Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of nadofaragene firadenovec alone or with gemcitabine, docetaxel or pembrolizumab in adults with non-muscle invasive bladder cancer who did not respond to BCG therapy

Fast replyRegistered drug
Clinical Trials Concierge

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

Featured sites

Sites that work closely with us on this trial

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with non-muscle invasive bladder cancer who have not responded to previous treatment with Bacillus Calmette-Guerin therapy. The study will evaluate a new treatment approach using nadofaragene firadenovec, either alone or in combination with other medications. The combinations will include chemotherapy drugs (gemcitabine and docetaxel) or immunotherapy (pembrolizumab).

The purpose of this research is to determine how safe and effective these treatment combinations are for patients whose bladder cancer has not responded to standard therapy. The treatment involves placing medication directly into the bladder through a process called intravesical instillation. The study will monitor how well the cancer responds to these treatments over time.

During the study, which may last up to 24 months, participants will receive their assigned treatment according to a specific schedule. Some patients will receive only nadofaragene firadenovec, while others will receive it in combination with either chemotherapy or immunotherapy. The study will track whether the cancer disappears completely after treatment, which is called a complete response.

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 assessment

    Your medical condition has been identified as non-muscle invasive bladder cancer that has not responded to previous BCG therapy

    Laboratory tests will be performed to check blood counts, liver function, and kidney function to ensure eligibility for treatment

    Imaging tests (CT scan or MRI) will be performed to confirm the absence of cancer in the upper urinary tract

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of three treatment groups:

    Group 1: Nadofaragene firadenovec alone (administered directly into the bladder)

    Group 2: Nadofaragene firadenovec combined with chemotherapy (gemcitabine and docetaxel, administered into the bladder)

    Group 3: Nadofaragene firadenovec combined with immunotherapy (pembrolizumab, administered through intravenous infusion)

  3. Step 3

    Treatment administration

    The treatment will be administered according to your assigned group

    Regular visits will be scheduled for treatment administration

    The medications will be given either directly into your bladder or through an intravenous line, depending on your treatment group

  4. Step 4

    Monitoring and follow-up

    Regular examinations will be performed to check for any signs of cancer recurrence

    Blood tests will be conducted to monitor your overall health

    The study will continue until December 2028

    You will be monitored for side effects throughout the treatment period

  5. Step 5

    Response evaluation

    Your response to treatment will be evaluated by checking for the absence of high-grade cancer recurrence

    Regular bladder examinations will be performed to assess treatment effectiveness

    The main goal is to achieve a complete response, meaning no evidence of high-grade cancer

Who can join the trial?

13 criteria

  • Must be 18 years or older
  • Must have signed an informed consent form before starting any study procedures
  • Must have been diagnosed with bladder cancer that has not responded to BCG therapy (BCG is a type of treatment given directly into the bladder) within the last 12 months
  • Must have received at least 2 courses of BCG treatment within a 12-month period
  • Must have adequate blood test results, including: - Hemoglobin levels (a protein that carries oxygen in blood) - White blood cell count (cells that fight infection) - Platelet count (cells that help blood clot) - Liver function tests - Kidney function tests
  • Must have a life expectancy of more than 2 years according to the doctor
  • Must be able to participate for the entire duration of the study
  • Must have an ECOG status of 2 or less (ability to perform daily activities)
  • Must not have cancer in the upper urinary tract or prostatic urethra
  • Women who can become pregnant must: - Have a negative pregnancy test - Use effective birth control during treatment and for 6 months after - Or be post-menopausal - Or be surgically unable to become pregnant
  • Men must use effective birth control and condoms during treatment and for 3 months after
  • Must have chosen not to have their bladder removed surgically
  • Patients with low-risk prostate cancer may be included if approved by the study doctor

Who cannot join the trial?

