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

Official Title

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

Summary:

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).

Trial Description

Primary Outcome:

• Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR)

• 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

View this trial on ClinicalTrials.gov