A clinical trial to evaluate tiragolumab plus atezolizumab and atezolizumab on its own in people with cervical cancer (SKYSCRAPER-04)

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

  • Cancer
  • Cervical Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Active, not recruiting

This trial runs in
Cities
  • Barrie
  • Hamilton
  • London
  • Montréal
  • Toronto
Trial Identifier:

NCT04300647 2019-004895-21 WO42017

      Show trial locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial 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).

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT04300647, WO42017, 2019-004895-21 Trial Identifier
      Tiragolumab, Atezolizumab Treatments
      Cervical Cancer Condition
      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

      Eligibility Criteria

      Female Gender
      ≥18 Years Age
      No Healthy Volunteers
      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

      Clinical Research Explained

      Information about what clinical trials and observational studies are. Understand why you might want to take part in clinical research and why diversity in clinical research is important.

      Find out now