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Bladder transitional cell carcinoma – Trials in Disease

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Clinical Trials for Bladder Transitional Cell Carcinoma

There are currently 29 ongoing clinical trials investigating new treatments for bladder transitional cell carcinoma. These studies are testing various medications, immunotherapies, and treatment combinations to improve outcomes for patients with different stages of the disease, from non-muscle invasive to advanced forms. Trials are being conducted across multiple European countries, offering patients access to innovative treatment approaches.

Clinical trial locations

Study Comparing Erdafitinib and Mitomycin for Patients with Intermediate-risk Non-muscle Invasive Bladder Cancer with FGFR Gene Alterations

This trial is investigating treatment options for patients who have intermediate-risk non-muscle invasive bladder cancer with specific changes in the FGFR gene. The study compares a novel drug delivery system called TAR-200 that releases erdafitinib directly into the bladder against standard chemotherapy with mitomycin or gemcitabine hydrochloride.

Inclusion criteria: Participants must have confirmed intermediate-risk non-muscle invasive bladder cancer diagnosed within 90 days before enrollment. The cancer must meet specific criteria such as being recurrent low grade, multifocal, or at least 3 centimeters in size. All visible cancer must be completely removed before starting the trial, with absence of disease confirmed through screening procedures. The cancer must also have FGFR gene alterations verified through urine or tumor tissue testing.

Exclusion criteria: Patients with different types of cancer, high-risk disease, recent treatments that might interfere with study results, serious health conditions, or those who are pregnant or breastfeeding cannot participate.

Trial focus: The study aims to evaluate how long it takes for cancer to return or worsen by comparing the TAR-200 erdafitinib delivery system with traditional chemotherapy. Participants will receive either the TAR-200 system placed directly into the bladder or standard chemotherapy administered into the bladder. The treatment period lasts up to 12 months with regular monitoring through cystoscopies and biopsies.

Investigational drugs: TAR-200 is a new delivery system designed to release erdafitinib medication directly into the bladder over time. Erdafitinib works by blocking FGFR proteins that help cancer cells grow. The study also includes mitomycin and gemcitabine hydrochloride as comparison treatments, which are standard chemotherapy options delivered directly into the bladder.

Study of Atezolizumab After Chemo-radiotherapy for Patients with Muscle-invasive Bladder Cancer Not Eligible for Radical Surgery

This clinical trial examines whether adding atezolizumab as maintenance therapy after chemo-radiotherapy can improve outcomes for patients with muscle-invasive bladder cancer who cannot undergo bladder removal surgery. The study focuses on patients who have completed standard treatment combining chemotherapy with radiotherapy of at least 60 Gy.

Inclusion criteria: Participants must be 18 years or older with confirmed muscle-invasive bladder cancer and good organ function, including adequate blood counts, kidney, liver, and heart function. They must have completed chemo-radiotherapy and be unable to have radical cystectomy due to medical reasons, age, other health issues, or personal choice. The first dose of atezolizumab must be given within 30 days after the last radiotherapy session.

Exclusion criteria: Patients with previous different cancers unless fully treated, active infections requiring antibiotics, severe allergic reactions to similar medications, autoimmune diseases, pregnancy or breastfeeding, participation in other trials, serious heart conditions, uncontrolled high blood pressure, or severe liver/kidney disease cannot participate.

Trial focus: The study evaluates whether atezolizumab helps patients remain cancer-free for at least two years after completing chemo-radiotherapy. Atezolizumab is administered as an intravenous infusion at a dose of 1,200 mg. Regular follow-ups include physical examinations, laboratory tests, imaging studies, and cystoscopy procedures at 2 and 5 years to monitor cancer control.

Investigational drug: Atezolizumab is an immunotherapy medication that blocks the PD-L1 protein, helping the immune system recognize and attack cancer cells more effectively. It is used as maintenance therapy to potentially extend the benefits of initial chemo-radiotherapy treatment.

Study of Cabozantinib and Durvalumab for Patients with Advanced Bladder Cancer After Chemotherapy

This study investigates a combination treatment for patients with advanced bladder cancer who have previously received chemotherapy. The trial compares the effectiveness of using cabozantinib and durvalumab together versus using them separately.

