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Study on Atezolizumab and Cabozantinib for Patients with Advanced Renal Cell Carcinoma After Tumor Progression Post-Immune Checkpoint Inhibitor Treatment

Verified siteRegistered drugNo placebo

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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). The study is investigating the effectiveness and safety of two treatments: atezolizumab and cabozantinib. Atezolizumab is a medication that helps the immune system fight cancer, while cabozantinib is a drug that blocks certain proteins that promote cancer growth. The trial will compare the combination of atezolizumab and cabozantinib with cabozantinib alone in patients whose cancer has progressed despite previous treatment with immune checkpoint inhibitors.

The purpose of the study is to evaluate how well the combination of atezolizumab and cabozantinib works compared to cabozantinib alone. Participants will receive either the combination treatment or cabozantinib by itself. The study will monitor the participants over a period of time to assess the progression of the cancer and overall survival. The trial will also look at the side effects of the treatments and how they affect the participants' health.

Participants in the study will receive the treatments either as a film-coated tablet taken by mouth or as a solution for infusion, which is administered through a vein. The study aims to provide valuable information on the potential benefits of combining atezolizumab with cabozantinib for patients with advanced kidney cancer. The results could help improve treatment options for those affected by this disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of renal cell carcinoma (RCC) that is either locally advanced or metastatic.
The assessment ensures that the disease has progressed after previous treatment with immune checkpoint inhibitors. A performance status score and adequate organ function are also evaluated.
Step 2
Randomization
Participants are randomly assigned to one of two groups: one receiving a combination of atezolizumab and cabozantinib, and the other receiving cabozantinib alone.
This process ensures that each participant has an equal chance of being placed in either group, which helps in comparing the effectiveness of the treatments.
Step 3
Treatment administration
For those in the combination group, atezolizumab is administered as an intravenous infusion. The dosage is 1,200 mg, given every three weeks.
Participants in both groups receive cabozantinib in the form of film-coated tablets, taken orally. The dosage and frequency are determined by the study protocol.
Step 4
Regular monitoring
Throughout the study, regular monitoring is conducted to assess the progression of the disease and the participant's overall health.
This includes imaging tests to evaluate tumor size, blood tests to monitor organ function, and assessments of any side effects experienced.
Step 5
Evaluation of outcomes
The primary outcomes being measured are progression-free survival and overall survival. These are assessed by an independent review facility.
Secondary outcomes include response rates to the treatment, duration of response, and the incidence of any adverse events.
Step 6
Study completion
The study is estimated to conclude by March 2025. At this point, final evaluations are conducted to determine the overall effectiveness and safety of the treatments.
Participants may be asked to attend a final follow-up visit to discuss the results and any further care needed.

Who can join the trial?

8 criteria

Must have a type of kidney cancer called renal cell carcinoma (RCC), which can be either clear cell or non-clear cell types like papillary, chromophobe, or unclassified. If it's the chromophobe type, it must have a specific feature called sarcomatoid differentiation.
The cancer must be measurable according to specific guidelines used by doctors to assess tumors.
Must have scores from a specific database that helps assess the risk of the kidney cancer spreading.
The cancer must have gotten worse after previous treatment with a type of medicine called an immune checkpoint inhibitor (ICI), which helps the immune system fight cancer.
Must have a Karnofsky Performance Status score of 70 or higher, which means the person can take care of themselves and do normal activities with some effort.
Must have good blood health and organs that are working well enough.
Both men and women can participate.
People who are considered vulnerable can also participate.

Who cannot join the trial?

8 criteria

Patients who have a different type of cancer other than renal cell carcinoma (RCC), which is a type of kidney cancer.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies or reactions to the study medications.
Patients who have a history of certain medical conditions that the study excludes.

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Verified sites

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

Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Verified
Wroclaw, Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Verified
Ulm, Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Verified
Munich, Germany

Trial locations

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Investigated drugs

Atezolizumab
is a medication used in this trial to help the body's immune system attack cancer cells. It is a type of immunotherapy known as a checkpoint inhibitor, which works by blocking a protein that prevents the immune system from attacking cancer cells. In this study, it is being tested in combination with another drug to see if it can improve outcomes for patients with advanced kidney cancer.
Cabozantinib
is a medication that targets specific proteins in cancer cells to stop their growth and spread. It is used in this trial both alone and in combination with atezolizumab to treat patients with advanced kidney cancer. The study aims to determine if the combination of cabozantinib with atezolizumab is more effective than cabozantinib alone.

What is already known about the treatment

Atezolizumab
This medication is administered intravenously and is currently being studied in combination with cabozantinib for treating renal cell carcinoma, particularly in cases where the cancer is inoperable, locally advanced, or metastatic. Atezolizumab is an immune checkpoint inhibitor that works by blocking the PD-L1 protein, helping the immune system to detect and attack cancer cells more effectively. It is classified as a monoclonal antibody and is widely recognized in medical literature for its role in cancer immunotherapy.
Cabozantinib
This medication is taken orally and is being evaluated both alone and in combination with atezolizumab for the treatment of renal cell carcinoma. Cabozantinib is a tyrosine kinase inhibitor that targets multiple pathways involved in tumor growth and angiogenesis, effectively slowing down the progression of cancer. It is classified as a small molecule inhibitor and is well-documented in medical literature for its use in various types of cancer therapy.

Investigated diseases

Renal Cell Carcinoma – Renal cell carcinoma is a type of kidney cancer that begins in the lining of the small tubes in the kidney. It is the most common type of kidney cancer in adults. The disease often grows as a single mass within the kidney, but it can sometimes be found in more than one part of the kidney or in both kidneys. As it progresses, it may spread to nearby lymph nodes and other organs, such as the lungs or bones. Symptoms may not appear in the early stages, but as the tumor grows, it can cause blood in the urine, pain in the side, or a lump in the abdomen. The progression of the disease can vary, with some tumors growing slowly and others more rapidly.