Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

Official Title

A Phase III, Randomized, Open-Label, Multi-Centre, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Muscle-Invasive Bladder Cancer

Summary:

A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

Trial Description

Primary Outcome:

  • Pathologic complete response (pCR) rates at time of cystectomy
  • Event-free survival (EFS) per central review defined as time from randomization to event
Secondary Outcome:
  • Proportion of patients who achieve
  • EFS at 24 months (EFS24) defined as time from randomization to event
  • Proportion of patients who undergo cystectomy
  • Overall survival rate at 5 years
  • PFS2 defined as time from randomization to event following subsequent therapy
  • Safety and Tolerability as evaluated by adverse events occurring throughout the study
  • Immunogenicity of durvalumab when used in combination with gemcitabine/cisplatin as measured by presence of antidrug antibodies (ADA)

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society