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Study of Sacituzumab Govitecan for Patients with Advanced or Metastatic Bladder Cancer

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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 treatment for unresectable locally advanced or metastatic urothelial cancer, a type of cancer that affects the bladder and other parts of the urinary system. The treatment being tested is called sacituzumab govitecan, which is administered as a solution for infusion, meaning it is given directly into the bloodstream through a vein. The purpose of the study is to evaluate how well this treatment works in patients with this type of cancer.

Participants in the study will receive the treatment over a period of time, and their response to the treatment will be monitored. The study will look at how the cancer responds to the treatment, including whether it shrinks or stops growing. The study will also assess how long patients live without the cancer getting worse. Some participants may receive other medications as part of their treatment, such as cisplatin, gemcitabine, carboplatin, pembrolizumab (also known as Keytruda), avelumab (also known as Bavencio), domvanalimab (also known as AB154), and zimberelimab (also known as AB122).

The study is designed to gather information on the effectiveness and safety of sacituzumab govitecan in treating this type of cancer. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to collect data on the treatment's impact on their cancer. The study aims to provide valuable insights that could lead to improved treatment options for patients with urothelial cancer.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in the trial
You will receive a medication called sacituzumab govitecan through an intravenous infusion, which is a method of delivering medicine directly into a vein.
The dosage for sacituzumab govitecan is 10 mg per kilogram of your body weight.
Step 2
Combination therapy in cohort 7
In certain parts of the study, specifically cohort 7, sacituzumab govitecan is administered alongside two other medications: enfortumab vedotin and zimberelimab.
enfortumab vedotin is given as an intravenous infusion at a dose of 125 mg.
zimberelimab is given via intravenous administration at a dose of 360 mg.

Who can join the trial?

10 criteria

Must be a female or male who is 18 years or older (19 years or older for South Korea).
Must have locally advanced or metastatic urothelial cancer confirmed by a tissue sample.
Must have a life expectancy of at least 3 months.
Must have an Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest during the day.
Must have adequate kidney and liver function.
Must have adequate blood cell counts without needing blood transfusions.
For certain groups, must have measurable disease by CT or MRI scans, which means the cancer can be measured in size.
For certain groups, must have not received certain treatments before, or must have had specific responses to previous treatments.
For certain groups, must have a creatinine clearance (a measure of kidney function) of at least 30 mL/min, calculated by a specific formula.
For certain groups, must provide a tumor tissue sample from a previous surgery or biopsy.

Who cannot join the trial?

15 criteria

Patients with other types of cancer that are not **urothelial cancer** cannot participate.
Patients who have had another cancer within the last 5 years, except for skin cancer that is not melanoma, cannot participate.
Patients who have had a **heart attack** or other serious heart problems in the last 6 months cannot participate.
Patients with **uncontrolled high blood pressure** cannot participate.
Patients with **active infections** that require treatment with antibiotics cannot participate.
Patients who are **pregnant** or **breastfeeding** cannot participate.
Patients who have received another experimental treatment within the last 4 weeks cannot participate.
Patients with **severe liver disease** cannot participate.
Patients with **severe kidney disease** cannot participate.
Patients with **autoimmune diseases** that require treatment with drugs that suppress the immune system cannot participate.
Patients who have had a **stroke** in the last 6 months cannot participate.
Patients with **brain metastases** that are not stable cannot participate.
Patients who have had a major surgery within the last 4 weeks cannot participate.
Patients with **HIV**, **hepatitis B**, or **hepatitis C** infections cannot participate.
Patients who have a history of **allergic reactions** to similar drugs cannot participate.

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Verified sites

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

Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Institut De Cancerologie De Lorraine
Vandoeuvre Les Nancy, France
Responsive
Istituto Oncologico Veneto
Padua, Italy

Trial locations

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Investigated drugs

Sacituzumab Govitecan is a type of treatment used in this clinical trial for patients with a specific kind of cancer called urothelial cancer, which affects the urinary system. This medication is designed to target and attach to cancer cells, delivering a powerful drug directly to them. The goal is to help shrink the tumors or slow down their growth, making it easier to manage the disease. This treatment is particularly used when the cancer is advanced and cannot be removed by surgery. By focusing on the cancer cells, it aims to reduce the impact on healthy cells, potentially leading to fewer side effects compared to traditional chemotherapy. This trial is exploring how effective this medication is in improving the condition of patients with this type of cancer.

Zimberelimab

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 locally advanced or metastatic urothelial cancer, which is a type of bladder cancer that has spread or cannot be surgically removed. The medication works by delivering a toxic substance directly to cancer cells, using an antibody that specifically targets these cells, thereby helping to kill them while sparing most normal cells. Sacituzumab Govitecan is classified as an antibody-drug conjugate, a type of targeted cancer therapy.

Investigated diseases

Locally Advanced/Metastatic Urothelial Cancer – This is a type of cancer that originates in the urothelial cells lining the bladder and can spread to nearby tissues or distant organs. In its locally advanced stage, the cancer has grown into nearby tissues or lymph nodes but has not spread to distant parts of the body. When it becomes metastatic, the cancer cells have spread to other parts of the body, such as the liver, lungs, or bones. The disease progresses as cancer cells continue to grow and invade other tissues, potentially leading to the formation of new tumors in different locations. The progression can vary greatly among individuals, with some experiencing rapid spread while others may have slower disease advancement. The symptoms and impact on the body depend on the extent and location of the cancer spread.