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Study of Visugromab and Nivolumab for Patients with Muscle-Invasive Bladder Cancer Who Cannot or Refuse Cisplatin Chemotherapy

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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 treatment of muscle-invasive bladder cancer, a type of cancer that affects the bladder and requires significant medical intervention. The study involves a new treatment approach using a combination of medications. One of the medications being tested is called visugromab (CTL-002), which is an antibody designed to target a specific protein involved in cancer growth. This medication will be used alongside another type of drug known as an anti-PD-1 checkpoint inhibitor, which helps the immune system recognize and attack cancer cells. The well-known drug nivolumab is an example of an anti-PD-1 checkpoint inhibitor that may be used in this study. Additionally, some participants may receive a placebo as part of the trial.

The purpose of this study is to evaluate the effectiveness of the combination of visugromab and an anti-PD-1 checkpoint inhibitor compared to the anti-PD-1 checkpoint inhibitor alone. Participants in the study will receive these treatments through an intravenous infusion, which means the medication is delivered directly into the bloodstream. The study will last for a period of up to 12 months, during which participants will be closely monitored by healthcare professionals. The study aims to assess how well the treatment works in reducing the size of the tumor and improving the overall health of the participants.

Throughout the study, participants will undergo various assessments, including imaging tests like computed tomography (CT) and magnetic resonance imaging (MRI), to evaluate the response of the cancer to the treatment. The study will also monitor for any side effects or adverse reactions to the medications. The ultimate goal is to determine if this new combination of treatments can provide a more effective option for patients with muscle-invasive bladder cancer who are unable or unwilling to receive traditional chemotherapy treatments.

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
Initial treatment phase
The study involves the administration of two main medications: visugromab (CTL-002) and nivolumab. These are given as a combination therapy to assess their effectiveness in treating muscle-invasive bladder cancer.
Both medications are administered as a solution for infusion, which means they are given directly into the bloodstream through a vein (intravenous).
Step 2
Medication administration
The medication OPDIVO (nivolumab) is provided as a 10 mg/mL concentrate for solution for infusion. It is administered intravenously.
The infusion process involves the use of sodium chloride as a solution to help deliver the medication into the body.
Step 3
Treatment duration
The treatment is planned to last for a minimum of 12 weeks before any scheduled surgery, such as radical cystectomy, which is a procedure to remove the bladder.
Step 4
Monitoring and evaluation
Throughout the study, the response to the treatment is monitored using various methods, including imaging techniques like CT scans, PET/CT, or MRI.
The primary goal is to evaluate the pathologic complete response and the radiologic response to the combination therapy.
Step 5
Safety and side effects
The study also focuses on assessing any adverse effects that may occur during the treatment. This includes monitoring for serious adverse events and any abnormal clinical findings.
Participants are evaluated for any treatment-related delays in surgery and the development of anti-drug antibodies.
Step 6
End of study
The study is expected to conclude by January 2027, with ongoing assessments of the treatment's effectiveness and safety throughout the duration.

Who can join the trial?

15 criteria

Must understand the purpose of the study and agree to participate by signing a consent form.
If you have Type II diabetes and take metformin, you need to switch to another diabetes medication at least 7 days before starting the study treatment.
Women who can have children must have a negative pregnancy test within 7 days before starting the study treatment.
All participants, and their partners who can have children, must agree to use highly effective methods of contraception during the study and for at least 5 months after the last dose of the study drug. This includes certain hormonal methods, devices placed in the uterus, or surgical procedures.
Must be 18 years or older.
Must have a confirmed diagnosis of urothelial carcinoma, a type of bladder cancer. If there are mixed types of cancer cells, at least 50% must be transitional cell type.
Must have a specific stage of bladder cancer (T2-T4aN0M0) as determined by a CT scan, with optional PET/CT or MRI scans.
Must be unable to receive cisplatin therapy due to certain health conditions or choose not to receive it. This includes hearing loss, nerve damage, reduced kidney function, or certain heart conditions.
Must be eligible for radical cystectomy (RC), a surgery to remove the bladder, and able to receive at least 12 weeks of treatment before the surgery.
Must have tumor material available from a previous procedure (TURBT) for scientific analysis, taken within 3 months before starting the study treatment.
Must have an ECOG performance status score of 0 or 1, indicating good physical health.
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Must have adequate organ function, including:
- Bone marrow: sufficient levels of hemoglobin, platelets, and white blood cells.
- Liver: normal levels of liver enzymes and bilirubin.
- Kidneys: normal creatinine levels or sufficient kidney function.
- Blood clotting: no significant issues with blood clotting or thrombosis.

Who cannot join the trial?

5 criteria

Patients who have a different type of cancer other than muscle-invasive bladder cancer.
Patients who are not planning to have a radical cystectomy, which is a surgery to remove the bladder.
Patients who can receive or choose to receive cisplatin-based chemotherapy, a type of cancer treatment using drugs.
Patients who are not eligible for the age range specified for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

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Verified sites

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

Responsive
Azienda Ospedaliera Ordine Mauriziano Di Torino
Turin, Italy
Verified
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Turin, Italy
Responsive
Istituto Oncologico Veneto
Padua, Italy

Trial locations

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Investigated drugs

Visugromab (CTL-002)
is an experimental medication being studied for its potential to treat muscle-invasive bladder cancer. It is an antibody that targets a specific protein called GDF-15, which may play a role in cancer growth. In this trial, visugromab is used in combination with another type of medication to see if it can help shrink tumors before surgery.
Anti-PD-1 Checkpoint Inhibitor
is a type of immunotherapy that helps the immune system recognize and attack cancer cells. It works by blocking a protein called PD-1, which can prevent the immune system from effectively fighting cancer. In this study, the anti-PD-1 checkpoint inhibitor is used alone and in combination with visugromab to evaluate its effectiveness in treating muscle-invasive bladder cancer.

What is already known about the treatment

Visugromab (CTL-002) – This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating muscle-invasive bladder cancer. It is an investigational drug, not yet approved for general medical use, and is being evaluated for its effectiveness when combined with an anti-PD-1 checkpoint inhibitor. The main therapeutic indication is for patients with muscle-invasive bladder cancer who are unable or unwilling to receive cisplatin-based chemotherapy. Visugromab works by targeting and inhibiting the activity of GDF-15, a protein that can suppress the immune system's ability to fight cancer. It is classified as an immunotherapy agent, specifically an anti-GDF-15 antibody.

Investigated diseases

Muscle-Invasive Bladder Cancer – This type of bladder cancer occurs when cancer cells grow into the muscle layer of the bladder wall. It is more aggressive than non-muscle-invasive bladder cancer and has a higher risk of spreading to other parts of the body. The disease often begins with symptoms such as blood in the urine, frequent urination, or pain during urination. As it progresses, it may cause more severe symptoms, including pelvic pain and weight loss. The cancer can spread to nearby tissues and organs, making it more challenging to manage. Early detection and monitoring are crucial to managing the disease effectively.