DURVALUMAB for Muscle-invasive bladder cancer

Inclusion criteria

• {"criterion_text":"-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\n-All patients must have a tumour block from their primary tumour available and consent to release for correlative analyses\n-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\n-Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either english, french or spanish\n-Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements\n-Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre\n-In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient enrollment\n-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\n-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\n-Stage T2-T4a N0M0 at time of diagnosis (AJCC-TNM version 8\n-CT scan of the chest/abdomen/pelvis within 8 weeks from enrollment, showing no evidence of metastatic disease\n-Patients must be ≥ 18 years of age\n-Patients must have a life expectancy greater than 6 months\n-Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix I) and a body weight of > 30kg\n-Patients must have adequate hematologic reserve\n-Patients must have an estimated creatinine clearance ≥ 30 ml/min\n-Patients must have adequate liver function"}

Exclusion criteria

• {"criterion_text":"-Pre-existing medical conditions precluding treatment\n-Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec in screening ECG or history of familial long QT syndrome\n-History of interstitial lung disease\n-Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy\n-Any condition that does not permit compliance with the protocol\n-Live attenuated vaccination administered within 30 days prior to randomization.\n-Any prior carboplatin based therapy\n-Pregnancy or lactating mothers\n-Received prior therapy with anti-PD-1, anti-PD-L1,anti-PD-L2, anti- CD137, anti-CTLA-4) antibody\n-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\n-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\n-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\n-Current or prior use of immunosuppressive medication within 28 days of study entry\n-Peripheral neuropathy ≥ grade 2\n-History of allergic or hypersensitivity reactions to any study drug or their excipients"}

Primary endpoints

• {"endpoint_text":"-Disease-free survival. From randomization to either recurrent (local or distant) bladder cancer, a new primary bladder cancer or death from any cause","definition_or_measurement_approach":"From randomization to either recurrent (local or distant) bladder cancer, a new primary bladder cancer or death from any cause"}

Secondary endpoints

• {"endpoint_text":"-Locoregional Control Rate (LCR) Bladder-intact Disease-Free Survival Overall Survival Evaluable for Adverse Events Evaluable for Quality of Life Assessment Evaluable for Economic Analysis","definition_or_measurement_approach":""}

Spain

Earliest CTIS Part Ii Submission Date

27-03-2024

Latest Decision Or Authorization Date

03-04-2024

Processing Time Days

7

Number Of Sites

8

Number Of Participants

80

Primary sponsor

Full Name

Fundacion Cris De Investigacion Para Vencer El Cancer

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Apices Soluciones S.L.","duties_or_roles":"Codes: 1,12,2,5,8","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Queen's University","duties_or_roles":"Codes: 10,7","organisation_type":"Educational Institution"}

Co-sponsors

• Apices Soluciones S.L.
• Queen's University