Study on the benefits of combined therapy for high-risk non-muscle invasive bladder cancer

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    What is this study about?

    This research study is focused on investigating the safety and effectiveness of a medication called Pembrolizumab (MK-3475) when combined with Bacillus Calmette-Guerin (BCG) treatment in individuals with high-risk bladder cancer that has not spread to the muscle. The study involves two groups of patients: those who have not responded well to BCG alone and those who have not received BCG previously. For the first group, the primary objective is to determine if the combination of Pembrolizumab and BCG is more effective than BCG alone in eliminating their cancer. For the second group, the goal is to assess whether the combination therapy improves the likelihood of survival without any cancer-related events compared to BCG alone.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Linz , Austria

      Vienna , Austria

      Salzburg , Austria

      Edegem , Belgium

      Yvoir , Belgium

      Aalst , Belgium

      Gent , Belgium

      Gent , Belgium

      Dijon , France

      Suresnes , France

      Rennes , France

      Lille , France

      Cru00e9teil , France

      Munich , Germany

      Weiden In Der Oberpfalz , Germany

      Wuerzburg , Germany

      Trier , Germany

      Jena , Germany

      Patras , Greece

      Chaidari , Greece

      Larissa , Greece

      Pu00e9cs , Hungary

      Szeged , Hungary

      Budapest , Hungary

      Debrecen , Hungary

      Chieti , Italy

      Milano , Italy

      Milan , Italy

      Torino , Italy

      Firenze , Italy

      Bolzano , Italy

      Arezzo , Italy

      Palermo , Italy

      Roma , Italy

      Verona , Italy

      Maastricht , Netherlands

      Rotterdam , Netherlands

      Lorenskog , Norway

      Wroclaw , Poland

      Torun , Poland

      Tarnow , Poland

      Warsaw , Poland

      Przemysl , Poland

      Slupsk , Poland

      Poznan , Poland

      Porto , Portugal

      Lugo , Spain

      Pozuelo de Alarcon , Spain

      Barcelona , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Valencia , Spain

      Inverness , United Kingdom

      London , United Kingdom

      London , United Kingdom

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The steps a patient needs to take in this clinical trial can vary depending on the arm they are assigned to. Here is an example for one of the arms:

      BCG plus Pembrolizumab: Post-induction Cohort A (Arm A-1)

      1. Participants receive BCG, which involves induction and maintenance therapy.
      2. In combination with the BCG, participants are administered 200 mg of pembrolizumab intravenously (IV) every 3 weeks.
      3. This combination treatment is scheduled for 35 doses, which is approximately 2 years.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To be eligible to join the study, you must have a diagnosis of one of the following diseases:

      1. Locally and blinded independent central review (BICR)-confirmed histological diagnosis of high-risk non-muscle invasive urothelial carcinoma (UC) of the bladder, which may include T1, high grade Ta and/or carcinoma in situ (CIS).

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion criteria for the study with explanations of medical terms:

      1. Confirmed diagnosis: Participants must have a histological diagnosis of high-risk non-muscle invasive urothelial carcinoma (UC) of the bladder, confirmed by independent review. This includes T1, high-grade Ta, and/or carcinoma in situ (CIS).
        • T1: Tumor invades the connective tissue beneath the bladder lining but hasn’t spread to muscle.
        • High-grade Ta: Non-invasive but high potential of becoming invasive.
        • CIS: A flat, high-grade cancer that is often difficult to treat.
      2. Cystoscopy/TURBT: Must have undergone a cystoscopy and transurethral resection of bladder tumor (TURBT) procedure to remove all visible tumors. Cystoscopy enables the doctor to see inside the bladder with a camera, and TURBT is the process of removing these tumors.
      3. Tissue for biomarker analysis: Must have provided tissue samples for the purpose of analyzing biological markers that may predict response to therapy.
      4. ECOG performance status: Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, which measures the patient’s ability to perform daily activities.
        • ECOG 0: Fully active, able to carry on all pre-disease activities without restriction.
        • ECOG 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
        • ECOG 2: Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours.
      5. Adequate organ function: Participants need to have normal organ function as determined by medical tests.
      6. Contraception: Male participants must either remain abstinent or use contraception if they are not azoospermic (having no sperm). Female participants should not be pregnant or breastfeeding and if of childbearing potential, must use highly effective contraception or remain abstinent.

      These criteria are designed to ensure patient safety and the integrity of the clinical trial results.

