Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of Eciskafusp Alfa and BCG for Patients with High-Risk Bladder Cancer Not Responding to BCG Treatment

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 type of bladder cancer known as high-risk non-muscle invasive bladder cancer that does not respond to a common treatment called Bacillus Calmette-Guérin (BCG). The study will explore a new treatment combination involving a medication called eciskafusp alfa and BCG. Eciskafusp alfa is being tested to see if it can help patients whose cancer has not been controlled by BCG alone.

The purpose of the study is to evaluate the safety and effectiveness of this new treatment combination. Participants will receive the treatment directly into the bladder, a method known as intravesical use. The study will be conducted in two phases. The first phase will focus on determining the safest dose of eciskafusp alfa when used with BCG. The second phase will assess how well the treatment works in preventing the cancer from returning or getting worse.

Throughout the study, participants will be monitored for any side effects and the overall response of their cancer to the treatment. The study aims to find out if this new combination can provide a better outcome for patients with this type of bladder cancer. Participants will undergo regular check-ups, including procedures like cystoscopy, which is a way to look inside the bladder, and imaging tests to track the progress of the treatment.

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

    Initial treatment phase

    The study begins with the administration of two medications: eciskafusp alfa and bacillus Calmette-Guérin (BCG). These are given through a procedure called intravesical use, which means they are delivered directly into the bladder.

    The purpose of this phase is to evaluate the safety and tolerability of the combination of these medications. The dosage may be adjusted to determine the most effective and safe amount.

  2. Step 2

    Dose escalation

    During this phase, the dosage of eciskafusp alfa may be gradually increased. This is done to find the maximum dose that can be tolerated without causing severe side effects.

    The goal is to identify the recommended dose for further treatment.

  3. Step 3

    Monitoring and evaluation

    Regular monitoring is conducted to assess the response to the treatment. This includes checking for the absence of high-risk bladder cancer through procedures like cystoscopy and imaging tests.

    The presence of any adverse effects is also closely monitored and recorded.

  4. Step 4

    Extension phase

    If the initial phases show positive results, the study may continue with an extension phase. This involves using the recommended dose identified earlier to further evaluate its effectiveness.

    The focus is on the anti-tumor activity and the duration of the response to the treatment.

  5. Step 5

    Long-term follow-up

    Participants will be followed over a longer period to monitor the complete response rate at various intervals, such as 6, 12, 18, and 24 months.

    The study will also track the progression-free survival, which means the time during which the cancer does not worsen or spread.

Who can join the trial?

11 criteria

  • The patient must have a confirmed diagnosis of **high-risk non-muscle invasive bladder cancer**. This type of cancer is found in the bladder but has not spread to the muscle layer.
  • The patient must have **carcinoma in situ (CIS)**, which is a type of cancer that is flat and stays on the surface of the bladder. It can be with or without other types of early-stage bladder cancer (Ta/T1).
  • If the patient has tumors with different types of cancer cells, the main type must be **transitional cell carcinoma**, which is the most common type of bladder cancer.
  • The patient must have CIS present in the tumor sample from the most recent **transurethral resection of bladder tumor (TURBT)**, a procedure to remove bladder tumors.
  • The patient must have an **Eastern Cooperative Oncology Group (ECOG) performance status** of 0 or 1 for Phase I, and 0, 1, or 2 for Phase II. This is a scale that measures how well the patient can perform daily activities.
  • The patient must not have any disease that can be surgically removed after TURBT procedures. If there is still CIS, it is acceptable. Patients with T1 tumors must have another resection and biopsy if the first one did not include a specific muscle layer called **muscularis propria**.
  • The patient must have **BCG-unresponsive disease**, meaning the cancer did not respond to or came back after treatment with **Bacillus Calmette-Guérin (BCG)**, a common bladder cancer treatment. This must happen within 12 months of receiving enough BCG therapy.
  • The patient must be considered ineligible for **radical cystectomy**, a surgery to remove the bladder, or have chosen not to have this surgery. The reasons for this decision should be discussed and recorded.
  • The patient must be within the age range of adults and older adults.
  • Both male and female patients can participate.
  • The study may include vulnerable populations, which are groups that might need special protection or consideration.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of bladder cancer that is not **BCG-Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC)**.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to safely receive the study treatment due to other health conditions.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies or reactions to the study drugs or similar treatments.
  • Patients who have a history of other cancers that might interfere with the study results.
  • Patients who are unable to follow the study procedures or attend the required visits.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Eciskafusp Alfa

    is an experimental medication being tested in this clinical trial. It is being studied to see if it can help treat high-risk non-muscle invasive bladder cancer that has not responded to other treatments. The trial aims to find out how safe and tolerable this medication is when used with another treatment, and to determine the best dose to use in future studies.

  • Bacillus Calmette-Guérin (BCG)

    is a type of immunotherapy used to treat bladder cancer. It is made from a weakened form of bacteria that helps stimulate the immune system to attack cancer cells in the bladder. In this trial, BCG is used in combination with eciskafusp alfa to see if the two treatments together can be more effective in treating bladder cancer.

What is already known about the treatment

Eciskafusp Alfa – This medication is administered intravesically, meaning it is delivered directly into the bladder. It is currently being studied in clinical trials for its potential use in treating BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC). The main therapeutic indication is to evaluate its safety, tolerability, and anti-tumor activity when used in combination with Bacillus Calmette-Guérin (BCG). At the molecular level, eciskafusp alfa is designed to enhance the immune response against cancer cells. It is classified pharmacologically as an immunotherapy agent.

Investigated diseases

BCG-Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) – This type of bladder cancer occurs when cancer cells form in the tissues of the bladder but have not spread into the muscle layer. It is considered high-risk due to its potential to recur or progress despite treatment. The term "BCG-unresponsive" indicates that the cancer does not respond to Bacillus Calmette-Guérin (BCG) therapy, a common treatment for bladder cancer. Patients with this condition may experience frequent urination, blood in the urine, and discomfort. The disease is monitored through cystoscopy and imaging to assess any changes in the bladder tissue. Regular follow-ups are essential to manage and observe the progression of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-515410-41-00Protocol codeBP45381Estimated enrolment23 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.