Study of Cabozantinib for Patients with Advanced Renal Cell Carcinoma Previously Treated with One Immunotherapy Drug

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What is this study about?

This clinical trial is focused on studying a type of kidney cancer known as Renal Cell Carcinoma, specifically in patients whose cancer has spread and who have already been treated with a type of medicine called an immunocheckpoint inhibitor. These inhibitors are drugs that help the immune system recognize and attack cancer cells. The treatment being tested in this study is a medication called Cabozantinib, which is taken by mouth. Cabozantinib is designed to slow down or stop the growth of cancer cells.

The purpose of the study is to see how well Cabozantinib works in patients who have already received one immunocheckpoint inhibitor. Participants in the study will take Cabozantinib and will be monitored to see how their cancer responds to the treatment. The study will also look at how long patients live without their cancer getting worse, which is known as progression-free survival. Additionally, the study will gather information on the overall survival of patients, the response rates to the treatment, and the safety of the drug.

Throughout the study, patients will have regular check-ups and tests to monitor their health and the effects of the treatment. The study aims to provide valuable information on the effectiveness and safety of Cabozantinib for treating advanced kidney cancer in patients who have already tried other treatments. This research could help improve future treatment options for people with this type of cancer.

1 enrollment

Upon joining the study, the patient must provide a signed written informed consent.

Eligibility is confirmed based on specific health criteria, including blood counts, liver function, and kidney function.

The patient must have previously received one treatment with a PD1/PDL1 inhibitor.

2 treatment initiation

The patient begins treatment with cabozantinib, administered orally.

The dosage and frequency of administration are determined by the study protocol and the patient’s specific health needs.

3 treatment duration

The treatment continues until the study’s estimated end date of June 30, 2025, or until the patient experiences disease progression or unacceptable side effects.

Regular monitoring of the patient’s health and response to treatment is conducted throughout the study.

4 monitoring and assessments

The patient’s progression-free survival (PFS) is assessed as the primary endpoint.

Secondary endpoints include overall survival (OS), objective response rates (ORR), and the safety profile of the drug.

Regular assessments are conducted to monitor the patient’s response to treatment and any side effects.

5 completion

Upon completion of the study or withdrawal, the patient may receive follow-up care as needed.

The study aims to provide valuable data on the effectiveness and safety of cabozantinib in treating advanced renal cell carcinoma.

Who Can Join the Study?

You must sign a written informed consent form, which means you agree to participate after understanding the study details.
Your blood test results need to meet certain levels:
- Absolute neutrophil count (a type of white blood cell) should be more than 1.5 x 10⁹ per liter.
- Platelet count (cells that help with blood clotting) should be more than 100 x 10⁹ per liter.
- Hemoglobin (a protein in red blood cells) should be more than 9 grams per deciliter.
- Total bilirubin (a substance made by the liver) should be less than 1.5 times the normal upper limit.
- AST and ALT (liver enzymes) should be less than 2.5 times the normal upper limit if you don’t have liver metastases, and less than 5 times if you do.
- Serum creatinine (a waste product in the blood) should be less than 2.0 milligrams per deciliter.
- Amylase and lipase (enzymes related to digestion) should be less than 1.5 times the normal upper limit.
If you are a woman who can have children, you must not be pregnant at the start of the study.
You must have had one previous cancer treatment with a PD1/PDL1 inhibitor, either alone or with another type of treatment.
You must be 18 years or older.
You must have a diagnosis of clear cell renal cell carcinoma, which is a type of kidney cancer.
You must have a measurable disease, meaning the cancer can be measured and has shown growth in scans.
If you are a woman who can have children or a man who can father children, you must use effective birth control during the study and for 4 months after the last treatment.
All areas of cancer, including those in the brain that are not causing symptoms, must be included.
Your Karnofsky performance status, which measures your ability to perform daily activities, must be 70% or higher.
You must have a life expectancy of more than 3 months.

Who Cannot Join the Study?

Patients who have not been treated with an immunocheckpoint inhibitor. These are medicines that help the immune system fight cancer.
Patients who have not been diagnosed with metastatic clear cell renal cell carcinoma. This is a type of kidney cancer that has spread to other parts of the body.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not considered part of the vulnerable population selected for the study.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	11.06.2018

Trial locations

Investigated drugs:

Cabozantinib

Cabozantinib is a medication used in this trial to treat patients with advanced or unresectable renal cell carcinoma. It works by inhibiting certain proteins that promote cancer cell growth and spread. This medication is being studied to see how well it can stop the progression of cancer in patients who have already been treated with an immunocheckpoint inhibitor.

Immunocheckpoint Inhibitor (anti PD1/PDL1) refers to a type of therapy that helps the immune system recognize and attack cancer cells. These inhibitors block proteins that prevent the immune system from attacking cancer, allowing it to better target and destroy cancer cells. In this trial, patients have already been treated with one of these inhibitors before receiving cabozantinib.

Investigated diseases:

Clear cell renal cell carcinoma

Metastatic Clear Cell Renal Cell Carcinoma – This is a type of kidney cancer that begins in the cells lining the small tubes within the kidney. It is characterized by the spread of cancer cells from the kidney to other parts of the body, which is referred to as metastasis. The disease often progresses as cancer cells grow and form tumors in other organs, such as the lungs, bones, or liver. Patients may experience symptoms like blood in the urine, pain in the side or back, and unexplained weight loss. The progression of the disease can vary, with some patients experiencing rapid growth of tumors, while others may have a slower progression.

Trial ID:

2024-514058-59-00

Protocol code:

BREAKPOINT

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Cabozantinib for Patients with Advanced Renal Cell Carcinoma Previously Treated with One Immunotherapy Drug

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?