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A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
CompletedPhase 2
Sponsor: Hoffmann-La Roche
Conditions: Cervical Cancer
Interventions: Tiragolumab, Atezolizumab
Countries: United States, Australia, Brazil, Canada, Costa Rica, France, Italy, Mexico
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).
Eligibility overview
Sex: FEMALE
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Locations (58)
- Phoenix, Arizona, United States
- Irvine, California, United States
- Augusta, Georgia, United States
- Eugene, Oregon, United States
- South Brisbane, Queensland, Australia
- Salvador, Estado de Bahia, Brazil
- Goiânia, Goiás, Brazil
- Ijuí, Rio Grande do Sul, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- São Paulo, São Paulo, Brazil
- Barrie, Ontario, Canada
- London, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Montreal, Quebec, Canada
- San José, Costa Rica
- San José, Costa Rica
- Lyon, France
- Marseille, France
- Montpellier, France
- Saint-Herblain, France
- Villejuif, France
- Naples, Campania, Italy
- Rome, Lazio, Italy
- Milan, Lombardy, Italy
- Monterrey, Nuevo León, Mexico
- Panama City, Panama
- Panama City, Panama
- San Isidro, Peru
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