Study Comparing Nivolumab and Cabozantinib with Sunitinib for Patients with Untreated Advanced Kidney Cancer

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What is this study about?

This clinical trial is focused on studying advanced or metastatic renal cell carcinoma, a type of kidney cancer that has either progressed to an advanced stage or spread to other parts of the body. The study aims to evaluate the safety and effectiveness of a combination treatment using Nivolumab and Cabozantinib compared to another medication called Sunitinib. Nivolumab is a medication that helps the immune system fight cancer, while Cabozantinib and Sunitinib are drugs that target specific proteins in cancer cells to stop their growth.

The purpose of this study is to determine whether the combination of Nivolumab and Cabozantinib is more effective and safe compared to Sunitinib in treating patients who have not received any prior treatment for their advanced or metastatic kidney cancer. Participants in the study will be randomly assigned to receive either the combination treatment or Sunitinib. The study will monitor the participants over a period to assess the progression of the disease and any side effects experienced.

Throughout the study, participants will receive their assigned treatment and undergo regular check-ups to track their health and the cancer’s response to the treatment. The study will help researchers understand which treatment option provides better outcomes for patients with this type of kidney cancer. A placebo may be used in some parts of the study to compare the effects of the actual medications. The study is expected to continue until 2025, providing valuable insights into the treatment of advanced or metastatic renal cell carcinoma.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of advanced or metastatic renal cell carcinoma with a clear-cell component.

The assessment ensures no prior systemic therapy for renal cell carcinoma, except for specific cases of adjuvant or neoadjuvant therapy.

2 randomization

Participants are randomly assigned to one of two treatment groups. This process is essential to compare the effectiveness of the treatments without bias.

3 treatment administration – nivolumab and cabozantinib

Participants in the first group receive nivolumab and cabozantinib. Nivolumab is administered as a solution for infusion, which means it is given intravenously.

Cabozantinib is provided in the form of film-coated tablets for oral use. The specific dosage and frequency are determined by the study protocol.

4 treatment administration – sunitinib

Participants in the second group receive sunitinib. This medication is provided as hard capsules for oral use.

The dosage and frequency of sunitinib are specified in the study protocol.

5 monitoring and follow-up

Throughout the study, participants undergo regular monitoring to assess the treatment’s effectiveness and safety.

This includes tracking progression-free survival, overall survival, and response rates, as well as recording any adverse events.

6 study completion

The study is estimated to conclude by March 31, 2025. At this point, all data will be analyzed to determine the safety and effectiveness of the treatments.

Who Can Join the Study?

The patient must have a confirmed diagnosis of Renal Cell Carcinoma (RCC), which is a type of kidney cancer. The cancer should have a clear-cell component, which is a specific type of cell found in this cancer. It can also have sarcomatoid features, which means the cancer cells look like a type of tissue called sarcoma.
The cancer must be advanced, meaning it cannot be cured with surgery or radiation, or it must be metastatic, which means it has spread to other parts of the body.
The patient should not have received any previous systemic therapy for RCC. Systemic therapy is treatment that affects the whole body, like chemotherapy. There is an exception if the patient had one previous treatment after surgery to remove the cancer, as long as it did not include drugs targeting VEGF (a protein that helps cancer grow) or its receptors, and the cancer came back at least 6 months after the last treatment.
Both men and women can participate in the study.
The study does not include vulnerable populations, which means people who might need special protection or care.

Who Cannot Join the Study?

Patients who have received previous treatment for their kidney cancer.
Patients with other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have allergies to the study medications.
Patients with a history of another type of cancer, unless it has been successfully treated and is not expected to come back.
Patients with active infections that require treatment.
Patients with certain heart conditions that could be affected by the study medications.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who are participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
University Hospital Jena KöR	Jena	Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Euromedica General Clinic Of Thessaloniki	Thessaloniki	Greece
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej	Biala Podlaska	Poland
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Alexandra Hospital	Athens	Greece
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
University Hospital Olomouc	Olomouc	Czechia
Azienda USL Toscana Sud Est	Arezzo	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy
Hhawjrlq Uantynkjysgci Metefik Dw Vzqvumpbui	Santander	Spain
Hwuzskfr Vqyv dzqjspmk	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	02.10.2017
Germany	Not recruiting	02.10.2017
Greece	Not recruiting	02.10.2017
Italy	Not recruiting	02.10.2017
Poland	Not recruiting	02.10.2017
Romania	Not recruiting	02.10.2017
Spain	Not recruiting	02.10.2017

Trial locations

Investigated drugs:

Nivolumab is a medication used in this trial to help the immune system attack cancer cells. It works by blocking a protein that stops the immune system from working properly, allowing it to better target and destroy cancer cells.

Cabozantinib is another medication in the trial that helps to slow down or stop the growth of cancer cells. It works by blocking certain proteins that cancer cells need to grow and spread.

Sunitinib is a medication used as a comparison in this trial. It is designed to block proteins that help cancer cells grow and spread, and it is commonly used to treat kidney cancer.

Investigated diseases:

Metastatic renal cell carcinoma

Advanced or Metastatic Renal Cell Carcinoma – This is a type of kidney cancer that has progressed to an advanced stage or has spread to other parts of the body. It originates in the lining of the small tubes in the kidney and can grow into a large mass. As the disease advances, it may invade nearby tissues and organs, and cancer cells can travel through the bloodstream or lymphatic system to distant sites. Symptoms may include blood in the urine, pain in the side or back, and a lump in the abdomen. The disease can also cause fatigue, weight loss, and fever. The progression of the disease varies, and it can affect individuals differently.

Trial ID:

2023-509711-83-00

Protocol code:

CA209-9ER

NCT ID:

NCT03141177

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Nivolumab and Cabozantinib with Sunitinib for Patients with Untreated Advanced Kidney Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?