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Trimodality therapy with or without adjuvant Durvalumab to treat patients with bladder cancer
EU CTIS ID: 2024-512502-26-00
What this study is testing
To determine whether durvalumab given after standard trimodality therapy improves disease-free survival when compared to surveillance alone in patients with T2 or more muscle-invasive bladder cancer
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologic diagnosis of urothelial carcinoma of the bladder. Patients with mixed histology (including small cell) and urothelial carcinoma are eligible. Patients with pure small cell carcinoma will be excluded
- All patients must have a tumour block from their primary tumour available and consent to release for correlative analyses
- Patients have completed prior trimodality therapy (TMT) consisting of surgery, chemotherapy and radiation therapy treatment prior to enrollment on the BL.13 study Patients should begin protocol treatment within 42 days after completion of TMT
- Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either english, french or spanish
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements
- Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre
You likely can't join if
- Pre-existing medical conditions precluding treatment
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec in screening ECG or history of familial long QT syndrome
- History of interstitial lung disease
- Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy
- Any condition that does not permit compliance with the protocol
- Live attenuated vaccination administered within 30 days prior to randomization.
See the full eligibility criteria
Who can join
- Histologic diagnosis of urothelial carcinoma of the bladder. Patients with mixed histology (including small cell) and urothelial carcinoma are eligible. Patients with pure small cell carcinoma will be excluded
- All patients must have a tumour block from their primary tumour available and consent to release for correlative analyses
- Patients have completed prior trimodality therapy (TMT) consisting of surgery, chemotherapy and radiation therapy treatment prior to enrollment on the BL.13 study Patients should begin protocol treatment within 42 days after completion of TMT
- Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either english, french or spanish
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements
- Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre
- In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient enrollment
- Women/men of childbearing potential must have agreed to use a highly effective contraceptive method during and for 3 months following treatment. Women of childbearing potential will have a pregnancy test to determine eligibility as part of the Pre-Study Evaluation
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Stage T2-T4a N0M0 at time of diagnosis (AJCC-TNM version 8
- CT scan of the chest/abdomen/pelvis within 8 weeks from enrollment, showing no evidence of metastatic disease
- Patients must be ≥ 18 years of age
- Patients must have a life expectancy greater than 6 months
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix I) and a body weight of > 30kg
- Patients must have adequate hematologic reserve
- Patients must have an estimated creatinine clearance ≥ 30 ml/min
- Patients must have adequate liver function
What rules you out
- Pre-existing medical conditions precluding treatment
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec in screening ECG or history of familial long QT syndrome
- History of interstitial lung disease
- Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy
- Any condition that does not permit compliance with the protocol
- Live attenuated vaccination administered within 30 days prior to randomization.
- Any prior carboplatin based therapy
- Pregnancy or lactating mothers
- Received prior therapy with anti-PD-1, anti-PD-L1,anti-PD-L2, anti- CD137, anti-CTLA-4) antibody
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease (e.g. colitis or Crohn's disease; not due to radiation reaction), diverticulitis with the exception of diverticulosis, celiac disease (controlled by diet alone) or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), rheumatoid arthritis, hypophysitis, uveitis, etc., within the past 3 years prior to the start of treatment
- Patients with active or uncontrolled intercurrent illness including, but not limited to: • cardiac dysfunction • active peptic ulcer disease or gastritis • active bleeding diatheses • psychiatric illness • Tuberculosis • HIV virus infection.HIV– infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible; • known active hepatitis B infection • known active hepatitis C infection
- History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization* or a prior history of severe immune mediated toxicity from other immune therapy or grade ≥ 3 infusion reaction
- Current or prior use of immunosuppressive medication within 28 days of study entry
- Peripheral neuropathy ≥ grade 2
- History of allergic or hypersensitivity reactions to any study drug or their excipients
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.