Study of Pembrolizumab and Axitinib Combination Versus Sunitinib for Patients with Advanced or Metastatic 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 metastatic renal cell carcinoma. The study is investigating the effectiveness and safety of a combination treatment using two medications, pembrolizumab and axitinib, compared to a single medication called sunitinib. Pembrolizumab, also known by its code name MK-3475, is a medication that helps the immune system fight cancer cells. Axitinib and sunitinib are both medications that work by blocking certain proteins that help cancer cells grow.

The purpose of this study is to compare how well patients with advanced kidney cancer respond to the combination of pembrolizumab and axitinib versus those who receive only sunitinib. Participants in the study will be randomly assigned to receive either the combination treatment or the single medication. The study will monitor the participants over a period to see how the cancer responds to the treatments and to check for any side effects.

Throughout the study, participants will receive regular check-ups and assessments to track their health and the progress of their cancer. The study aims to provide valuable information on which treatment option might be more effective for patients with this type of kidney cancer. The trial is expected to continue until the end of 2025, allowing researchers to gather comprehensive data on the treatments’ long-term effects.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive a combination of pembrolizumab and axitinib, while the other group will receive sunitinib alone.

This assignment is random, meaning it is like flipping a coin to decide which treatment you will receive.

2 treatment with pembrolizumab and axitinib

If you are in the group receiving pembrolizumab and axitinib, you will receive pembrolizumab through an intravenous infusion. This means the medication will be given to you directly into a vein through a needle.

You will also take axitinib by mouth in the form of a pill. The specific dosage and frequency will be explained to you by the study team.

3 treatment with sunitinib

If you are in the group receiving sunitinib, you will take this medication by mouth in the form of a pill.

The specific dosage and frequency will be explained to you by the study team.

4 regular check-ups

Throughout the study, you will have regular check-ups to monitor your health and the effects of the treatment.

These check-ups will include physical exams, blood tests, and imaging tests to see how the treatment is working.

5 reporting side effects

It is important to report any side effects or changes in your health to the study team immediately.

The study team will provide guidance on how to manage any side effects you may experience.

6 end of treatment

The treatment will continue until the study ends or until it is no longer beneficial for you.

The study team will discuss the next steps with you as the study comes to an end.

Who Can Join the Study?

Has a confirmed diagnosis of renal cell carcinoma (RCC) with a clear cell component, which may or may not have sarcomatoid features.
Has locally advanced or metastatic disease (meaning the cancer has spread to other parts of the body) or has recurrent disease.
Has measurable disease according to specific medical guidelines assessed by a doctor or radiologist.
Has not received any prior systemic therapy for advanced RCC.
Has provided a sample of tumor tissue, either from a previous sample or a new biopsy of a tumor that has not been treated with radiation.
Has a Karnofsky performance status (KPS) of 70% or higher, which is a measure of the ability to carry out daily activities.
If receiving treatment to prevent bone loss, such as bisphosphonates or RANK-L inhibitors, the treatment must have started at least 2 weeks before joining the study.
Demonstrates adequate organ function, meaning the organs are working well enough to participate in the study.
Male participants who can father children must agree to use a reliable method of birth control from the first dose of the study drug until 120 days after the last dose.
Female participants who can become pregnant must agree to use a reliable method of birth control during the study and for 120 days after the last dose of the study drug.

Who Cannot Join the Study?

