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Study of Cabozantinib for Patients with Advanced Renal Cell Carcinoma After Checkpoint Inhibitor Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of kidney cancer known as Renal Cell Carcinoma (RCC), specifically when it is advanced and cannot be removed by surgery. The study is for patients whose cancer has worsened after initial treatment with medications called checkpoint inhibitors. The treatment being tested in this study is a medication called Cabozantinib, which is taken as a tablet. Cabozantinib is also known by its code name, XL-184.

The purpose of the study is to evaluate how effective and safe Cabozantinib is when used as a second treatment option for this type of kidney cancer. Participants in the study will take Cabozantinib tablets by mouth. The study will observe how the cancer responds to the treatment over time. Some participants may receive a placebo, which is a tablet that looks like the medication but does not contain the active substance. The study will last for a period of time, during which participants will have regular check-ups to monitor their health and the progress of the treatment.

Throughout the study, the response of the cancer to Cabozantinib will be assessed using specific criteria to determine if the treatment is working. The study aims to provide valuable information on whether Cabozantinib can be a beneficial treatment option for patients with advanced Renal Cell Carcinoma who have not had success with their first line of treatment. Participants will be closely monitored to ensure their safety and to gather data on the effectiveness of the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will begin the process by providing a signed informed consent. This is a necessary step before any study-related procedures can commence.
Step 2
Medication administration
The patient will receive cabozantinib, which is administered orally in the form of film-coated tablets. The available dosages are 20 mg, 40 mg, and 60 mg. The specific dosage and frequency will be determined by the study protocol and the patient's condition.
Step 3
Treatment duration
The treatment with cabozantinib will continue as a second-line therapy for patients with unresectable, locally advanced, or metastatic renal cell carcinoma with a clear-cell component. The duration of the treatment will be based on the patient's response and the study's guidelines.
Step 4
Monitoring and evaluation
Throughout the study, the patient's response to the treatment will be monitored using the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. This evaluation will be conducted by an independent central review to assess the objective response rate (ORR).
Step 5
Follow-up
After completing the treatment phase, the patient will undergo follow-up evaluations as specified in the study protocol. These evaluations are necessary to monitor the patient's health and any long-term effects of the treatment.

Who can join the trial?

15 criteria

You must sign a form to show you agree to take part in the study before any study-related activities begin.
If you are a woman who can have children, you and your partner must use very effective birth control methods during the study and for 120 days after the last dose of the study treatment.
If you are a man, you must agree not to donate sperm or have unprotected sex with female partners during the study and for 120 days after the last dose of the study treatment.
You must be willing and able to follow the study rules, stay at the study site for each visit, and return for follow-up checks as needed.
If you are a French participant, you must have social security coverage or be a beneficiary of such a system.
You must be 18 years or older on the day you sign the consent form.
You must have a confirmed diagnosis of a type of kidney cancer that cannot be removed by surgery, is locally advanced, or has spread to other parts of the body, and includes a clear-cell component.
Your cancer must have gotten worse after the first treatment with certain drugs called checkpoint inhibitors, either alone or with another type of therapy targeting blood vessels.
You must have at least one tumor that can be measured according to specific criteria used by doctors.
Your overall health status should be good, with an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
If you have had cancer spread to your brain, it must be stable according to your doctor's assessment.
Your organs and bone marrow must be working well, as shown by specific blood and urine tests.
If you had side effects from previous treatments, they must have improved to a mild level or be stable and not significant according to your doctor.
If you had an immune-related side effect from previous treatment, you must have finished any steroid treatment used to manage it.
If you are a woman who can have children, you must have a negative pregnancy test within 7 days before starting the study treatment. If a urine test is not clear, a blood test is required.

Who cannot join the trial?

6 criteria

Patients who have a type of kidney cancer that cannot be removed by surgery, has spread to other parts of the body, or is locally advanced, and has a clear-cell component, but have not yet received treatment with checkpoint inhibitors.
Patients who have not shown progression after the first line of treatment with checkpoint inhibitors, which are drugs that help the immune system fight cancer.
Patients who have not been treated with a combination of checkpoint inhibitors like ipilimumab and nivolumab, or checkpoint inhibitors combined with VEGF-targeted therapy, which is a treatment that targets blood vessels that supply the tumor.
Patients who are not within the specified age range for the study.
Patients who do not meet the gender criteria, as the study includes both male and female participants.
Patients who are part of a vulnerable population that the study does not include.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Institut Gustave Roussy
Villejuif, France
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Medizinische Hochschule Hannover
Hanover, Germany
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Technische Universitaet Dresden
Dresden, Germany

Trial locations

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Investigated drugs

Cabozantinib is a medication used in this clinical trial as a second-line treatment for patients with advanced kidney cancer that cannot be surgically removed. It is specifically for those who have already been treated with checkpoint inhibitors. Cabozantinib works by blocking certain proteins that promote cancer cell growth, helping to slow down or stop the progression of the disease.

Cabozantinib

What is already known about the treatment

Cabozantinib – This medication is administered orally in the form of a tablet. It is currently being studied as a second-line treatment for patients with advanced renal cell carcinoma, specifically those who have not responded to initial treatments involving checkpoint inhibitors. Cabozantinib is primarily used to treat certain types of cancer by inhibiting the activity of specific proteins that promote cancer cell growth and blood vessel formation. It works at the molecular level by blocking the action of tyrosine kinases, which are enzymes involved in the signaling pathways that regulate cell division and survival. Cabozantinib is classified as a tyrosine kinase inhibitor in pharmacology.

Investigated diseases

Renal Cell Carcinoma – This is a type of kidney cancer that begins in the lining of the small tubes in the kidney. It is characterized by the presence of cancerous cells in the renal cortex, often with a clear-cell component. The disease can be locally advanced, meaning it has spread to nearby tissues, or metastatic, indicating it has spread to other parts of the body. Progression occurs when the cancer grows or spreads despite initial treatment, such as with checkpoint inhibitors. This type of carcinoma is often resistant to first-line treatments, necessitating further therapeutic strategies. The disease's progression is typically monitored through imaging and clinical evaluations.