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Study on Cisplatin, Nab-paclitaxel, and Nivolumab with Radiotherapy for Patients with Non-Metastatic Muscle Invasive Bladder Cancer

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 the treatment of non-metastatic muscle-invasive bladder cancer. The study involves a combination of medications and therapies, including Nivolumab, Cisplatin, and Paclitaxel Albumin-Bound, along with radiotherapy. These treatments are administered after the surgical removal of the tumor to see if they can improve the time patients remain free from the disease.

The purpose of the study is to investigate how effective this combination of treatments is in preventing the return of cancer in patients with this type of bladder cancer. Participants will receive these medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will also include radiotherapy, a treatment that uses high-energy rays to target and kill cancer cells. The trial will monitor patients over a period to assess their response to the treatment and any side effects they may experience.

Throughout the study, researchers will collect data to understand the safety and effectiveness of the treatment combination. They will look at how many patients remain free of cancer, how many might need additional surgery, and the overall quality of life of the participants. The study aims to provide valuable information that could help improve treatment options for patients with muscle-invasive bladder cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be required to provide written consent to participate.

    You must meet specific criteria, such as being 18 years or older, having a diagnosis of non-metastatic muscle invasive bladder cancer, and having adequate organ function as determined by laboratory tests.

  2. Step 2

    Initial assessments

    Before starting treatment, you will undergo various assessments, including imaging tests like CT or MRI, and possibly a PET scan, to confirm the absence of metastatic disease.

    A trans-urethral resection of the bladder tumor (TURBT) should have been attempted within 56 days prior to starting treatment, unless a recent cystoscopy shows no residual disease.

  3. Step 3

    Treatment phase

    The treatment involves a combination of medications and radiotherapy. You will receive cisplatin, paclitaxel albumin-bound, and nivolumab through intravenous administration.

    The specific dosage and frequency of these medications will be determined by the medical team based on your individual condition and response to treatment.

    Concomitant radiotherapy will be administered alongside the medication regimen to enhance treatment efficacy.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, your health and response to treatment will be closely monitored through regular medical check-ups and tests.

    You will be evaluated for any side effects or complications from the treatment, and adjustments may be made to your treatment plan as necessary.

  5. Step 5

    End of treatment

    After completing the treatment phase, you will continue to be monitored for disease-free survival, which is the primary goal of the study.

    Follow-up visits will be scheduled to assess your health status and any long-term effects of the treatment.

Who can join the trial?

12 criteria

  • Must be 18 years old or older.
  • Must be able and willing to give written informed consent, which means you agree to participate after understanding the study.
  • For women who can have children, you must use a very effective birth control method during the study and for at least 5 months after the last treatment. Men must use birth control for 6 months after the last treatment if they are sexually active with women who can have children.
  • Must have adequate bone marrow, liver, and kidney function. This will be checked with blood tests to ensure your body can handle the treatment.
  • Must have a diagnosis of bladder cancer that is mostly made up of a type called urothelial carcinoma. Other types are allowed except for small cell cancer.
  • Cancer must be at Stage T2-T3 N0M0, which means it has not spread to lymph nodes or other parts of the body. This will be checked with imaging tests like CT or MRI.
  • Must have a FDG-PET scan within 6 weeks before starting treatment, showing no spread of cancer to lymph nodes or other areas.
  • Must have had an attempt to completely remove the bladder tumor within 8 weeks before starting treatment. If this was done more than 8 weeks ago, a recent check must show no remaining cancer.
  • Must have a life expectancy of more than 6 months.
  • Must have an ECOG performance status of 1 or better, which means you are fully active or have some symptoms but can still do light work.
  • Can have another type of cancer only if it was treated successfully at least 3 years ago with no return, or if it is a slow-growing type like low-risk prostate cancer.
  • Must be considered able to tolerate the treatment by both the radiation and medical doctors involved in the study.

Who cannot join the trial?

5 criteria

  • Patients with metastatic muscle invasive bladder cancer cannot participate. Metastatic means that the cancer has spread to other parts of the body.
  • Patients who have not had maximal tumor resection are excluded. Maximal tumor resection means that as much of the tumor as possible has been surgically removed.
  • Patients who cannot receive cisplatin, nab-paclitaxel, or nivolumab are not eligible. These are specific types of cancer treatments.
  • Patients who cannot undergo radiotherapy are excluded. Radiotherapy is a treatment that uses high doses of radiation to kill cancer cells.
  • Patients who are part of a vulnerable population are not eligible. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

  • Cisplatin

    is a type of chemotherapy medication used to treat various types of cancer, including bladder cancer. It works by damaging the DNA in cancer cells, which prevents them from growing and dividing. In this trial, it is used to help kill any remaining cancer cells after surgery.

  • Nab-paclitaxel

    is another chemotherapy drug that is used to treat cancer. It is a form of paclitaxel that is bound to a protein called albumin, which helps it to be absorbed by the body more effectively. This medication works by stopping cancer cells from dividing, which can slow or stop the growth of the tumor.

  • Nivolumab

    is an immunotherapy drug that helps the body's immune system fight cancer. It works by blocking a protein called PD-1, which can prevent the immune system from attacking cancer cells. By blocking this protein, nivolumab helps the immune system recognize and destroy cancer cells more effectively.

What is already known about the treatment

  • Cisplatin

    Cisplatin is administered intravenously, meaning it is given through a vein, usually in a hospital or clinic setting. It is a well-established chemotherapy drug used in the treatment of various cancers, including bladder cancer. Its main therapeutic indication in this trial is for patients with non-metastatic muscle invasive bladder cancer. At the molecular level, cisplatin works by binding to DNA in cancer cells, causing damage that prevents the cells from dividing and growing. It is classified as a platinum-based chemotherapy agent.

  • Nab-paclitaxel

    Nab-paclitaxel is given as an intravenous infusion, typically in a medical facility. It is a form of chemotherapy used to treat different types of cancer, including bladder cancer. In this trial, it is used for patients with non-metastatic muscle invasive bladder cancer. Nab-paclitaxel works by interfering with the normal function of microtubules, which are structures that help cells divide, thus stopping cancer cell growth. It is classified as a taxane chemotherapy drug.

  • Nivolumab

    Nivolumab is administered as an intravenous infusion, usually in a healthcare setting. It is an immunotherapy drug that has been approved for use in various cancers, including bladder cancer. In this trial, it is used for patients with non-metastatic muscle invasive bladder cancer. Nivolumab works by blocking a protein called PD-1 on immune cells, which enhances the body's immune response against cancer cells. It is classified as a PD-1 inhibitor, a type of immune checkpoint inhibitor.

Investigated diseases

Muscle Invasive Bladder Cancer – Muscle invasive bladder cancer is a type of bladder cancer where the cancer cells have grown into the muscle layer of the bladder wall. This disease typically begins in the cells lining the bladder and progresses as these cells invade deeper layers of the bladder wall. As the cancer advances, it can spread to nearby tissues and organs, including the lymph nodes and other parts of the body. The progression of muscle invasive bladder cancer can lead to symptoms such as blood in the urine, frequent urination, and pain during urination. Over time, the disease may cause more severe symptoms as it affects other body systems. The progression of the disease is influenced by various factors, including the cancer's stage and grade at diagnosis.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518937-26-00Protocol codeCA209-6E8, CNN-BCEstimated enrolment24 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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