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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

NCT04300647

Description:

The purpose of this study is to evaluate the safety and efficacy 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).

Related Conditions:
  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Carcinoma
  • Cervical Squamous Cell Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: WO42017
  • SECONDARY ID: 2019-004895-21
  • NCT ID: NCT04300647

Conditions

  • Cervical Cancer

Interventions

DrugSynonymsArms
TiragolumabRO7092284Tiragolumab plus Atezolizumab
AtezolizumabRO5541267, TecentriqAtezolizumab

Purpose

The purpose of this study is to evaluate the safety and efficacy 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).

Trial Arms

NameTypeDescriptionInterventions
Tiragolumab plus AtezolizumabExperimentalParticipants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
  • Tiragolumab
  • Atezolizumab
AtezolizumabExperimentalParticipants will receive atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
  • Atezolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed recurrent or persistent squamous cell carcinoma,
             adenosquamous carcinoma, or adenocarcinoma of the cervix after at least 1 line of
             prior therapy 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

          -  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 at the time of randomization

          -  Known human immunodeficiency virus (HIV) infection

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:First occurrence of a documented objective response to the date of disease progression or death from any cause, whichever occurs first (up to 36 months)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Percentage of Participants With Adverse Events
Time Frame:Up to 36 months
Safety Issue:
Description:
Measure:Duration of Response (DOR)
Time Frame:First occurrence of a documented objective response to the date of disease progression or death from any cause, whichever occurs first (up to 36 months)
Safety Issue:
Description:
Measure:Disease Control Rate (DCR)
Time Frame:First occurrence of a documented control date to the date of disease progression or death from any cause, whichever occurs first (up to 36 months)
Safety Issue:
Description:
Measure:Best Clinical Response (BCR) Rate
Time Frame:First occurrence of a documented clinical response to the date of disease progression or death from any cause, whichever occurs first (up to 36 months)
Safety Issue:
Description:
Measure:Progression-Free Survival (PFS)
Time Frame:Time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 36 months)
Safety Issue:
Description:
Measure:PFS Rate at 6 Months
Time Frame:6 months
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:Time from randomization to death from any cause (up to 36 months)
Safety Issue:
Description:
Measure:OS Rate at 6 Months and 12 Months
Time Frame:6 months, 12 months
Safety Issue:
Description:
Measure:Minimum Serum Concentration (Cmin) of Tiragolumab
Time Frame:Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at treatment discontinuation (TD) visit (up to 36 months)
Safety Issue:
Description:
Measure:Maximum Serum Concentration (Cmax) of Tiragolumab
Time Frame:Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months)
Safety Issue:
Description:
Measure:Cmin of Atezolizumab
Time Frame:Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months)
Safety Issue:
Description:
Measure:Cmax of Atezolizumab
Time Frame:Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months)
Safety Issue:
Description:
Measure:Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
Time Frame:Predose on Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months)
Safety Issue:
Description:
Measure:Percentage of Participants With ADAs to Atezolizumab
Time Frame:Predose on Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months)
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Hoffmann-La Roche

Last Updated

March 6, 2020