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Study on Pre-Operative Nivolumab and Relatlimab for Adults with Stage II-IIIa Muscle-Invasive 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 treatments for muscle-invasive urothelial cancer of the bladder, specifically in adult patients who have not yet received systemic therapy. The study involves two medications: nivolumab and relatlimab. Nivolumab is a medication that is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein. Relatlimab is also given intravenously, meaning it is injected into a vein. The purpose of the study is to evaluate the effectiveness of using nivolumab alone or in combination with relatlimab as a treatment before surgery for this type of bladder cancer.

Participants in the study will receive either nivolumab alone or a combination of nivolumab and relatlimab before undergoing surgery to remove the cancer. The study aims to determine how well these treatments work in reducing the cancer before surgery. The trial will monitor the participants' response to the treatment and any side effects they may experience. The study will also look at how many participants are able to complete the surgery within a specific timeframe and track their overall survival and any recurrence of the cancer.

The trial is expected to run for several years, with the goal of gathering enough information to understand the potential benefits and risks of these treatments for patients with muscle-invasive urothelial cancer. By participating in this study, researchers hope to find more effective ways to treat this type of cancer and improve outcomes for patients in the future.

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 trial
Upon joining the trial, the patient will provide informed consent, confirming understanding and willingness to participate.
A negative pregnancy test is required for female patients of childbearing potential within two weeks before starting the treatment.
Step 2
Pre-treatment preparation
The patient will undergo a consultation with a urologist to discuss and accept surgical resection (cystectomy) as the advised treatment.
Female patients must use highly effective contraception if there is a risk of conception.
Step 3
Treatment administration
The patient will receive **nivolumab** and possibly **relatlimab** as part of the treatment. Both medications are administered intravenously, meaning they are given through a vein.
The specific dosage, frequency, and duration of administration will be explained by the healthcare team.
Step 4
Monitoring and follow-up
The patient's health and response to the treatment will be closely monitored throughout the trial.
Regular check-ups and tests will be conducted to assess the effectiveness of the treatment and to identify any side effects.
Step 5
Surgery
The patient will undergo a cystectomy, which is the surgical removal of the bladder, as part of the treatment plan.
The goal is to complete the surgery within 12 weeks from the start of the treatment.
Step 6
Post-surgery evaluation
After the surgery, the patient will be evaluated for a pathological complete response, which means no remaining cancer cells are found in the tissue removed during surgery.
Further follow-up will be conducted to monitor overall survival and any recurrence of the disease.

Who can join the trial?

17 criteria

Willing and able to provide informed consent.
Negative pregnancy test within 2 weeks of starting the study for female patients who can have children.
Surgical removal of the bladder (cystectomy) is recommended and accepted by the patient after talking with a urologist.
Use of highly effective birth control for female patients if there is a risk of becoming pregnant. Female patients who can have children must follow the birth control methods required by the study.
Age must be 18 years or older.
Have a type of bladder cancer called resectable muscle-invasive urothelial cancer, which means the cancer can be surgically removed. This is defined as certain stages of cancer (cT2-4aN0M0 OR cT1-4aN1M0). For cT1N1 patients, lymph node involvement must be confirmed by tests.
Patients are either not able to take a chemotherapy drug called cisplatin or choose not to take it after discussing the risks and benefits with their doctor. Eligibility for cisplatin is based on specific criteria.
Have a World Health Organization (WHO) performance status of 0 or 1, which means the patient is fully active or has some symptoms but can carry out light work.
The main type of cancer must be urothelial cancer (more than 50%). Any presence of small cell or adenocarcinoma types is not allowed.
Availability of tumor samples preserved in a specific way (formalin-fixed paraffin-embedded) from a previous diagnostic procedure.
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Screening blood tests must meet certain criteria:
- White blood cells (WBC) ≥ 2.0x10⁹/L
- Neutrophils ≥ 1.0x10⁹/L
- Platelets ≥ 100 x10⁹/L
- Hemoglobin ≥ 5.5 mmol/L
- Glomerular filtration rate (GFR) > 30 ml/min, which measures kidney function
- AST and ALT (liver enzymes) ≤ 1.5 times the upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times the ULN

Who cannot join the trial?

4 criteria

Patients who have already received **systemic therapy** for bladder cancer. Systemic therapy refers to treatment that affects the entire body, such as chemotherapy.
Patients with bladder cancer that is not classified as **stage II or IIIa**. These stages refer to specific sizes and spread of the cancer within the bladder.
Patients with any other type of cancer that is not muscle-invasive urothelial cancer of the bladder.
Patients who are part of a **vulnerable population**. This term generally refers to groups who may have limited ability to give informed consent or are at higher risk of being harmed by the study.

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Verified sites

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Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands
Responsive
Stichting Radboud University Medical Center
Nijmegen, The Netherlands

Trial locations

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Investigated drugs

Nivolumab
is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, nivolumab is being used before surgery to see if it can help shrink the bladder cancer tumors and make them easier to remove.
Relatlimab
is another immune checkpoint inhibitor that works in a similar way to nivolumab. It helps your immune system target and destroy cancer cells. In this study, relatlimab is being tested in combination with nivolumab to see if the two medications together can improve the treatment outcomes for bladder cancer patients before they undergo surgery.

What is already known about the treatment

Nivolumab
Nivolumab 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 certain types of bladder cancer, specifically in patients with muscle-invasive urothelial cancer who have not yet received systemic therapy. Nivolumab works by blocking a protein called PD-1 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.
Relatlimab
Relatlimab is also given as an intravenous infusion, similar to nivolumab. It is being investigated in combination with nivolumab for its potential to enhance treatment outcomes in bladder cancer patients. Relatlimab targets a protein called LAG-3 on immune cells, which can suppress the immune response against cancer. By inhibiting LAG-3, relatlimab may boost the immune system's ability to combat cancer cells. It is part of the same pharmacological class as nivolumab, known as immune checkpoint inhibitors, which are designed to strengthen the immune response against cancer.

Investigated diseases

Muscle-Invasive Urothelial Carcinoma of the Bladder – This disease is a type of bladder cancer that begins in the urothelial cells lining the bladder. It is characterized by the cancer invading the muscle layer of the bladder wall. As the disease progresses, it can spread to nearby tissues and organs. In advanced stages, it may metastasize to distant parts of the body, such as the lymph nodes, bones, or lungs. The progression of the disease can lead to symptoms such as blood in the urine, frequent urination, and pelvic pain. Early detection and management are crucial to control the spread and impact of the disease.