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Study on Niraparib for Patients with Advanced Urothelial Cancer After Initial Platinum 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 urothelial cancer, a type of cancer that affects the lining of the bladder and other parts of the urinary system. The study is investigating the use of a medication called niraparib, which is taken as a hard capsule. Niraparib is being compared to the best supportive care, which means providing the best possible care without using the study medication, to see if it can help maintain the condition of patients whose cancer has not worsened after initial chemotherapy treatment that included platinum-based drugs.

The purpose of the study is to determine if maintenance treatment with niraparib can effectively prolong the time patients live without their disease getting worse. Participants in the study will be randomly assigned to receive either niraparib or the best supportive care. The study will monitor patients over a period to see how long they remain free from disease progression and to assess their overall survival, quality of life, and any side effects they may experience.

Patients who have completed their first round of chemotherapy and have not seen their cancer progress are eligible to participate. The study will also look at how well patients respond to the treatment and how long these responses last. The trial aims to provide valuable information on whether niraparib can be a beneficial maintenance treatment for patients with advanced urothelial cancer.

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

    Enrollment

    Enrollment occurs within 28 days of a radiological survey showing disease stability or partial/complete response, and no more than 42 days after the last dose of chemotherapy.

    Eligibility requires a diagnosis of non-resectable or metastatic urothelial cancer, measurable disease, and completion of 4 to 6 cycles of platinum-based chemotherapy without disease progression.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either niraparib or best supportive care.

    Niraparib is administered as Zejula 100 mg hard capsules taken orally.

  3. Step 3

    Treatment phase

    Participants receiving niraparib take the medication as directed, with the aim of prolonging the time without disease progression.

    The treatment continues as long as it is effective and tolerated.

  4. Step 4

    Monitoring and assessments

    Regular assessments are conducted to monitor disease status and treatment effects.

    These assessments include measuring progression-free survival and evaluating safety, tolerability, and quality of life.

  5. Step 5

    Completion

    The trial is estimated to end by March 2, 2026.

    Final evaluations will determine the effectiveness of niraparib in maintaining disease control compared to best supportive care alone.

Who can join the trial?

10 criteria

  • You must have a confirmed diagnosis of a type of cancer called urothelial cancer, which cannot be removed by surgery or has spread to other parts of the body.
  • Your cancer must be measurable according to specific guidelines called RECIST before starting the first round of chemotherapy. RECIST is a set of rules used to measure how well a cancer treatment is working.
  • You must have completed a first round of chemotherapy that included a drug containing platinum (such as cisplatin or carboplatin) with at least 4 cycles and no more than 6 cycles.
  • Your cancer must not have gotten worse after finishing the first round of chemotherapy. This means you have either a complete response, partial response, or stable disease according to RECIST guidelines.
  • You need to join the study within 28 days after a scan shows your cancer is stable or has responded to treatment, and no more than 42 days after your last dose of chemotherapy.
  • A blood sample must be available to check for changes in your BRCA genes. These genes are important for repairing DNA.
  • A sample of your tumor tissue must be available to check the status of genes involved in a process called homologous recombination, which is a way cells repair DNA.
  • Your ECOG performance status must be 0-1. This is a scale that measures how well you can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Both men and women can participate in the study.
  • You must be within the age range specified for the study.

Who cannot join the trial?

4 criteria

  • Patients who have not achieved disease control with their first chemotherapy. Disease control means the cancer has not worsened.
  • Patients who have not received a first chemotherapy treatment that includes platinum. Platinum is a type of drug used in cancer treatment.
  • Patients with medical conditions other than urothelial cancer. Urothelial cancer is a type of cancer that affects the bladder and other parts of the urinary system.
  • Patients who are part of a vulnerable population. This means groups of people who might need special protection or care.
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Investigated drugs

Niraparib is a medication used in this clinical trial as a maintenance treatment for patients with locally advanced or metastatic urothelial cancer. It is being tested to see if it can help prolong the time patients live without their disease getting worse after they have responded to initial chemotherapy that includes platinum. Niraparib works by interfering with the cancer cells' ability to repair their DNA, which may help to slow down or stop the growth of the cancer.

What is already known about the treatment

Niraparib – Niraparib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating urothelial cancer, particularly in patients whose disease has not progressed after initial chemotherapy. The main therapeutic indication for Niraparib in this context is as a maintenance treatment to prolong the period during which the cancer does not worsen. At the molecular level, Niraparib works by inhibiting an enzyme called PARP, which helps repair damaged DNA in cells. By blocking this enzyme, Niraparib prevents cancer cells from repairing themselves, leading to their death. It is classified as a PARP inhibitor in pharmacology.

Investigated diseases

Urothelial Cancer – Urothelial cancer is a type of cancer that begins in the urothelial cells lining the bladder, ureters, and part of the kidneys. It is the most common form of bladder cancer and can also occur in other parts of the urinary tract. The disease often starts in the bladder and may spread to nearby tissues or other parts of the body. Symptoms can include blood in the urine, frequent urination, and pain during urination. As the cancer progresses, it may invade deeper layers of the bladder wall and potentially spread to lymph nodes and other organs. Early detection is crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519519-32-00Protocol codeMEET-URO 12Estimated enrolment77 patientsSponsorUniversita' Degli Studi Di Torino

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