Not recruiting

Study of Pembrolizumab and 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 type of cancer called muscle-invasive bladder cancer. This is a condition where cancer cells have spread into the muscle wall of the bladder. The study is exploring the effects of two medications, pembrolizumab and sacituzumab govitecan, on patients who cannot receive or choose not to receive a common chemotherapy treatment known as cisplatin-based chemotherapy. Pembrolizumab, also known by its code name MK-3475, is a medication that helps the immune system fight cancer cells. Sacituzumab govitecan, also referred to as IMMU-132, is a type of treatment that combines an antibody with a drug to target and kill cancer cells.

The purpose of this study is to see if the combination of pembrolizumab and sacituzumab govitecan can lead to a complete response, meaning no signs of cancer are found in the tissue after surgery. Participants in the study will receive these medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will follow a specific schedule where patients will receive the treatment over a period of time, and their health will be monitored closely to observe any changes or side effects. The study aims to understand how well these medications work together and how safe they are for patients.

Throughout the study, researchers will look at how many patients have a complete response to the treatment, as well as monitor any side effects that occur. They will also track how long patients live without the cancer getting worse, known as progression-free survival, and overall survival, which is the length of time patients live after starting the treatment. This information will help determine the effectiveness and safety of using pembrolizumab and sacituzumab govitecan for treating muscle-invasive bladder cancer.

The research process

The trial runs in 7 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 will be conducted to confirm eligibility. This includes a review of medical history and current health status.
A series of tests such as CT, PET/CT, and mpMRI will be performed to assess the stage of muscle-invasive bladder cancer.
Step 2
Consent and preparation
Written informed consent will be obtained after explaining the study details.
For male participants, an agreement to use contraception from the first dose through three months after the last dose is required.
Female participants of childbearing potential must have a negative pregnancy test within 72 hours before the first dose and agree to use two methods of birth control during the study and for six months after the last dose.
Step 3
Treatment initiation
The treatment involves two medications: sacituzumab govitecan and pembrolizumab, both administered as solutions for infusion.
Sacituzumab govitecan is given intravenously. The specific dosage and frequency will be determined by the study team.
Pembrolizumab is also administered intravenously. The dosage and frequency will be specified by the study team.
Step 4
Treatment monitoring
Regular monitoring will occur throughout the treatment period to assess the response and any side effects.
Safety and tolerability will be evaluated, and any adverse events will be recorded and managed according to established criteria.
Step 5
Surgery preparation
Participants will be prepared for radical cystectomy (RC), a surgical procedure to remove the bladder, as part of the treatment plan.
The timing and specific preparations for surgery will be communicated by the medical team.
Step 6
Post-treatment evaluation
After the treatment and surgery, a thorough evaluation will be conducted to determine the presence of any remaining cancer cells.
The primary goal is to achieve a complete pathological response, meaning no viable tumor cells are found.
Step 7
Follow-up
Long-term follow-up will be conducted to monitor overall survival and progression-free survival.
Regular check-ups and tests will be scheduled to ensure ongoing health and to detect any recurrence of cancer.

Who can join the trial?

13 criteria

Must be a female or male over 18 years old and able to understand and sign a consent form.
Men must agree to use a reliable method of birth control from the start of the study until 3 months after the last dose of the study medication.
Must have a specific stage of bladder cancer, known as clinical stage T2-T4aN0M0, confirmed by imaging tests like CT, PET/CT, or MRI.
Must agree to undergo a surgery called RC (removal of the bladder).
Must be unable to receive or choose not to receive a type of chemotherapy called cisplatin-based chemotherapy.
Must have a confirmed diagnosis of a type of bladder cancer called urothelial carcinoma. If the cancer has mixed types, at least 50% must be urothelial carcinoma.
Must be in good enough health to undergo the bladder removal surgery, according to local health guidelines.
Must have an ECOG performance status score of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
Must have adequate blood counts without needing recent blood transfusions or medications to boost blood cell production. This includes hemoglobin levels of at least 9 g/dL, a type of white blood cell count (ANC) of at least 1,500/mm³, and platelet count of at least 100,000/μL.
Must have adequate liver function, with bilirubin levels at or below 1.5 times the upper limit of normal, and AST and ALT levels at or below 2.5 times the upper limit of normal (or 5 times if there are known liver metastases), and serum albumin levels above 3 g/dL.
Must have a creatinine clearance of at least 30 mL/min, which is a measure of kidney function.
Women who can have children must have a negative pregnancy test within 72 hours before starting the study medication and must not be breastfeeding. If the urine test is positive or unclear, a blood test will be required.
Women who can have children must agree to use two methods of birth control, be surgically sterile, or abstain from heterosexual activity during the study and for 6 months after the last dose of study medication. Women who can have children are those who have not had surgery to prevent pregnancy or have not stopped having periods for more than 2 years.

Who cannot join the trial?

10 criteria

Patients who have received any other cancer treatment within the last 4 weeks.
Patients with a history of severe allergic reactions to the study drugs.
Patients with uncontrolled infections.
Patients with other active cancers.
Patients who are pregnant or breastfeeding.
Patients with significant heart problems.
Patients with severe liver or kidney disease.
Patients with a history of autoimmune diseases, which are conditions where the immune system attacks the body.
Patients who have received a live vaccine within 30 days before the start of the study.
Patients with a history of drug or alcohol abuse.

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Verified sites

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

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Investigated drugs

Pembrolizumab
is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. In this trial, pembrolizumab is used to help your body recognize and attack the bladder cancer cells more effectively.
Sacituzumab govitecan
is a targeted therapy that combines an antibody with a chemotherapy drug. The antibody part of the medication helps deliver the chemotherapy directly to the cancer cells, which can help reduce the growth of the tumor. In this trial, sacituzumab govitecan is used alongside pembrolizumab to enhance the treatment's effectiveness against bladder cancer.

What is already known about the treatment

Pembrolizumab
Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently used in medicine to treat various types of cancer, including muscle-invasive bladder cancer, and is well-documented in medical literature. The main therapeutic indication for pembrolizumab in this trial is for patients with muscle-invasive bladder cancer who cannot or choose not to receive cisplatin-based chemotherapy. At the molecular level, pembrolizumab works by blocking a specific protein on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.
Sacituzumab govitecan
Sacituzumab govitecan is administered as an intravenous infusion, allowing the medication to enter the bloodstream directly. It is currently being studied for its effectiveness in treating muscle-invasive bladder cancer, particularly in patients who cannot or refuse to undergo cisplatin-based chemotherapy. The main therapeutic indication for sacituzumab govitecan in this trial is to help achieve a complete response in the cancerous tissue. At the molecular level, sacituzumab govitecan is an antibody-drug conjugate, which means it combines an antibody that targets cancer cells with a chemotherapy drug, delivering the drug directly to the cancer cells to kill them. It is classified as an antibody-drug conjugate, a type of targeted cancer therapy.

Investigated diseases

Muscle-invasive bladder cancer – Muscle-invasive bladder cancer is a type of bladder cancer that has spread into the muscle layer of the bladder wall. It typically begins in the cells lining the bladder and progresses deeper into the bladder tissue. As the cancer grows, it can invade surrounding tissues and organs, potentially spreading to lymph nodes and other parts of the body. The disease often presents with symptoms such as blood in the urine, frequent urination, and pain during urination. Over time, the cancer may cause more severe symptoms and complications as it advances. The progression of muscle-invasive bladder cancer can vary, with some cases advancing more rapidly than others.