Clareo Health | A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
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Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Treatment with investigational therapy with therapeutic intent within 28 days prior to randomization
Active or untreated central nervous system (CNS) or brain metastases
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
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
Pregnant or breastfeeding woman
Known hypersensitivity to any component of the tiragolumab or atezolizumab formulations