Inclusion criteria: Participants must have tried 1 or 2 cisplatin-based chemotherapy treatments that did not work for advanced cancer. They must have good organ function, including adequate white blood cell, platelet, and hemoglobin levels, proper liver and kidney function, and controlled lipase levels. Patients must be able to swallow tablets, weigh more than 30 kilograms, have confirmed bladder cancer diagnosis, and demonstrate good physical function with life expectancy of at least 12 weeks.

Exclusion criteria: The specific exclusion criteria focus on patients with urothelial or non-urothelial histology types of bladder cancer, though detailed information about other exclusions is limited in the source material.

Trial focus: The study evaluates how well the combination of cabozantinib (oral tablets) and durvalumab (intravenous infusion) works together compared to using each medication alone. Participants will be monitored for overall survival and response to treatment throughout the trial period.

Investigational drugs: Cabozantinib works by blocking proteins that help cancer cells grow and spread. Durvalumab is an immunotherapy drug that blocks a protein preventing the immune system from attacking cancer cells, thereby enhancing the body’s natural defenses against the tumor.

Study of Mitomycin-C with Electromotive Drug Administration before Surgery in Patients with Non-Muscle Invasive Bladder Cancer

This study compares two methods of delivering mitomycin C treatment for non-muscle invasive bladder cancer: electromotive drug administration before surgery versus standard passive diffusion after surgery. The research aims to determine if the pre-surgery approach can reduce the need for a second surgery.

Inclusion criteria: Patients must have suspected bladder cancer confirmed by examination, with either first-time papillary tumors or returning low-grade tumors. They must have normal kidney function with creatinine less than 1.12 mg/dl and normal liver function meeting specific test limits. Participants must be adults aged 18 or older and provide written consent to participate.

Exclusion criteria: Patients below 18 or above 75 years, those with muscle-invasive bladder cancer history, recent mitomycin C treatment within 6 months, known allergies to mitomycin C, active urinary infections, pregnancy or breastfeeding, severe kidney or liver disease, other active cancers, inability to follow study procedures, medical conditions interfering with bladder treatment, current participation in other trials, or mental conditions preventing informed consent cannot participate.

Trial focus: Participants are randomly assigned to receive either mitomycin C through electromotive drug administration before transurethral resection or passive diffusion after the procedure. The electromotive method uses mild electrical current to help medication penetrate bladder tissue more effectively. Follow-up monitoring continues until April 2028 to track tumor recurrence and recovery.

Investigational drug: Mitomycin C is a chemotherapy medication administered directly into the bladder. In this trial, it works by interfering with cancer cell growth through DNA cross-linking. The electromotive delivery method aims to improve medication penetration into bladder tissue compared to standard instillation.

Study on Bladder Cancer: Testing Cisplatin and Drug Combination for Patients with Non-Muscle Invasive Bladder Cancer

This trial investigates whether giving chemotherapy directly into the bladder before surgery can help prevent cancer from returning. The study compares patients who receive pre-surgery chemotherapy with those who undergo surgery without this treatment.

Inclusion criteria: Patients must be 18 years or older with clinical or imaging evidence of bladder cancer requiring transurethral resection of bladder tumor. They must have a history of non-muscle invasive bladder cancer without carcinoma in situ and have been disease-free for at least 6 months. Participants need a Karnofsky scale score greater than 70%, must agree to participate and sign informed consent, and have tumors smaller than 3 cm.

Exclusion criteria: Patients with muscle-invasive bladder cancer, previous neoadjuvant chemotherapy, other uncontrolled cancers, serious health conditions interfering with the study, pregnancy or breastfeeding, inability to follow study procedures, or concurrent participation in another trial cannot join.

Trial focus: The study involves administering chemotherapy medications including cisplatin, doxorubicin hydrochloride, mitomycin, gemcitabine, docetaxel, and epirubicin hydrochloride directly into the bladder before transurethral resection. Regular follow-ups monitor patients for cancer recurrence through clinical evaluations and imaging tests. The trial is expected to conclude by May 2029.

