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

Titre officiel

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

Sommaire:

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.

Description de l'essai

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

Voir cet essai sur ClinicalTrials.gov

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