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Study of ONCOFID-P-B for Patients with Bladder Carcinoma in Situ Unresponsive to BCG Treatment

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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 condition known as Carcinoma in Situ of the bladder, which is a type of bladder cancer that has not responded to the standard treatment called BCG therapy. The study is investigating a new treatment called ONCOFID-P-B, which is a special formulation of a drug named paclitaxel obaluronate. This treatment is administered directly into the bladder, a method known as intravesical administration. The main goal of the study is to evaluate how effective and safe this new treatment is for patients who have not had success with previous therapies.

Participants in the study will receive the ONCOFID-P-B treatment over a period of time, and their response to the treatment will be closely monitored. The study will look at how many patients achieve a complete response, meaning no signs of cancer are detected, at various points during the study. The study will also track how long the response lasts, whether the cancer progresses, and the overall survival of the participants. Some patients may receive a placebo, which is a substance with no active drug, to compare the effects of the new treatment.

The study is designed to provide valuable information about the potential benefits of ONCOFID-P-B for patients with Carcinoma in Situ of the bladder who have not responded to BCG therapy. By participating in this study, researchers hope to find a new and effective treatment option for this challenging condition. The study is expected to continue until 2030, allowing for comprehensive data collection and analysis.

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, the patient must provide written informed consent. This is a document that confirms understanding and agreement to participate in the study.

    The patient must be at least 18 years old and have a confirmed diagnosis of BCG-unresponsive Carcinoma in Situ of the bladder, with or without Ta-T1 papillary disease.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm the patient's eligibility. This includes a review of medical history and a physical examination.

    The patient must have adequate organ function and a performance status that allows participation in the study.

  3. Step 3

    Treatment administration

    The patient will receive ONCOFID-P-B, which is a solution administered directly into the bladder. This is known as intravesical administration.

    The treatment involves a conjugate of paclitaxel and hyaluronic acid, designed to target bladder cancer cells.

  4. Step 4

    Monitoring and follow-up

    The patient's response to the treatment will be monitored regularly. This includes checking for any side effects and assessing the effectiveness of the treatment.

    Follow-up visits will be scheduled to evaluate the patient's condition and adjust the treatment plan if necessary.

  5. Step 5

    Completion of study

    The study is expected to continue until May 31, 2030. The patient's participation may end earlier if the treatment is completed or if there are any medical reasons to stop.

    Upon completion, the patient's overall response to the treatment will be assessed, and further medical advice will be provided.

Who can join the trial?

10 criteria

  • Willing and able to provide written consent to participate in the study.
  • Able and willing to attend scheduled visits, follow therapy plans, and undergo necessary tests.
  • Must be 18 years or older, regardless of gender.
  • Have a confirmed diagnosis of persistent or returning Carcinoma in Situ (CIS) of the bladder, with or without additional papillary disease, and no signs of cancer spread as shown by a CT or MRI scan.
  • Patients who did not respond to BCG therapy and either refuse or are not suitable for bladder removal surgery. BCG-unresponsive means the disease persists or returns within 12 months after completing adequate BCG treatment, which involves specific doses of BCG therapy.
  • Complete removal of papillary lesions before joining the trial, if present alongside CIS. Some remaining CIS is acceptable, but obvious areas should be treated.
  • Have an ECOG performance status of 0, 1, or 2, which measures the ability to perform daily activities.
  • Have adequate organ function, including specific levels of blood cells, liver enzymes, and kidney function.
  • Women who are not able to have children or are postmenopausal. Women who can have children must have a negative pregnancy test and agree to use highly effective birth control methods.
  • Male patients with partners who can have children must agree to use effective birth control methods, such as condoms.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of bladder cancer that is not BCG-unresponsive Carcinoma in Situ. This means the cancer does not respond to a specific treatment called BCG.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who are pregnant or breastfeeding, as the study may not be safe for them or their baby.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had another type of cancer in the past, unless it was treated and has not come back for a certain period.
  • Patients who have an infection or other medical condition that could affect their safety during the study.
  • Patients who have a history of allergic reactions to the study medication or similar drugs.
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Investigated drugs

ONCOFID-P-B is a medication being studied for its potential to treat bladder cancer. It is a combination of paclitaxel, a drug that helps stop cancer cells from growing, and hyaluronic acid, which helps the medication stay in the bladder longer. This combination is administered directly into the bladder to target cancer cells more effectively. The study aims to see how well this treatment works in patients whose bladder cancer has not responded to previous treatments.

What is already known about the treatment

ONCOFID-P-B – This medication is administered directly into the bladder, known as intravesical administration. It is currently being studied in clinical trials for its effectiveness and safety in treating bladder cancer that does not respond to BCG therapy. The main therapeutic indication is for carcinoma in situ of the bladder, with or without additional papillary disease. ONCOFID-P-B works by combining paclitaxel, a chemotherapy drug, with hyaluronic acid to enhance its delivery and retention in the bladder, thereby increasing its antitumor activity. It is classified pharmacologically as an antineoplastic agent.

Investigated diseases

BCG-unresponsive Carcinoma in Situ of the bladder – This is a type of bladder cancer that does not respond to Bacillus Calmette-Guérin (BCG) therapy, which is a common treatment for bladder cancer. It is characterized by the presence of cancerous cells in the lining of the bladder that have not invaded deeper layers. The disease may occur with or without Ta-T1 papillary tumors, which are non-muscle invasive bladder cancers. Over time, if untreated or unresponsive to treatment, the carcinoma in situ can progress to more invasive forms of bladder cancer. The progression involves the potential spread of cancer cells to deeper layers of the bladder or other parts of the body. Monitoring and assessment are crucial to manage the disease and prevent further progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512568-72-00Protocol codeR39_21_01Estimated enrolment149 patientsSponsorFidia Farmaceutici S.p.A.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).