Investigational drugs: The study uses multiple chemotherapy agents delivered directly into the bladder. These medications work by interfering with cancer cell DNA to prevent multiplication and growth. The transurethral resection procedure removes visible bladder tumors as part of standard treatment.

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

This study evaluates a treatment combination of cisplatin, nab-paclitaxel, and nivolumab alongside radiotherapy following tumor removal surgery. The research aims to assess disease-free survival rates after this multi-modal treatment approach.

Inclusion criteria: Participants must be 18 years or older with non-metastatic muscle invasive bladder cancer diagnosis confirmed by imaging. They must have attempted maximal tumor resection within 56 days before treatment or have recent cystoscopy showing no residual disease. Patients need adequate organ function, ECOG performance status of 1 or better, life expectancy exceeding 6 months, and must be deemed able to tolerate treatment by both radiation and medical oncologists. Women of childbearing potential must use effective birth control during the study and for 5 months after, while men must use birth control for 6 months after treatment.

Exclusion criteria: Patients with metastatic cancer, incomplete tumor resection, inability to receive the study medications or radiotherapy, or those from vulnerable populations cannot participate.

Trial focus: The treatment combines three medications given intravenously: cisplatin (which damages cancer cell DNA), nab-paclitaxel (which stops cell division), and nivolumab (which enhances immune system response). These are administered alongside radiotherapy. Regular monitoring assesses treatment effectiveness and side effects, with follow-up visits scheduled to track health status and long-term effects.

Investigational drugs: Cisplatin is a platinum-based chemotherapy that binds to DNA causing cell death. Nab-paclitaxel interferes with microtubules to stop cancer cell growth. Nivolumab blocks the PD-1 protein on immune cells, enhancing the body’s natural cancer-fighting ability.

Study on Mitomycin and BCG for Patients with Recurrent Non-Muscle Invasive Bladder Cancer

This trial compares chemoablation treatment with mitomycin against standard transurethral resection followed by BCG therapy in patients with recurrent non-muscle invasive bladder cancer. The study aims to determine long-term effectiveness of these different approaches.

Inclusion criteria: Patients must have tumor recurrence after previous low-grade bladder cancer, with tumors smaller than 2 centimeters. Optional negative urine cytology can be included. Participants must be at least 18 years old and able to understand both written and spoken information about the study.

Exclusion criteria: Patients with muscle-invasive bladder cancer, other types of cancer, major surgery within 4 weeks, severe heart or kidney problems, pregnancy or breastfeeding, inability to follow study procedures, or current participation in another clinical trial cannot join.

Trial focus: Participants are randomly assigned to receive either mitomycin C through chemoablation (medication applied directly to the bladder) or transurethral resection followed by BCG therapy. The study monitors participants for up to five years to assess long-term effects, tumor recurrence, and overall health outcomes. Regular follow-up visits include medical examinations and tests as needed.

Investigational drugs: Mitomycin C is a chemotherapy drug that stops cancer cells from growing and multiplying, delivered directly to the bladder through chemoablation. BCG therapy uses weakened bacteria placed into the bladder through a catheter to stimulate the immune system to fight cancer cells. Intravesical instillation therapy involves placing liquid medication directly into the bladder after tumor removal to prevent cancer recurrence.

Study on the Effectiveness and Safety of Mitomycin C with Electric Current for Treating Non-Muscle Invasive Bladder Cancer in Patients, Compared to Standard Immunotherapy

This study compares supportive treatment using mitomycin C with electromotive drug administration against standard BCG immunotherapy for high-grade non-muscle invasive bladder cancer. The research evaluates effectiveness, safety, and tumor detection methods.

Inclusion criteria: Patients must be over 18 years with life expectancy of at least 5 years and able to give informed consent. They must have high-grade non-muscle invasive bladder cancer at stages Ta or T1, confirmed through transurethral resection with follow-up procedures as needed. A second resection is required for all T1 tumors and for Ta tumors if initial resection was incomplete or lacked muscle samples. Random bladder biopsies must be negative for carcinoma in situ, and muscle presence must be confirmed in tissue samples.

