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Ongoing Clinical Trials for Bladder Cancer

This article provides detailed information about 43 ongoing clinical trials investigating new treatments for bladder cancer. These studies are testing various therapeutic approaches including immunotherapy, chemotherapy combinations, targeted therapies, and novel drug delivery systems for patients with different stages of bladder cancer, from non-muscle invasive to advanced metastatic disease.

Clinical trial locations

Study comparing BCG and combination of BCG with electromotive mitomycin-C treatment in patients with high-risk non-muscle-invasive bladder cancer

This study evaluates treatments for high-risk non-muscle-invasive bladder cancer in patients who have undergone transurethral resection. The research compares two approaches: BCG (Bacillus Calmette-Guérin) therapy alone versus a combination of BCG with electromotive mitomycin-C.

Main focus: The primary goal is to determine which treatment approach is more effective in preventing cancer recurrence or progression over a 12-month treatment period.

Inclusion criteria: Patients must have confirmed high-risk non-muscle-invasive bladder cancer through tissue examination, have undergone at least two surgical tumor removals (TURBT), and be between 18-65 years of age with adequate health status. Imaging must confirm no cancer spread to other body areas.

Exclusion criteria: The study excludes patients younger than 18 or older than 65, those with current or previous muscle-invasive bladder cancer, active infections, tuberculosis, severely weakened immune systems, pregnancy, breastfeeding, or severe bleeding disorders.

Investigational drugs: BCG is administered directly into the bladder to stimulate immune response against cancer cells. Mitomycin-C is a chemotherapy drug delivered through electromotive drug administration (EMDA), which uses mild electric current to enhance bladder wall penetration. The combination therapy aims to provide better cancer control than either treatment alone.

Study of AZD9574 and Temozolomide for Patients with Advanced Solid Tumors, Including Breast, Ovarian, Pancreatic, and Prostate Cancers

This clinical trial investigates AZD9574, a new medication being tested alone and combined with other anti-cancer treatments for patients with advanced solid tumors. The study includes various cancer types such as IDH-mutant glioma, HER2-negative breast cancer, ovarian cancer, prostate cancer, and pancreatic cancer, particularly those with specific genetic mutations (BRCA1, BRCA2, PALB2, RAD51C, or RAD51D).

Main focus: The study assesses the safety, tolerability, and effectiveness of AZD9574 in treating advanced malignancies. Researchers monitor how the body processes the drug and evaluate its initial effectiveness in fighting cancer.

Inclusion criteria: Patients must be at least 18 years old, provide written informed consent, have confirmed advanced cancer that cannot be surgically removed, and demonstrate disease progression through imaging. At least one measurable tumor must be present, with ECOG performance status of 0-2.

Exclusion criteria: Patients with other cancer types not specified in the study, those outside the age range, or unable to follow study procedures cannot participate. Additional exclusions include pregnancy, breastfeeding, recent participation in other trials, known allergies to study medications, and various serious medical conditions.

Investigational drugs: AZD9574 targets specific proteins on cancer cells, disrupting their growth and survival. Anti-cancer agents used in combination are designed to help fight cancer by targeting and killing cancer cells or stopping their growth.

Study of BT8009 Alone or with Pembrolizumab for Patients with Advanced or Metastatic Bladder Cancer

This trial investigates BT8009, a new treatment for urothelial cancer (bladder and urinary system cancer), both alone and combined with pembrolizumab. Additional medications studied include cisplatin, carboplatin, gemcitabine, and avelumab. The study evaluates how well these treatment combinations work in slowing cancer progression or reducing tumor size.

Main focus: The research compares BT8009 effectiveness when used alone, with pembrolizumab, or with standard chemotherapy regimens. The primary goal is assessing progression-free survival and overall response rate.

Inclusion criteria: Patients must be at least 18 years old with confirmed locally advanced or metastatic urothelial cancer (at least 50% transitional cell type). Measurable disease must be present, with life expectancy of at least 12 weeks and adequate organ function.

Exclusion criteria: Patients with different cancer types, those unable to follow study procedures, with serious interfering health conditions, pregnancy, breastfeeding, recent other cancer treatments, allergies to study medications, or currently participating in other trials are excluded.

