A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer

Titre officiel

A Phase II, Safety, and Efficacy Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Patients With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer

Sommaire:

The purpose of this study is to evaluate the efficacy and safety of tiragolumab in combination with atezolizumab and atezolizumab monotherapy in patients with programmed death-ligand 1 (PD-L1)-positive cervical cancer (metastatic and/or recurrent).

Description de l'essai

Primary Outcome:

  • Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR)
Secondary Outcome:
  • Percentage of Participants With Adverse Events
  • IRC-Assessed Duration of Response (DOR)
  • IRC-Assessed Disease Control Rate (DCR)
  • Investigator-Assessed Best Clinical Response (BCR) Rate
  • Investigator-Assessed DOR
  • IRC-Assessed Progression-Free Survival (PFS)
  • IRC-Assessed PFS Rate at 6 Months
  • Overall Survival (OS)
  • OS Rate at 6 Months and 12 Months
  • Minimum Serum Concentration (Cmin) of Tiragolumab
  • Maximum Serum Concentration (Cmax) of Tiragolumab
  • Cmin of Atezolizumab
  • Cmax of Atezolizumab
  • Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
  • Percentage of Participants With ADAs to Atezolizumab

Voir cet essai sur ClinicalTrials.gov

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