Trimodality Therapy With/Out Durvalumab to Treat Patients With Muscle-Invasive Bladder Cancer

Titre officiel

A Randomized Phase II Trial Assessing Trimodality Therapy With or Without Adjuvant Durvalumab to Treat Patients With Muscle-Invasive Bladder Cancer

Sommaire:

Le but de cette étude est de déterminer les effets du durvalumab sur le cancer de la vessie lorsqu’il est administré en association avec un traitement à la suite d’une chirurgie, d’une chimiothérapie et d’une radiothérapie.

Description de l'essai

Primary Outcome:

  • Disease-free survival
Secondary Outcome:
  • Non-muscle invasive bladder cancer recurrence rate
  • Loco-regional control rate between treatment arms at the 12 week visit
  • Patterns of disease recurrence between treatment arms
  • Metastasis-free survival between treatment arms
  • Number and severity of adverse events between treatment arms
  • Quality of Life between treatment arms using Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-BL) questionnaire
  • Cost-effectiveness between treatment arms
  • Cost-utility between treatment arms
This study is looking at whether a type of immunotherapy drug called durvalumab can be safely administered after initial treatment received by a patient. Durvalumab has been tested in many different types of cancers. Durvalumab works by allowing the immune system to detect cancer and reactivate the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. It is unclear if the addition of durvalumab is beneficial in patients with bladder cancer who have completed surgery, radiation therapy and chemotherapy.

Voir cet essai sur ClinicalTrials.gov

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