Investigational drugs: BT8009 targets cancer cells directly, disrupting their growth. Pembrolizumab helps the immune system recognize and attack cancer cells. Cisplatin and carboplatin are chemotherapy drugs damaging cancer cell DNA. Gemcitabine blocks cancer cell DNA synthesis. Avelumab is maintenance therapy helping the immune system attack cancer cells.

Study of EG-70 for Patients with Non-Muscle Invasive Bladder Cancer Unresponsive to BCG or High-Risk Patients New to BCG or with Incomplete BCG Treatment

This study investigates EG-70, a solution containing special DNA that helps produce Interleukin 12, boosting the immune system to fight cancer cells. The trial focuses on patients whose cancer hasn’t responded to BCG treatment or who haven’t completed BCG treatment.

Main focus: The study evaluates EG-70 effectiveness and safety when administered directly into the bladder. Researchers monitor patient response at 12, 24, 36, and 48 weeks to assess complete response rates (no cancer signs detected).

Inclusion criteria: Patients must have Non-muscle invasive bladder cancer with BCG-unresponsive disease (persistent or recurrent within specified timeframes after BCG treatment), or incomplete BCG treatment. Age must be 18 or older, with adequate bone marrow, renal, and liver function, plus ECOG performance status of 0-2.

Exclusion criteria: Patients with BCG-unresponsive NMIBC who haven’t received or completed BCG treatment, those outside the specified age range, or belonging to vulnerable populations cannot participate.

Investigational drugs: EG-70 is administered directly into the bladder through intravesical instillation, stimulating the immune system to target and destroy cancer cells. It works by enhancing the body’s natural defenses against cancer.

Study of JK06 for Patients with Advanced or Metastatic Cancer

This trial studies JK06, an antibody-drug conjugate treatment for unresectable locally advanced or metastatic cancer. The medication is administered through intravenous infusion for various advanced cancers including non-small cell lung cancer, renal cell carcinoma, urothelial bladder cancer, head and neck squamous cell cancer, breast cancer, gastric/gastroesophageal adenocarcinoma, epithelial ovarian cancer, cervical cancer, endometrial adenocarcinoma, prostate cancer, and soft tissue sarcoma.

Main focus: The study determines JK06 safety and tolerability through dose escalation (Phase 1) and expansion (Phase 2). Treatment is administered every three weeks with close monitoring for side effects and treatment response.

Inclusion criteria: Patients must be at least 18 years old, agree to fresh tumor biopsy if required, have ECOG performance status 0-1, life expectancy ≥12 weeks, and measurable disease. Adequate blood counts, liver function, and use of effective contraception are required.

Exclusion criteria: Recent other cancer treatments, pregnancy, breastfeeding, allergies to study medications, inability to follow procedures, concurrent trial participation, certain heart conditions, uncontrolled infections, recent surgery, or substance abuse history exclude participation.

Investigational drugs: JK06 is a 5T4 antibody-drug conjugate combining an antibody targeting the 5T4 protein on cancer cells with a drug to kill these cells. This targeted approach minimizes damage to normal cells.

Study of mRNA-4157 and BCG for Patients with High-Risk Non-Muscle Invasive Bladder Cancer

This trial investigates treatments for high-risk non-muscle invasive bladder cancer, comparing BCG vaccine alone against the combination of mRNA-4157 (a synthetic genetic material treatment) with BCG. The study aims to determine if this combination improves outcomes compared to BCG monotherapy.

Main focus: The research evaluates whether mRNA-4157 combined with BCG is more effective than BCG alone in preventing cancer recurrence or progression. Participants undergo regular monitoring throughout the study period.

Inclusion criteria: Patients must be 18+ years old, have high-risk non-muscle invasive bladder cancer confirmed through tissue examination, completed at least two TURBT surgeries, no cancer spread confirmed by imaging, ECOG status ≤2, and adequate blood/organ function. Female participants need negative pregnancy tests.

Exclusion criteria: Autoimmune diseases, unsuccessful previous BCG treatment, active/untreated tuberculosis, known allergies to study medications, metastatic disease, significant heart/liver/kidney problems, current trial participation, pregnancy/breastfeeding, recent major surgery, active/chronic infections requiring treatment, previous immunotherapy, mental conditions affecting compliance, and other recent cancers exclude participation.

