Recruiting

Study of Cabozantinib and Durvalumab for Patients with Advanced Bladder Cancer After Chemotherapy

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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 the effects of a combination treatment for patients with advanced bladder cancer, specifically those who have already undergone chemotherapy. The diseases being studied include both urothelial and non-urothelial types of bladder cancer. The treatment involves two medications: Cabozantinib, which is taken as a tablet, and Durvalumab (also known as MEDI4736), which is given as an infusion. The purpose of the study is to see if using these two drugs together is more effective than using them separately.

Participants in the study will receive both Cabozantinib and Durvalumab. The study will monitor how well the combination works in treating the cancer and will also look at the overall survival of the patients. The trial will take place over a period of time, during which patients will be regularly assessed to track their response to the treatment. Some patients may receive a placebo as part of the study to compare the effects of the actual treatment.

The study aims to provide valuable information on whether this combination treatment can improve outcomes for patients with advanced bladder cancer. By participating, patients will contribute to research that could lead to better treatment options in the future. The trial is designed to ensure the safety and well-being of all participants, with regular check-ups and monitoring throughout the study period.

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 provide written informed consent, confirming understanding and agreement to participate in the trial.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes verifying the failure of 1 or 2 cisplatin-based chemotherapy regimens and ensuring adequate organ function.
The patient must be able to swallow tablets and meet specific health criteria, such as a body weight over 30 kg and a life expectancy of at least 12 weeks.
Step 3
Treatment phase
The treatment involves a combination of two medications: durvalumab and cabozantinib.
Durvalumab is administered as an infusion. The specific dosage and frequency will be determined by the healthcare provider.
Cabozantinib is taken orally in the form of film-coated tablets. The dosage includes 40 mg and 20 mg tablets, with the frequency and duration specified by the healthcare provider.
Step 4
Monitoring and follow-up
Throughout the trial, the patient's health and response to treatment will be closely monitored. This includes regular assessments of overall survival and response rates.
The study aims to evaluate the effectiveness of the medication combination compared to single-agent treatments.
Step 5
Completion of the trial
The trial is expected to conclude by January 1, 2025. Upon completion, the patient's overall health and treatment outcomes will be reviewed.

Who can join the trial?

22 criteria

Provide written informed consent, which means you agree to participate after understanding the study details.
Have tried 1 or 2 chemotherapy treatments based on a drug called cisplatin for cancer that has spread, and these treatments did not work. This should be your second or third treatment attempt.
If you had chemotherapy before or after surgery, it counts if the cancer came back within 6 months after the last treatment cycle.
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Your organs must be working well, which includes:
- Enough white blood cells (absolute neutrophil count) of at least 1500 per cubic millimeter.
- Enough platelets, which help with blood clotting, of at least 100,000 per cubic millimeter.
- Hemoglobin, a protein in red blood cells, of at least 9 grams per deciliter.
- Liver enzymes (ALT and AST) should be less than 3 times the normal upper limit.
- Total bilirubin, a substance made by the liver, should be 1.5 times or less the normal upper limit. If you have Gilbert’s disease, it should be 3 milligrams per deciliter or less.
- Serum creatinine, a waste product in the blood, should be 2 times or less the normal upper limit, or your kidney function should be at least 30 milliliters per minute.
- Lipase, an enzyme that helps digest fats, should be less than 2 times the normal upper limit.
- Any side effects from previous treatments should be back to normal or mild, unless they are not significant and stable with treatment.
- You must be able to swallow tablets.
- If you are sexually active and can have children, you and your partner must use contraception. It's recommended to use a barrier method, like a condom, along with hormonal contraceptives.
- If you are a woman who can have children, you need to show proof of menopause or have a negative pregnancy test.
- You must be at least 18 years old.
- Your body weight must be more than 30 kilograms (about 66 pounds).
- You must have a confirmed diagnosis of bladder cancer or a similar type, but not pure small cell carcinoma.
- The cancer can be in the bladder, urethra, or upper urinary tract.
- You should have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
- You should have a life expectancy of at least 12 weeks.
- Tumor tissue must be available for a specific test called PD-L1 IHC assay.
- Both measurable and non-measurable disease can be included, meaning even if the cancer is only in the bones, you can still participate.

Who cannot join the trial?

1 criterion

Patients with a type of bladder cancer known as **urothelial** or **non-urothelial histology** cannot participate. **Histology** refers to the study of the tissues of the body, and in this context, it means the specific type of bladder cancer.

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Fondazione I.R.C.C.S. Istituto Neurologico Besta
Milan, Italy

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Investigated drugs

Cabozantinib
is a medication used in this trial to treat advanced bladder cancer. It works by blocking certain proteins that help cancer cells grow and spread. By inhibiting these proteins, cabozantinib can slow down or stop the progression of the cancer.
Durvalumab
is another medication used in the trial, which is an immunotherapy drug. It helps the body's immune system recognize and attack cancer cells more effectively. Durvalumab works by blocking a specific protein that prevents the immune system from attacking cancer cells, thereby enhancing the body's natural defenses against the tumor.

What is already known about the treatment

Cabozantinib
This medication is administered orally in the form of a tablet. It is currently being studied in clinical trials for its effectiveness in treating advanced bladder cancer, specifically in patients who have already undergone chemotherapy. Cabozantinib works by inhibiting certain proteins that promote cancer cell growth and blood vessel formation, thereby slowing down the progression of the disease. It is classified as a tyrosine kinase inhibitor, which targets specific enzymes involved in cancer cell proliferation.
Durvalumab
This medication is administered intravenously, typically through an infusion. It is being evaluated in clinical trials for its potential to treat advanced bladder cancer, particularly in patients who have previously received chemotherapy. Durvalumab functions by blocking a protein that prevents the immune system from attacking cancer cells, thereby enhancing the body's natural immune response against the tumor. It belongs to the class of drugs known as immune checkpoint inhibitors, which help the immune system recognize and destroy cancer cells.

Investigated diseases

Bladder Carcinoma – Bladder carcinoma is a type of cancer that begins in the cells of the bladder, which is the organ responsible for storing urine. It can be classified into urothelial and non-urothelial histology, with urothelial being the most common type. The disease often starts in the inner lining of the bladder and can progress to invade deeper layers and surrounding tissues. As it advances, it may spread to nearby lymph nodes and other parts of the body. Symptoms can include blood in the urine, frequent urination, and pain during urination. The progression of the disease can vary, with some cases remaining superficial while others become more invasive.