonlimab (MK-1308A). These treatments are being compared to see which combination works best as a first-line treatment, meaning it is the first treatment given for this type of cancer.

The purpose of the study is to determine which combination of these medications can help patients live longer without their cancer getting worse. Participants will be randomly assigned to receive one of the treatment combinations. Some participants will receive Pembrolizumab with Belzutifan and Lenvatinib, others will receive MK-1308A with Lenvatinib, and another group will receive Pembrolizumab with Lenvatinib. There is also a possibility of receiving a placebo, which is a substance with no active medication, to compare the effects of the actual treatments.

The study will monitor participants over a period to assess how well the treatments work and to check for any side effects. The goal is to find the most effective treatment combination that can help manage the disease and improve the quality of life for those with advanced clear cell renal cell carcinoma. Participants will receive regular check-ups and assessments to track their progress throughout the study.

1 joining the study

Upon joining the study, you will be randomly assigned to one of the treatment groups. This means you will receive a specific combination of medications as part of the trial.

2 treatment group assignment

You may be placed in one of the following groups: Arm A, Arm B, or Arm C. Each group receives different combinations of medications.

3 medication administration

If you are in Arm A, you will receive pembrolizumab through an intravenous infusion, belzutifan as an oral tablet, and lenvatinib as an oral capsule.

If you are in Arm B, you will receive MK-1308A through an intravenous infusion and lenvatinib as an oral capsule.

If you are in Arm C, you will receive pembrolizumab through an intravenous infusion and lenvatinib as an oral capsule.

4 medication schedule

The intravenous infusion of pembrolizumab or MK-1308A will be administered at the study site. The frequency and duration of these infusions will be explained to you by the study team.

The oral medications, belzutifan and lenvatinib, will be taken at home. The study team will provide instructions on how often and how long you need to take these medications.

5 regular check-ups

You will have regular check-ups with the study team to monitor your health and the effects of the treatment. These check-ups may include physical exams, blood tests, and imaging tests.

6 reporting side effects

It is important to report any side effects or changes in your health to the study team immediately. This helps ensure your safety and the success of the study.

7 end of treatment

At the end of the treatment period, you will have a final evaluation to assess your response to the treatment. The study team will discuss the results with you and provide any necessary follow-up care.

Who Can Join the Study?

The patient must have a confirmed diagnosis of clear cell renal cancer. This means that a doctor has determined the patient has this specific type of kidney cancer.
The patient must not have received any previous treatment for advanced clear cell renal cancer. This means they have not been treated with drugs or therapies for this advanced stage of cancer.
Male patients must either not engage in sexual intercourse with women or agree to use birth control during the study and for at least 7 days after the last dose of the study drugs belzutifan and lenvatinib.
Female patients must not be pregnant or breastfeeding. They must either be unable to become pregnant or agree to use a highly effective birth control method or not engage in sexual intercourse with men during the study and for a certain period after the last dose of the study drugs. This period is at least 120 days after receiving pembrolizumab or pembrolizumab/quavonlimab, or at least 30 days after the last dose of lenvatinib or belzutifan, whichever is longer.
The patient must have adequately controlled blood pressure. This means their blood pressure is at a safe level, with or without medication.
The patient must have adequate organ function. This means their organs, like the liver and kidneys, are working well enough to participate in the study.
If the patient is receiving treatment to prevent bone loss, this treatment must have started at least 2 weeks before joining the study.

Who Cannot Join the Study?

Patients with any other type of cancer besides clear cell renal cancer cannot participate.
Patients who have had another cancer within the last 5 years, except for skin cancer that is not melanoma, cannot participate.
Patients who have had a major surgery within the last 4 weeks cannot participate.
Patients who have an active infection that requires treatment with antibiotics cannot participate.
Patients who have a known allergy to the study medication or its ingredients cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of heart problems, such as heart attack or heart failure, cannot participate.
Patients who have uncontrolled high blood pressure cannot participate.
Patients who have a history of bleeding disorders cannot participate.
Patients who are currently participating in another clinical trial cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Clinico San Carlos	Madrid	Spain
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Oslo Universitetssykehus HF	Oslo	Norway
Klinički bolnički centar Zagreb (University Hospital Center Zagreb)	Zagreb	Croatia
Kuopio University Hospital	Kuopio	Finland
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland

