None listed
Conditions
Interventions
Doublet arm Type of group
In the doublet arm, patients will receive atezolizumab at a fixed dose of 1200 mg administered by IV infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle, followed by tiragolumab at a fixed dose of 600 mg administered by IV infusion Q3W also on Day 1 of each 21-day cycle.
Group name:Atezolizumab monotherapy arm Type of group
In the atezolizumab monotherapy arm, patients will receive atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria for study entry: • Signed Informed Consent Form • Age ≥18 years at time of signing Informed Consent Form •Life expectancy ≥12 weeks •Ability to comply with the study protocol •ECOG Performance Status of 0 or 1 •Histologically confirmed recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix (neuroendocrine, clear cell, and sarcoma histologies are not allowed) after 1-2 lines of prior systemic chemotherapy that is not amenable to curative treatment with systemic chemotherapy, surgery, and/or radiotherapy. • Adequate hematologic and end-organ function. • Negative HIV test at screening. • Negative hepatitis B surface antigen (HBsAg) test at screening. • Positive HBsAb test at screening, or negative HBsAb at screening. • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. • For women of childbearing potential: agreement to remain abstinent or use contraception. For more details, review the protocol.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: •FFPE cervical cancer tissue specimens (archival or tissue obtained from biopsy at screening) that is PD-L1 negative, as determined by the investigational VENTANA PD-L1 (SP263) CDx Assay, with negativity defined as TIC< 5%, as determined by a central laboratory • Pregnant or breastfeeding, or intending to become pregnant during study treatment, within 90 days after the final dose of tiragolumab, or within 5 months after the final dose of atezolizumab. Women of childbearing potential must have a negative pregnancy test result within 14 days prior to randomization. •Treatment with investigational therapy with therapeutic intent within 28 days prior to randomization. Planned surgery during the study. •Current treatment with anti-viral therapy for HBV or HCV. •Substance abuse within 12 months prior to screening, in the investigator´s judgment. For more details, review the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:ORR, defined as the proportion of patients with a complete response (CR) or a partial response (PR) on two consecutive occasions≥ 4 weeks apart, as determined by an independent review committee (IRC) according to RECIST v1.1 Measure:Objective response rate (ORR) Timepoints:Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the IRC according to RECIST v1.1. Measure:Duration of response (DOR) Timepoints:Throughout the study ; Outcome name:Disease control rate (DCR), defined as the proportion of patients with a CR, PR, or stable disease (SD), as determined by an IRC according to RECIST v1.1 Measure:Disease control rate (DCR) Timepoints:Throughout the study ; Outcome name:PFS after randomization, defined as the time from randomization to the first occurrence of disease progression, as determined by the IRC according to RECIST v1.1, or death from any cause, whichever occurs first. Measure:Progression-free survival (PFS) Timepoints:Throughout the study | — |
Countries
Australia, Brazil, Canada, Costa Rica, France, Italy, Korea South, Mexico, Poland, Russian Federation, Spain, Taiwan, Thailand, United Kindgdom, United States
Contacts
Public ContactLizeth Perez
ROCHE FARMA (PERU) S.A.
Outcome results
None listed