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

• Status: Active, not recruiting
• Trial end date: 2023-07-15
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Antibodies, Monoclonal; Atezolizumab

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