Study of Sacituzumab Govitecan, Zimberelimab, and Domvanalimab for Patients with Muscle Invasive Bladder Cancer Ineligible for Cisplatin Chemotherapy

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What is this study about?

This clinical trial is focused on studying treatments for muscle invasive bladder cancer, a type of cancer that affects the bladder and has spread into the muscle layer. The study involves three medications: Sacituzumab govitecan, also known as Trodelvy, Zimberelimab (code name AB122), and Domvanalimab (code name AB154). These medications are given as solutions through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective these medications are when used together before and after surgery in patients who cannot or choose not to receive a common chemotherapy treatment called cisplatin. The study will observe how well the combination of these medications works in eliminating the cancer from the bladder and nearby lymph nodes, as well as their impact on the patient’s survival and the cancer’s return.

Participants in the study will receive the medications over a period of time before undergoing surgery to remove the bladder. The study will also monitor the safety and side effects of the treatment combination. The goal is to understand if this combination can be a beneficial treatment option for patients with muscle invasive bladder cancer who are not suitable for cisplatin-based chemotherapy.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical condition, and ability to comply with study procedures.

A negative pregnancy test is required for female patients of childbearing potential within three days before starting the treatment.

2 initial treatment phase

The treatment involves the administration of three medications: sacituzumab govitecan, zimberelimab, and domvanalimab.

These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The specific dosage and frequency of administration are determined by the study protocol and the healthcare team.

3 surgery preparation

After the initial treatment phase, preparation for surgery, known as cystectomy, is planned according to local guidelines.

The timing of the surgery is based on the response to the initial treatment and the overall health status.

4 surgery

The surgery involves the removal of the bladder and is performed to eliminate any remaining cancerous tissue.

The success of the surgery is evaluated by examining the removed tissue for any residual cancer cells.

5 post-surgery treatment

Following surgery, additional treatment with zimberelimab and domvanalimab may be administered to prevent cancer recurrence.

This phase is tailored to the patient’s response to the initial treatment and surgery outcomes.

6 follow-up and monitoring

Regular follow-up visits are scheduled to monitor the patient’s recovery and check for any signs of cancer recurrence.

During these visits, various tests may be conducted to assess the patient’s health and the effectiveness of the treatment.

Who Can Join the Study?

Willing and able to provide written informed consent.
Have adequate blood clotting ability. This means certain blood tests (Prothrombin Time [PT] or International Normalized Ratio [INR] and Activated Partial Thromboplastin Time [aPTT]) should be no more than 1.5 times the normal limit, unless the person is on blood-thinning medication and the test results are within the intended range for that medication.
Female patients who can have children must have a negative pregnancy test within 3 days before starting the study.
Male and female patients who can have children and engage in heterosexual intercourse must agree to use specific methods of birth control as described in the study details.
Must be able to follow the study procedures, requirements, and restrictions.
Must be 18 years of age or older.
Have a type of bladder cancer called muscle invasive urothelial carcinoma at a specific stage (cT2-T4cN0-1cM0). Patients with other types of bladder cancer, like squamous or adenocarcinoma, can also join.
Must be fit and planned for a surgery called cystectomy according to local guidelines.
Must have refused a type of chemotherapy called neoadjuvant cisplatin-based chemotherapy or be considered not suitable for it. This decision will be made by the study doctor.
Must provide a sample of the tumor tissue, either as a block or at least 15 unstained slides, for testing. If fewer than 15 slides are available, but no less than 10, the patient may still be eligible after discussion with the study leader.
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2, which is a scale used to assess how a patient’s disease is progressing and how the disease affects their daily living abilities.
Have adequate blood and organ function, which means:
- White blood cell count of at least 2.0 x 10⁹ per liter.
- Neutrophil count of at least 1.5 x 10⁹ per liter.
- Platelet count of at least 100 x 10⁹ per liter.
- Hemoglobin level of at least 10 grams per deciliter.
- Creatinine clearance of at least 30 milliliters per minute, which is a measure of kidney function.
- AST (a liver enzyme) level no more than 2.5 times the normal limit.
- ALT (another liver enzyme) level no more than 2.5 times the normal limit.
- Bilirubin level no more than 1.5 times the normal limit.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario De Toledo Ute	Toledo	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Hdiikxam Uoimhegfbitlf Ddcpuhpq	Donostia / San Sebastian	Spain
Hhyhhdlr Ukzjutbgxlfve Mlyoimo Dm Vspytsjqsk	Santander	Spain
Itfpvuzz Crbcpj Dczasgqtqjkehnwvv	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.07.2024

Trial locations

Investigated drugs:

Sacituzumab govitecan is a medication used in this trial to treat muscle invasive bladder cancer. It is an antibody-drug conjugate, which means it combines an antibody with a chemotherapy drug. The antibody part helps the medication find and attach to cancer cells, while the chemotherapy part works to kill those cells. This medication is being tested to see how well it works in patients who cannot or do not want to receive traditional platinum-based chemotherapy.

Zimberelimab is an immunotherapy drug used in this trial. It works by helping the body’s immune system recognize and attack cancer cells. This medication is part of a class of drugs known as checkpoint inhibitors, which block certain proteins that prevent the immune system from attacking cancer cells effectively.

Domvanalimab is another immunotherapy drug included in this study. Similar to zimberelimab, it is designed to enhance the immune system’s ability to fight cancer. It targets specific proteins that can inhibit the immune response, allowing the body to better target and destroy cancer cells. This medication is being tested in combination with the other drugs to see if it improves treatment outcomes for patients with muscle invasive bladder cancer.

Investigated diseases:

Bladder cancer

Bladder Cancer – Bladder cancer is a disease where abnormal cells grow uncontrollably in the bladder, which is the organ responsible for storing urine. It often begins in the cells lining the inside of the bladder and can spread to other parts of the body if not managed. The disease may cause symptoms such as blood in the urine, frequent urination, and pain during urination. As it progresses, the cancer can invade deeper layers of the bladder wall and potentially spread to nearby lymph nodes and other organs. The progression of bladder cancer can vary, with some cases remaining superficial and others becoming more invasive. The disease is more common in older adults and is often linked to smoking and exposure to certain chemicals.

Trial ID:

2023-504420-26-00

Protocol code:

FUP415002 / PRISMA-1

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Sacituzumab Govitecan, Zimberelimab, and Domvanalimab for Patients with Muscle Invasive Bladder Cancer Ineligible for Cisplatin Chemotherapy

What is this study about?

Who Can Join the Study?

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