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

Korábbi kezelés

• Treatment with investigational therapy with therapeutic intent within 28 days prior to randomization
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
• Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to randomization
• Treatment with systemic immunosuppressive medications within 1 week prior to randomization or anticipation of need for systemic immunosuppressive medication during study

Más betegség

• Active or history of autoimmune disease or immune deficiency
• Active tuberculosis
• Known, clinically significant liver disease
• Severe infection per investigator judgement at the time of randomization or any active infection that, in the opinion of the investigator, could impact patient safety
• Known hypersensitivity to any component of the tiragolumab or atezolizumab formulations

Egyéb

• Active or untreated central nervous system (CNS) or brain metastases
• Pregnant or breastfeeding woman

• Histologically confirmed recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix after progression on or after 1-2 lines of prior systemic chemotherapy in the metastatic/recurrent setting that is not amenable to curative treatment with systemic chemotherapy, surgery, and/or radiotherapy
• Radiologically-measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance Status of 0 or 1
• Cervical cancer tissue for study analysis (archival or fresh biopsy specimen)
• Life expectancy of at least 12 weeks
• Adequate hematologic and organ function
• Female of childbearing potential must be willing to comply with adequate contraception