Investigational drugs: V940 (mRNA-4157) is administered through intramuscular injection, working by stimulating immune response to better recognize and attack cancer cells. BCG is placed directly into the bladder, using weakened bacteria to stimulate immune system response against cancer cells.

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

This trial investigates ONCOFID-P-B, a special formulation of paclitaxel obaluronate, for treating Carcinoma in Situ of the bladder that hasn’t responded to BCG therapy. The medication is administered directly into the bladder through intravesical administration.

Main focus: The study evaluates effectiveness and safety of ONCOFID-P-B for patients unsuccessful with previous therapies. Researchers monitor participants to assess complete response rates at various study points and track response duration, cancer progression, and overall survival.

Inclusion criteria: Patients must provide written consent, be 18+ years old, have BCG-unresponsive Carcinoma in Situ (with or without Ta-T1 papillary disease), adequate organ function, ECOG status 0-2, and complete papillary lesion removal before trial. Women of childbearing potential need negative pregnancy tests and effective contraception.

Exclusion criteria: Patients with different bladder cancer types (not BCG-unresponsive CIS), serious interfering health conditions, inability to follow procedures, pregnancy/breastfeeding, concurrent trial participation, recent other cancers, infections, or allergic reactions to study medications cannot participate.

Investigational drugs: ONCOFID-P-B combines paclitaxel (chemotherapy interfering with cancer cell DNA) with hyaluronic acid (helps medication remain longer in bladder). This combination targets cancer cells more effectively through intravesical administration.

Study of Sacituzumab Govitecan, Zimberelimab, and Domvanalimab for Patients with Muscle Invasive Bladder Cancer Ineligible for Cisplatin Chemotherapy

This trial studies treatments for muscle invasive bladder cancer in patients unable or unwilling to receive cisplatin chemotherapy. The study involves three medications: Sacituzumab govitecan (Trodelvy), Zimberelimab (AB122), and Domvanalimab (AB154), all administered through intravenous infusion.

Main focus: The research evaluates whether combining these medications before and after surgery can improve outcomes compared to standard treatments. The study monitors complete response rates (no cancer signs after treatment) and event-free survival.

Inclusion criteria: Patients must provide written consent, be 18+ years old, have confirmed muscle-invasive bladder cancer (predominantly urothelial), be cisplatin-ineligible or refusing it, be eligible for radical cystectomy, have adequate organ function, ECOG status ≤2, life expectancy ≥12 weeks, and measurable disease.

Exclusion criteria: Different cancer types, previous bladder removal surgery, prior chemotherapy/radiation for bladder cancer, other recent cancers (unless successfully treated >5 years ago), serious heart problems, uncontrolled hypertension, active infections, pregnancy/breastfeeding, and allergies to study drugs exclude participation.

Investigational drugs: Sacituzumab Govitecan is an antibody-drug conjugate targeting cancer cells directly. Zimberelimab helps immune system recognize and attack cancer. Domvanalimab enhances immune response, blocking proteins inhibiting immune activity. All aim to improve treatment effectiveness.

Study of Sasanlimab Treatment as a Bladder-Sparing Strategy in Patients with Muscle Invasive Bladder Cancer

This trial explores sasanlimab, a monoclonal antibody, as a bladder-preserving treatment strategy for muscle-invasive bladder cancer patients. The medication is administered through subcutaneous injection (under the skin).

Main focus: The study evaluates survival rates with intact bladder at 12 months after first sasanlimab dose. Researchers assess whether patients remain alive without requiring cystectomy (bladder removal surgery).

Inclusion criteria: Patients must sign informed consent, be 18+ years old, have localized muscle-invasive urothelial cancer confirmed through tissue samples, be candidates for bladder removal surgery, not have cancer spread confirmed by imaging, be candidates for neoadjuvant therapy with gemcitabine and cisplatin, and have adequate organ/bone marrow function.

Exclusion criteria: Previous other cancers (unless very early stage and completely treated), serious heart problems, uncontrolled hypertension, active infections requiring antibiotics, known allergies to study medication, pregnancy/breastfeeding, drug/alcohol abuse history, concurrent trial participation, recent major surgery, or conditions affecting immune system exclude participation.

Investigational drugs: Sasanlimab is used as maintenance treatment to help keep cancer from returning after initial treatment. It aims to boost immune system’s ability to detect and destroy cancer cells, helping patients live longer without bladder removal or cancer progression.