Other Sites

Site Name	City	Country
Hopital Tenon	Paris	France
University Of Debrecen	Debrecen	Hungary
University Hospital Ostrava	Ostrava	Czechia
Beaumont Hospital	Dublin	Ireland
Odense University Hospital	Odense	Denmark
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Karolinska University Hospital	Solna	Sweden
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Turku University Hospital	Turku	Finland
Nemocnice AGEL Novy Jicin a.s.	Novy Jicin	Czechia
Sykehuset Oestfold HF Kalnes	Graalum	Norway
Region Joenkoepings Laen	Jönköping	Sweden
KBC Split	Split	Croatia
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Polyclinique De Limoges	Limoges	France
KBC Zagreb	Zagreb	Croatia
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Orszagos Onkologiai Intezet	Budapest	Hungary
University Teaching Hospital Markusovszky	Szombathely	Hungary
Sørlandet sykehus Kristiansand	Kristiansand	Norway
Fakultni Thomayerova nemocnice	Prague	Czechia
Adelaide And Meath Hospital	Dublin	Ireland
Tampere University Hospital	Tampere	Finland
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Clinique Ambroise Pare	Beuvry	France
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Lux Med Onkologia Sp. z o.o.	Warsaw	Poland
University Hospital Olomouc	Olomouc	Czechia
Kliniki Neuroradiochirurgii Sp. z o.o.	Radom	Poland
Spitalul De Oncologie Monza S.R.L.	Bucharest	Romania
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Charite Research Organisation GmbH	Berlin	Germany
St. Olavs Hospital HF	Trondheim	Norway
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet	Szolnok	Hungary
Bekes Varmegyei Koezponti Korhaz	Gyula	Hungary
University Hospital Consorziale Policlinico	Bari	Italy
Ivcloynm Pqridtjazezslan Cejcka Cccorf	Marseille	France
Fkfnlyak nfdstvrwi Mtsrv a Hqhwhtp	Prague	Czechia
Heteiw Hsumzjcl	Herlev	Denmark
Aantvxtd Ucfxjygcvc Hwkvowpq	Lorenskog	Norway
Uvdhohh Ugmxxpuoua Hfactgas	Uppsala	Sweden
Hqrmt Bnuimh Hp	Bergen	Norway
Hrhermod Ugcaxxovat Cfxdnvv Hsnbzdlx	Helsinki	Finland
Sfuxsxguphf Ugfgtebitw Hcvkiimkdoueknn Guomcmafnxbemxvvl	Gothenburg	Sweden
Hfjwhqqi Ugybowpyvjdbz Mzcpvqo Dj Vcermtwhao	Santander	Spain
Ifuopkny Ckanwm Degxskusnpsqrxmcu	L'hospitalet De Llobregat	Spain
Cjknur Hpsxoxgbapo Rzyvdjma Dmgnswcbehuifq	Angers	France
Bckfvawuyfn Vedmeryzf Oekcmywkpaui	Kecskemet	Hungary
Hjsjzp Khmljmst Syqzxwyj Gkti	Schwerin	Germany
Bmvbutwv Uzprwppsrm Hgjgrxwu Ccfxte	Besançon	France

Trial status

Country	Status	Recruitment Start
Croatia	Not recruiting	21.04.2021
Czechia	Not recruiting	21.04.2021
Denmark	Not recruiting	21.04.2021
Finland	Not recruiting	21.04.2021
France	Not recruiting	21.04.2021
Germany	Not recruiting	21.04.2021
Hungary	Not recruiting	21.04.2021
Ireland	Not recruiting	21.04.2021
Italy	Not recruiting	21.04.2021
Norway	Not recruiting	21.04.2021
Poland	Not recruiting	21.04.2021
Romania	Not recruiting	21.04.2021
Spain	Not recruiting	21.04.2021
Sweden	Not recruiting	21.04.2021

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. This medication is often used to treat various types of cancer, including advanced kidney cancer, by blocking a specific protein that prevents the immune system from doing its job effectively.

Belzutifan is a medication that targets a specific pathway in cancer cells, which is important for their growth and survival. By blocking this pathway, Belzutifan can help slow down or stop the growth of cancer cells. It is used in combination with other treatments to enhance their effectiveness in treating advanced kidney cancer.

Lenvatinib is a medication that works by blocking certain proteins that help cancer cells grow and spread. It is used to treat various types of cancer, including advanced kidney cancer. By interfering with these proteins, Lenvatinib can help slow down the progression of the disease.

MK-1308A is an investigational medication being studied for its potential to treat advanced kidney cancer. It is designed to work with the immune system to help it better recognize and attack cancer cells. This medication is being tested in combination with other treatments to see if it can improve outcomes for patients with this type of cancer.

Clear cell renal cell carcinoma – This is a type of kidney cancer that originates in the lining of the small tubes in the kidney. It is characterized by the presence of clear cells when viewed under a microscope. The disease often begins as a small mass in the kidney and can grow over time. As it progresses, it may invade nearby tissues and spread to other parts of the body, such as the lungs, bones, or liver. The growth and spread of the cancer can lead to symptoms such as blood in the urine, pain in the side or back, and a lump in the abdomen. The progression of the disease can vary greatly among individuals.

Trial ID:

2022-502122-41-00

Protocol code:

MK-6482-012

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Pembrolizumab, Belzutifan, and Lenvatinib for Patients with Advanced Clear Cell Renal Cell Carcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?