Description:
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).
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
Interventions
Drug | Synonyms | Arms |
---|
Tiragolumab | RO7092284 | Tiragolumab plus Atezolizumab |
Atezolizumab | RO5541267, Tecentriq | Atezolizumab |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Tiragolumab plus Atezolizumab | Experimental | Participants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator. | |
Atezolizumab | Experimental | Participants will receive atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit as determined by the investigator. | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR) |
Time Frame: | From randomization 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: | IRC-Assessed 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: | IRC-Assessed Disease Control Rate (DCR) |
Time Frame: | From randomization up to 36 months |
Safety Issue: | |
Description: | |
Measure: | Investigator-Assessed Best Clinical Response (BCR) Rate |
Time Frame: | From randomization up to 36 months |
Safety Issue: | |
Description: | |
Measure: | Investigator-Assessed 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: | IRC-Assessed Progression-Free Survival (PFS) |
Time Frame: | 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: | IRC-Assessed PFS Rate at 6 Months |
Time Frame: | 6 months |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) |
Time Frame: | 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: | Active, not recruiting |
Lead Sponsor: | Hoffmann-La Roche |
Last Updated
August 12, 2021