A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer

Official Title

A Phase II, Randomized, Double-Blind Placebo-Controlled Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer

Summary:

This study will evaluate the efficacy and safety of atezolizumab with bevacizumab in combination with cisplatin and gemcitabine(CisGem), compared with atezolizumab in combination with CisGem, in participants with advanced biliary tract cancer (BTC) who have not received prior systemic therapy. Treatment will consist of a chemotherapy combination phase followed by a cancer immunotherapy (CIT)/placebo phase.

Trial Description

Primary Outcome:

  • Progression Free Survival (PFS)
Secondary Outcome:
  • Overall Survival (OS)
  • Confirmed Objective Response Rate (ORR)
  • Duration of Response (DOR)
  • Disease Control Rate (DCR)
  • Time to Confirmed Deterioration (TTCD)
  • Percentage of Participants With Adverse Events
  • Serum Concentration of atezolizumab
  • Prevalence of ADAs to Atezolizumab
  • Incidence of ADAs to Atezolizumab

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society