Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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).

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

Keywords

Cervical Cancer Uterine Cervical Neoplasms Atezolizumab Tiragolumab Tiragolumab plus Atezolizumab

Eligibility

You can join if…

Open to females ages 18 years and up

  • Histologically confirmed recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix after 1-2 lines of prior systemic chemotherapy 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 CAN'T join if...

  • Treatment with investigational therapy with therapeutic intent within 28 days prior to randomization
  • Any 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
  • 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

  • UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • Kaiser Permanente - Irvine accepting new patients
    Irvine California 92618 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04300647
Phase
Phase 1/2
Study Type
Interventional
Last Updated