Patients with other types of cancer that have spread to other parts of the body cannot participate.
Patients who have had another cancer within the last 5 years, except for certain skin cancers or in situ cancers (cancers that have not spread), are excluded.
Patients with active infections that require treatment with antibiotics, antivirals, or antifungals are not eligible.
Patients with a history of severe allergic reactions to similar drugs used in the study cannot join.
Patients with uncontrolled high blood pressure, which means blood pressure that is not managed by medication, are excluded.
Patients with significant heart problems, such as heart failure or recent heart attacks, cannot participate.
Patients with brain metastases, which means cancer that has spread to the brain, are not eligible unless treated and stable.
Patients who are pregnant or breastfeeding cannot join the study.
Patients who have received another investigational drug within the last 4 weeks are excluded.
Patients with autoimmune diseases, which are conditions where the immune system attacks the body, are not eligible.
Patients with a history of organ transplant cannot participate.
Patients with known HIV, hepatitis B, or hepatitis C infections are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Technische Universitaet Dresden	Dresden	Germany
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Centre Antoine Lacassagne	Nice	France
Orszagos Onkologiai Intezet	Budapest	Hungary
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
HELIOS Klinikum Emil von Behring GmbH	Berlin	Germany
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Fakultni Nemocnice Bulovka	Prague	Czechia
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet	Szolnok	Hungary
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Fakultni Nemocnice Plzen	Plzen	Czechia
University Of Debrecen	Debrecen	Hungary
University Teaching Hospital Markusovszky	Szombathely	Hungary
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet	Budapest	Hungary
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz	Miskolc	Hungary
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
University Hospital Olomouc	Olomouc	Czechia
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hopital Beaujon	Clichy	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Hopital Saint Eloi	Montpellier	France
L’Hopital Prive Du Confluent	Nantes	France
Mater Private Hospital	Dublin	Ireland
Ihudjtlq Misdzafzjq Mxvimqptex	Paris	France
Fjgdlmhv nipadzzmj Mitbm a Hmnpzhg	Prague	Czechia
Cguqgv Hiyojijgasy Eg Uoilhsjathaeg Dj Lccizdx	Limoges	France
Akxrsmupdi Pbceqnep Hqmiqsqm Do Mbssvxgmu	Marseille	France
Uqlsxnhdbgussnvmzzqkw Dgfuoocsgii Auc	Duesseldorf	Germany
Cmdngp Hhscklfupfg Rvgoafvz Uehkoscdmgbnt Dv Tfhlu	Tours	France
Uqiguqlinqbncfnwhbomh Mefnmddo Aeh	Munster	Germany
Njnrlsyr Itcghdxz Oqrpoqeux Imc Mwrkc Sjdgrdwvntlzmhjmcuqarlojzlvk Ippwepoz Bfcntvzg	Cracow	Poland
Hkqwfijl Vjmt dheuzord	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	10.10.2016
France	Not recruiting	10.10.2016
Germany	Not recruiting	10.10.2016
Hungary	Not recruiting	10.10.2016
Ireland	Not recruiting	10.10.2016
Poland	Not recruiting	10.10.2016
Spain	Not recruiting	10.10.2016

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 in combination with another medication to see if it can help treat kidney cancer that has spread to other parts of the body or is locally advanced.

Axitinib is a medication that targets specific proteins in cancer cells, which can help stop the cancer from growing and spreading. It is used in this trial alongside pembrolizumab to see if the combination is more effective than using another treatment alone for kidney cancer.

Sunitinib is a medication that is used on its own in this trial. It works by blocking certain proteins that cancer cells need to grow. The trial is comparing the effectiveness of sunitinib alone to the combination of pembrolizumab and axitinib in treating kidney cancer.

Investigated diseases:

Metastatic renal cell carcinoma

Metastatic renal cell carcinoma – Metastatic renal cell carcinoma is a type of kidney cancer that has spread beyond the kidney to other parts of the body. It originates in the renal cortex, where the kidney’s filtering units are located. The disease progresses as cancer cells travel through the bloodstream or lymphatic system to form secondary tumors in other organs, such as the lungs, bones, or liver. As the cancer spreads, it can cause symptoms like pain, fatigue, and weight loss. The progression of the disease can vary, with some patients experiencing rapid spread while others may have a slower progression. The spread of cancer cells can lead to complications depending on the organs affected.

Trial ID:

2023-507294-18-00

Protocol code:

MK-3475-426

NCT ID:

NCT02853331

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Pembrolizumab and Axitinib Combination Versus Sunitinib for Patients with Advanced or Metastatic Kidney Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?