Status: Closed
Activation Date: 2018DEC21
Closing Date: 2023JAN31
Phase: II
Description: A Randomized Phase II Trial Assessing Trimodality Therapy With or Without Adjuvant Durvalumab (MEDI4736) to Treat Patients with Muscle-Invasive Bladder Cancer
Eligibility: Histologic diagnosis of transitional cell carcinoma of the bladder with completion of prior trimodality therapy (surgery, chemotherapy and radiation) at least 42 days prior to study enrollment. Stage T2-T4a N0M0.
Objective: The overall objective of this phase II randomized trial is to determine if Durvalumab when used in combination following standard trimodality therapy improves disease-free-survival when compared to surveillance alone in patients with T2 or more muscle-invasive bladder cancer.
Participation: Limited to invited centres
Lay Description: The purpose of this study is to compare disease-free survival in participants receiving durvalumab after initial treatment, to participants receiving surveillance alone after initial treatment for bladder cancer. The study investigates whether this new type of drug called durvalumab can be used in combination with the initial treatment participants receive for a type of bladder cancer which has grown into the muscle wall of their bladder. Recently, clinical trials have shown that a drug similar to durvalumab can help people with bladder cancer especially in combination with prior treatment.
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Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
GENITO-URINARY | BL13 | 82 | 43 | 14 | 49 |
(Core size is 0.6 mm)
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Fluid SamplesDisease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
GENITO-URINARY | BL13 | 82 | 0 | 0 |
Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
GENITO-URINARY | BL13 | 82 | 50 | 1 | 0 | 0 | 50 | 0 | 48 | 0 |