      What Reasons Could Exclude Me from the Study?

      Here is a list of conditions that would exclude you from participating in the study, along with explanations of the medical terms where necessary:

      1. Advanced Urothelial Carcinoma (UC) – History or concurrent advanced stages of bladder cancer (T2, T3, T4 stages) or cancer that has spread beyond the original site.
      2. Concurrent Extra-vesical Urothelial Carcinoma – Presence of non-muscle invasive cancer in areas such as the urethra, ureters, or renal pelvis, either currently or in the past.
      3. Prior Therapy With Certain Immune Agents – Previous treatment with immune checkpoint inhibitors targeting PD-1, PD-L1, PD-L2, or other related T-cell receptors.
      4. Recent Systemic Anti-Cancer Therapy – Receipt of systemic cancer treatments or participation in another drug study within the last 4 weeks.
      5. Immunodeficiency or Immunosuppressive Therapy – Having a weak immune system or being on steroid therapy or any other immune-suppressing medication within 7 days of starting this study.
      6. Another Active Malignancy – Having another cancer that is getting worse or requires treatment, excluding certain skin cancers, within the last 3 years.
      7. Active Autoimmune Disease – Having an illness where the body’s immune system attacks its own cells, which required treatment in the last 2 years.
      8. History of Pneumonitis/Interstitial Lung Disease – Past or current lung conditions that caused inflammation and required steroid treatment.
      9. Contraindications to BCG Treatment – Previous severe reactions to BCG therapy or conditions that prevent safe administration of BCG, such as uncontrollable bladder function.
      10. Active Infection or Systemic Antimicrobial Therapy – Having an ongoing infection or needing antibiotics that affect the whole body.
      11. HIV Infection – Known HIV positive status.
      12. Hepatitis B or C Infection – Known history of Hepatitis B or current active Hepatitis C.
      13. Active Tuberculosis – Current infection with tuberculosis.
      14. Allogenic Tissue/Solid Organ Transplant – Having received a transplant of tissue or an organ from another person.
      15. Contraindication to IV Contrast – Inability to undergo certain imaging procedures because of a reaction to intravenous contrast agents.
      16. Persistent T1 Disease After BCG – Only for Cohort A, participants with persistent stage T1 bladder cancer after BCG therapy are excluded.

      These criteria ensure the safety of the participants and the validity of the study results. If you have any questions about a specific condition or term, please let me know.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are:

      1. Pembrolizumab (KEYTRUDA®) – Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody. It is a type of immunotherapy drug that works by enhancing the body’s immune response against cancer cells. Specifically, it helps the immune system to detect and fight cancer cells by blocking the PD-1 pathway, which can be exploited by tumor cells to evade the immune response.
      2. BCG (TICE® BCG/OncoTICE®) – Bacillus Calmette–Guérin (BCG) is a form of immunotherapy used primarily for bladder cancer treatment. It is a vaccine strain of live attenuated Mycobacterium bovis that stimulates the immune system to fight against cancer in the bladder wall by creating a local inflammatory response. BCG is typically administered directly into the bladder through a catheter (known as intravesical therapy).

      These drugs are being used in different combinations and dosages as part of the clinical trial to investigate their efficacy in treating High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC).

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The clinical trial is using the following active substances that are known to medicine and the medical literature:

      1. Pembrolizumab: This substance is being administered intravenously (IV) with a dose of 200 mg every 3 weeks (Q3W) for participants who are part of the BCG Post-Induction Cohort (Cohort A). Alternately, for participants in the BCG Naïve Cohort (Cohort B), Pembrolizumab is given IV with a dose of 400 mg every 6 weeks (Q6W). Pembrolizumab, also known as KEYTRUDA® or MK-3475, is a well-known anti-PD-1 therapy that has been widely studied and approved for the treatment of various types of cancer.
      2. BCG (Bacillus Calmette–Guérin): This is a form of intravesical therapy where BCG powder for instillation fluid is administered directly into the bladder. The treatment includes an initial induction phase followed by a maintenance therapy. BCG therapy is an established treatment for non-muscle invasive bladder cancer and is commonly referred to by trade names such as TICE® BCG or OncoTICE®. It is used to reduce the risk of cancer recurrence and progression.

      Study ID

      CT-EU-00053746

      Recruitment status

      Recruting new patients

      Start of the trial

      5 years ago

      Study phase

      Phase
      III