Exclusion criteria: Patients with medical conditions other than non-muscle invasive bladder cancer, those outside the specified age range, or members of vulnerable populations cannot participate.

Trial focus: Treatment involves six weekly sessions of mitomycin delivered directly into the bladder using electromotive drug administration, followed by one year of maintenance therapy. This is compared with BCG treatment following the same schedule. The study monitors disease-free survival and uses a urinary biomarker called MCM5 ADXBLADDER to detect tumor recurrence, comparing it with traditional methods like urinary cytology and cystoscopy.

Investigational drugs: EMDA-MMC combines a medical device with mitomycin C medication. The device helps medication work more effectively by applying it directly to the bladder using electrical enhancement. BCG is standard treatment involving weakened bacteria placed directly into the bladder to stimulate immune system response against cancer cells. Both treatments follow similar schedules with weekly initial sessions and maintenance therapy.

Study of TYRA-300-B01 tablets in patients with low grade, intermediate risk non-muscle invasive bladder cancer who have FGFR3 gene changes

This study tests a new oral medication called TYRA-300 for patients with low-grade, intermediate-risk non-muscle invasive bladder cancer who have specific FGFR3 gene changes. The research evaluates how well the medication works and its safety profile.

Inclusion criteria: Participants must be 18 years or older with diagnosed low-grade bladder cancer confirmed within 6 weeks before study start. They must have visible tumors between 3 mm and 12 mm serving as marker lesions and intermediate-risk cancer features including recurrence within one year, single tumor larger than 3cm, multiple tumors, or cancer grown into tissue beneath bladder lining. Patients must have FGFR3 genetic changes, complete bladder mapping within 6 weeks, no cancer in upper urinary tract or prostate channel within 6 months, no BCG treatment within one year, no bladder medication within 8 weeks, good physical function, purely bladder-origin cancer cells, and adequate bone marrow, liver, and kidney function.

Exclusion criteria: Patients with known allergies to TYRA-300, other cancers within 5 years except treated skin cancer, pregnancy or breastfeeding, serious heart conditions, severe liver problems, active infections including hepatitis B/C or HIV, major surgery within 4 weeks, recent participation in other trials, mental conditions interfering with procedures, substance abuse, unsafe participation conditions, inability to swallow medications, bleeding problems, or current blood thinner use cannot participate.

Trial focus: The study lasts up to 24 months with regular monitoring of tumor response, particularly after 3 months. Blood tests measure medication processing, and health assessments continue throughout to monitor side effects and cancer changes. The trial is expected to continue until August 2028.

Investigational drug: TYRA-300 is an oral tablet specifically targeting cancers with FGFR3 alterations. It works by blocking signals that cause cancer cells to grow and spread, designed for non-muscle invasive bladder cancer that hasn’t penetrated the muscle layer.

Study on Hexaminolevulinate for Patients with Non-Muscle Invasive Bladder Cancer to Reduce Need for Second Surgery

This trial compares Photodynamic Trans-urethral Resection using Hexvix against conventional white-light surgery followed by potential second surgery. The study aims to determine if the enhanced visualization method can eliminate the need for additional procedures.

Inclusion criteria: Patients must be at least 18 years old with clinical suspicion of primary or recurrent bladder cancer advised to undergo transurethral resection. They must have confirmed non-muscle invasive bladder cancer and be candidates for second-look resection per European guidelines. No imaging evidence of muscle-invasive, locally advanced, or metastatic cancer should exist, with only specific cancer types eligible. Patients must be BCG-naïve (not previously treated with BCG immunotherapy), fit for all study procedures, and able to provide written informed consent.

Exclusion criteria: Patients with different bladder cancer types, those outside the specified age range, or members of vulnerable populations cannot participate.

Trial focus: Participants are randomly assigned to either photodynamic diagnosis assisted surgery using Hexvix or conventional white-light surgery. Hexvix is administered as an intravesical solution before the procedure to enhance tumor visibility. Follow-up cystoscopy occurs at 3 months to check for early recurrence, with additional follow-ups at 4.5 months for late recurrences and disease progression. The study compares outcomes between the two surgical approaches through July 2027, including health and quality of life assessments.