14 criteria

  • Previous treatment with any gene therapy or viral therapy for bladder cancer
  • Active or history of autoimmune disease (a condition where the immune system attacks healthy cells)
  • Current urinary tract infection or bladder inflammation
  • Cancer that has spread beyond the bladder wall (metastatic disease)
  • Previous major surgery within 4 weeks before starting the study
  • Presence of other types of cancer in the last 2 years
  • Serious heart conditions or uncontrolled high blood pressure
  • Pregnant or breastfeeding women
  • Known allergies to any of the study medications
  • Current participation in other clinical trials
  • Severe kidney or liver problems
  • Active or chronic infections like hepatitis B, hepatitis C, or HIV
  • Mental conditions that could affect ability to follow study procedures
  • Use of medications that suppress the immune system
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.

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

  • Nadofaragene firadenovec

    is a gene therapy medication administered directly into the bladder. It works by delivering genetic material to help fight bladder cancer cells in patients who haven't responded well to previous BCG therapy.

  • Gemcitabine

    is a chemotherapy medication that works by blocking the growth of cancer cells and killing them. It's commonly used to treat various types of cancer, including bladder cancer.

  • Docetaxel

    is a chemotherapy medication that works by stopping cancer cells from dividing and growing. It belongs to a class of drugs called taxanes and is used to treat several types of cancer.

  • Pembrolizumab

    is an immunotherapy medication that helps the body's immune system detect and fight cancer cells. It works by blocking a protein that prevents T cells from attacking cancer cells.

  • Bacillus Calmette-Guerin (BCG)

    is a type of immunotherapy made from weakened bacteria. It's administered directly into the bladder to stimulate the immune system to fight bladder cancer cells. This trial focuses on patients whose cancer didn't respond adequately to previous BCG treatment.

What is already known about the treatment

  • Nadofaragene firadenovec

    A gene therapy medication administered through intravesical instillation (directly into the bladder) for treating high-risk non-muscle-invasive bladder cancer that has not responded to BCG therapy. This innovative treatment works by delivering genetic material to bladder cells, helping them produce interferon proteins that fight cancer cells. It belongs to the class of gene therapy agents and represents a novel approach in treating bladder cancer when standard treatments have failed.

  • Gemcitabine

    An anti-cancer chemotherapy drug administered through intravesical instillation for bladder cancer treatment. It works by interfering with cancer cell DNA replication, thereby preventing tumor growth and spread. This medication belongs to the antimetabolite class of chemotherapy drugs and is commonly used in combination therapy for various types of cancer.

  • Docetaxel

    A chemotherapy medication that disrupts cancer cell division by targeting cellular structures called microtubules. When used in bladder cancer treatment, it is administered directly into the bladder through intravesical instillation. This drug belongs to the taxane family of chemotherapy medications and is often used in combination with other cancer treatments.

  • Pembrolizumab

    An immunotherapy medication that helps the body's immune system detect and fight cancer cells by blocking the PD-1 pathway. It is administered through intravenous infusion and belongs to the class of immune checkpoint inhibitors. This medication works by enhancing the ability of T-cells to identify and destroy cancer cells, representing a modern approach to cancer treatment.

Investigated diseases

  • Non-muscle-invasive bladder cancer (NMIBC)

    A type of bladder cancer that affects the inner lining of the bladder without penetrating into the muscle layer. The cancer begins in the cells that line the bladder's inner surface. It can appear as flat growths (carcinoma in situ/CIS) or as mushroom-like tumors (papillary tumors). The condition can occur in multiple areas of the bladder at the same time. Over time, the cancer cells may continue to grow and multiply within the bladder's lining.

  • Carcinoma in situ (CIS) of bladder

    A flat, high-grade cancer confined to the innermost layer of the bladder lining. It appears as reddish, velvet-like patches on the bladder's surface. CIS can be present in one or multiple areas of the bladder. Unlike papillary tumors, these growths remain flat against the bladder wall. The condition is characterized by abnormal cells that have not grown beyond their original location.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512177-27-01Protocol code000434Estimated enrolment240 patientsSponsorFerring Pharmaceuticals A/S

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.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

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).