Study on Erdafitinib and Cetrelimab for Patients with Muscle-Invasive Bladder Cancer Ineligible for Cisplatin Treatment

This trial studies treatments for muscle-invasive bladder cancer in patients unable to receive cisplatin. The study explores erdafitinib (oral tablet) and cetrelimab (intravenous infusion) effectiveness and safety when used alone or combined, particularly for patients with FGFR gene alterations.

Main focus: The research evaluates treatment effectiveness in reducing tumor size or achieving complete cancer disappearance. Safety is assessed by tracking side effects experienced by participants.

Inclusion criteria: Patients must provide written consent, agree to avoid pregnancy/fathering children with proper contraception, be 18+ years old, have confirmed muscle-invasive bladder cancer (urothelial carcinoma ≥50%), be cisplatin-ineligible/refusing, have specific FGFR gene alterations confirmed through tissue testing, ECOG status 0-1, and adequate blood/organ function.

Exclusion criteria: Different cancer types, previous nivolumab/similar medication treatment, severe/uncontrolled medical conditions, pregnancy/breastfeeding, recent trial participation, known drug allergies, active infections, other progressing cancers, autoimmune disease history, recent major surgery, or heart problem history exclude participation.

Investigational drugs: Erdafitinib targets specific genetic changes in cancer cells (FGFR gene alterations) to stop cancer cell growth. Cetrelimab is immunotherapy helping body’s immune system recognize and attack cancer cells. The combination is studied to improve treatment outcomes for cisplatin-ineligible patients.

Summary

This overview presents 43 ongoing clinical trials investigating various treatment approaches for bladder cancer. The trials span multiple countries across Europe, with particularly strong representation in Spain, Italy, France, Germany, and Belgium.

Several notable patterns emerge from these studies. Immunotherapy combinations feature prominently, with multiple trials testing checkpoint inhibitors like pembrolizumab, nivolumab, durvalumab, and atezolizumab, often combined with BCG therapy or chemotherapy. This reflects current research focus on harnessing the immune system to fight bladder cancer.

The trials address different disease stages: non-muscle invasive bladder cancer (NMIBC) studies predominantly test BCG combinations and novel intravesical therapies, while muscle-invasive bladder cancer trials explore perioperative treatments combining immunotherapy with chemotherapy or surgery. Several studies specifically target patients ineligible for cisplatin-based chemotherapy, addressing an important unmet medical need.

Antibody-drug conjugates like sacituzumab govitecan, enfortumab vedotin, and BT8009 represent an emerging treatment approach tested across multiple trials. These targeted therapies aim to deliver chemotherapy directly to cancer cells while minimizing damage to healthy tissue.

Many trials incorporate biomarker testing and genetic profiling, reflecting personalized medicine approaches. Studies often require specific molecular characteristics (PD-L1 expression, FGFR alterations, HER2 mutations) for patient eligibility, enabling more targeted treatment strategies.

The diversity of trial locations provides broad patient access to innovative treatments across Europe, though patients should consult their healthcare providers to determine eligibility and suitability for specific trials.

Ongoing Clinical Trials on Bladder cancer

  • Study of Heart and Blood Vessel Side Effects in Cancer Patients Receiving Immune Checkpoint Inhibitor Drug Combination Treatment

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Hungary

  • Study on the Impact of Cisplatin and Drug Combination on Speech and Cognition in Cancer Patients

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland

  • Study of mRNA-4157 and BCG for Patients with High-Risk Non-Muscle Invasive Bladder Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Germany Greece Hungary Italy +3

  • Study of EG-70 for Patients with Non-Muscle Invasive Bladder Cancer Unresponsive to BCG or High-Risk Patients New to BCG or with Incomplete BCG Treatment

    Recruiting

    1 1
    Investigated diseases:
    France Germany Italy Spain

  • Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Italy Spain

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

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study of JK06 for Patients with Advanced or Metastatic Cancer

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Spain

  • Study comparing BCG and combination of BCG with electromotive mitomycin-C treatment in patients with high-risk non-muscle-invasive bladder cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland

  • Study on the Effectiveness of Gemcitabine Hydrochloride for Patients with Low Grade Bladder Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria

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

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

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