Investigational drug: Hexvix contains hexaminolevulinate, which makes cancer tissues more visible during surgery by causing them to fluoresce under special light. This enhanced visualization aims to improve tumor removal accuracy and potentially reduce the need for repeat surgeries.

Study on Mitomycin, Capecitabine, Ipilimumab, and Nivolumab for Muscle Invasive Bladder Cancer Treatment in Patients Seeking Bladder-Sparing Options

This study evaluates a bladder-sparing treatment combining mitomycin, capecitabine, ipilimumab, and nivolumab with chemoradiotherapy for muscle-invasive bladder cancer patients who cannot or choose not to undergo bladder removal surgery.

Inclusion criteria: Participants must provide written informed consent and demonstrate adequate organ function through laboratory tests conducted within 28 days of registration. They must have muscle-invasive bladder cancer diagnosis with recent transurethral biopsy and maximal resection within 35 days before treatment. Patients with mixed cell types are allowed if more than 50% is urothelial carcinoma, but those with mostly non-urothelial types are excluded. They must be planned for chemoradiotherapy, have ECOG performance status of 0 or 1, and possess bladder function allowing follow-up cystoscopy examinations. Female participants of childbearing potential need negative pregnancy tests and must use effective birth control during the study and for 5 months after, while males must use condoms for 7 months after treatment.

Exclusion criteria: Patients with other cancer types, previous severe allergic reactions to study medications, serious heart problems, uncontrolled high blood pressure, active infections requiring treatment, pregnancy or breastfeeding, autoimmune diseases, recent investigational drug use within 4 weeks, organ transplant history, or drug/alcohol abuse cannot participate.

Trial focus: Treatment involves mitomycin-C, capecitabine, ipilimumab, and nivolumab administered alongside radiotherapy. The medications are given intravenously for mitomycin, ipilimumab, and nivolumab, while capecitabine is taken orally. Regular monitoring assesses treatment response, side effects, and health status throughout the trial.

Investigational drugs: Mitomycin-C interferes with cancer cell DNA to prevent growth. Capecitabine converts into a substance attacking cancer cells to stop their growth. Ipilimumab blocks a protein keeping the immune system in check, allowing better cancer cell attack. Nivolumab blocks proteins preventing immune system from attacking cancer cells, helping the body target and destroy them more effectively.

Summary

The 29 ongoing clinical trials for bladder transitional cell carcinoma demonstrate significant geographic concentration in Western and Central Europe, with particularly strong representation in countries like France, Germany, Italy, Spain, and Belgium. Notable trends include substantial focus on immunotherapy approaches, with multiple trials testing immune checkpoint inhibitors such as atezolizumab, durvalumab, nivolumab, and pembrolizumab, often in combination with other treatments.

A significant portion of trials investigates novel drug delivery systems, particularly TAR-200 combined with cetrelimab, appearing in multiple studies across different disease stages. The research landscape shows clear stratification between non-muscle invasive and muscle-invasive disease, with dedicated trials for each category. Several studies specifically target patients with FGFR gene alterations, reflecting growing understanding of molecular subtypes and personalized medicine approaches.

The trials encompass various treatment settings including neoadjuvant therapy before surgery, adjuvant therapy after surgery, and treatments for patients unable or unwilling to undergo radical cystectomy. Multiple studies compare new approaches against standard treatments like BCG therapy or platinum-based chemotherapy, providing valuable comparative effectiveness data. The geographic distribution and variety of treatment approaches offer European patients diverse opportunities to access innovative therapies through clinical trial participation.

Ongoing Clinical Trials on Bladder transitional cell carcinoma

  • Study of Durvalumab and Tremelimumab for Patients with Advanced Unresectable Urothelial Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Greece Spain

  • Study of erdafitinib versus chemotherapy (gemcitabine or mitomycin) for patients with high-risk non-muscle-invasive bladder cancer with FGFR mutations who failed BCG therapy

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Poland

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