Not recruiting

Study of Sacituzumab Govitecan for Patients with Muscle-Invasive Bladder Cancer Unable or Unwilling to Use Cisplatin-Based Chemotherapy

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 treatment for muscle-invasive bladder cancer, a type of cancer that affects the bladder muscles. The treatment being tested is called sacituzumab govitecan, which is given as an infusion through a vein. This study is designed for patients who cannot receive or choose not to have a common chemotherapy treatment known as cisplatin-based chemotherapy.

The purpose of the study is to see if sacituzumab govitecan can help achieve a complete response, meaning no cancer cells are found in the bladder after surgery. Participants in the study will receive the treatment before undergoing a surgery called radical cystectomy, which involves removing the bladder. The study will monitor the effects of the treatment and any side effects that may occur.

Throughout the study, researchers will evaluate how well the treatment works and how safe it is for patients. They will look at the number of patients who have a complete response and also check for any adverse events, which are unwanted effects from the treatment. The study aims to provide more information on the effectiveness and safety of sacituzumab govitecan for patients with muscle-invasive bladder cancer who are not candidates for cisplatin-based chemotherapy.

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
Joining the study
Upon joining the study, you will be required to provide written informed consent, confirming your understanding and agreement to participate in the clinical trial.
You will need to confirm your eligibility, which includes being over 18 years of age and having a diagnosis of muscle-invasive bladder cancer.
Step 2
Initial assessments
Before starting the treatment, you will undergo several assessments to confirm your health status. These may include imaging tests like CT or MRI scans, and PET/CT scans to determine the stage of your cancer.
Blood tests will be conducted to ensure adequate blood counts and liver function. A pregnancy test will be required for women of childbearing potential.
Step 3
Treatment administration
You will receive the medication sacituzumab govitecan, which is administered as an intravenous infusion. This means the medication will be given through a vein in your arm.
The dosage and frequency of the medication will be determined by the study protocol, and you will be informed about the schedule and duration of the treatment.
Step 4
Monitoring and follow-up
Throughout the treatment, regular monitoring will be conducted to assess your response to the medication and to check for any side effects.
You will have scheduled visits for follow-up assessments, which may include additional imaging tests and blood work.
Step 5
Surgery preparation
If the treatment is successful, you will be prepared for a surgical procedure called radical cystectomy, which involves the removal of the bladder.
Further instructions and preparations for the surgery will be provided by your healthcare team.
Step 6
Post-treatment evaluation
After the surgery, a detailed evaluation will be conducted to determine the effectiveness of the treatment.
The primary goal is to achieve a complete pathological response, meaning no viable cancer cells are found in the tissue removed during surgery.

Who can join the trial?

14 criteria

Participants must be female or male and over 18 years of age.
Participants must be able to understand and give written consent to join the study.
Male participants must agree to use a reliable method of birth control from the start of the study until three months after the last dose of the study medication.
Participants must have a clinical stage of T2-T4N0M0 disease, which is determined by a CT or MRI scan and a PET/CT scan within four weeks before joining the study.
Participants must agree to undergo a surgery called radical cystectomy, which involves removing the bladder.
Participants must either be unable to receive or choose not to receive a type of chemotherapy called cisplatin-based chemotherapy before surgery.
Participants must have a confirmed diagnosis of urothelial carcinoma, a type of bladder cancer. If the cancer has mixed cell types, at least 50% must be of the transitional cell type.
Participants must be fit and planned for the surgery according to local guidelines.
Participants must have an ECOG performance status score of 0 or 1, which indicates they are fully active or have some symptoms but do not require bed rest.
Participants must have adequate blood counts without needing blood transfusions or growth factor support within two weeks before starting the study medication. This includes hemoglobin levels of at least 9 g/dL, an absolute neutrophil count (ANC) of at least 1,500/mm³, and platelet counts of at least 100,000/μL.
Participants must have adequate liver function, with bilirubin levels of 1.5 times the upper limit of normal or less, and AST and ALT levels of 2.5 times the upper limit of normal or less, or 5 times the upper limit if there are known liver metastases. Serum albumin must be greater than 3 g/dL.
Participants must have a creatinine clearance of at least 30 mL/min, which is a measure of kidney function, calculated using the Cockcroft-Gault equation.
Female participants of childbearing potential must have a negative pregnancy test within 72 hours before receiving the first dose of the study medication and must not be breastfeeding. If the urine test is positive or unclear, a blood test will be required.
Female participants of childbearing potential must agree to use two methods of birth control, be surgically sterile, or abstain from heterosexual activity during the study and for six months after the last dose of the study medication. Participants of childbearing potential are those who have not been surgically sterilized or have not been without menstrual periods for more than two years.

Who cannot join the trial?

7 criteria

Patients who have any other type of cancer that is not muscle-invasive bladder cancer.
Patients who are currently receiving or have received cisplatin-based chemotherapy for their bladder cancer.
Patients who have a serious infection or illness that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have a history of severe allergic reactions to similar drugs.
Patients who have participated in another clinical trial within the last 30 days.
Patients who have any condition that the study doctors believe would make it unsafe for them to participate.

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Verified sites

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Ospedale San Raffaele S.r.l.
Verified
Milan, Italy

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Investigated drugs

Sacituzumab Govitecan is a type of cancer treatment that combines an antibody with a chemotherapy drug. The antibody part of the medication helps to find and attach to cancer cells, specifically targeting a protein that is often found in high amounts on the surface of certain cancer cells. Once attached, the chemotherapy part of the medication is delivered directly to the cancer cells, helping to kill them. This targeted approach aims to reduce the growth of cancer and is being studied for its effectiveness in treating muscle-invasive bladder cancer, especially in patients who cannot or choose not to receive traditional chemotherapy treatments like cisplatin.

Sacituzumab Govitecan

What is already known about the treatment

Sacituzumab Govitecan – Sacituzumab govitecan is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating muscle-invasive bladder cancer, particularly for patients who cannot receive or choose not to undergo cisplatin-based chemotherapy. The medication works by targeting a specific protein on cancer cells and delivering a toxic substance to kill these cells. It is classified as an antibody-drug conjugate, which combines an antibody with a chemotherapy drug to specifically target and destroy cancer cells.

Investigated diseases

Muscle-invasive bladder cancer – Muscle-invasive bladder cancer is a type of bladder cancer where the cancer cells have grown into the muscle layer of the bladder wall. This progression makes it more aggressive than non-muscle-invasive forms. The disease often begins in the cells lining the bladder and can spread to nearby tissues and organs. As it advances, it may cause symptoms such as blood in the urine, frequent urination, and pain during urination. The cancer can also spread to lymph nodes and other parts of the body. The progression of the disease can vary, with some cases advancing more rapidly than others.