A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
Completed · Phase 2
Conditions studied: Cervical Cancer
In brief
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).
Key facts
- Study ID
- NCT04300647
- Run by
- Hoffmann-La Roche
- People needed
- 172
- Starts
- 2020-06-30
- Expected to finish
- 2025-02-24
- Last updated by the study team
- 2026-03-12
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify 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 qualify 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
Where it is running
- Kaiser Permanente - Irvine — Irvine, California, United States
- Augusta University — Augusta, Georgia, United States
- Oncology Associates of Oregon, P.C — Eugene, Oregon, United States
- Mater Misericordiae Limited — South Brisbane, Queensland, Australia
- Hospital Sao Rafael - HSR — Salvador, Estado de Bahia, Brazil
- Hospital Araujo Jorge — Goiânia, Goiás, Brazil
- Hospital de Caridade de Ijui — Ijuí, Rio Grande do Sul, Brazil
- Hospital Sao Lucas - PUCRS — Porto Alegre, Rio Grande do Sul, Brazil
- Hospital Nossa Senhora da Conceicao — Porto Alegre, Rio Grande do Sul, Brazil
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda — São Paulo, São Paulo, Brazil
- Royal Victoria Regional Health Centre — Barrie, Ontario, Canada
- London Regional Cancer Centre — London, Ontario, Canada
- Princess Margaret Cancer Center — Toronto, Ontario, Canada
- Jewish General Hospital — Montreal, Quebec, Canada
- McGill University Health Centre - Glen Site — Montreal, Quebec, Canada
- Clinica CIMCA — San José, Costa Rica
- ICIMED Instituto de Investigación en Ciencias Médicas — San José, Costa Rica
- Centre Leon Berard — Lyon, France
- Institut Paoli Calmettes — Marseille, France
- Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque — Montpellier, France
- ICO - Site René Gauducheau — Saint-Herblain, France
- Gustave Roussy — Villejuif, France
- Istituto Tumori Napoli — Naples, Campania, Italy
- Policlinico Universitario Agostino Gemelli — Rome, Lazio, Italy
- Arizona Oncology Associates — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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