Cervical Cancer
Conditions
Brief 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).
Interventions
DRUGTiragolumab
Tiragolumab at a fixed dose of 600 milligrams (mg) will be administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
DRUGAtezolizumab
Atezolizumab at a fixed dose of 1200 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-crossover Period: Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR) | From randomization up to approximately 17 months | ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the IRC according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR=Disappearance of all target \& non-target lesions or any pathological lymph nodes (whether target or non-target) have reduction in short axis to \<10 millimeters (mm). PR=At least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. The study enrolled participants with measurable disease as determined by the investigator. Participants found to have non-measurable disease at baseline according to RECIST v1.1 (through IRC assessment or Protocol Deviations) were only considered responders if they achieved a CR. Percentages have been rounded off. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre- and Post-crossover Periods: Number of Participants With Adverse Events (AEs) | Up to approximately 50.3 months | An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Pre-crossover Period: IRC-assessed Duration of Response (DOR) | First occurrence of a documented objective response to the date of PD or death from any cause, whichever occurred first (up to approximately 17 months) | DOR was defined for participants who had objective response (OR) as time from first occurrence of a documented OR (CR/PR) to date of PD or death from any cause (whichever occurred first), determined by IRC per RECIST v1.1. CR=Disappearance of all target \& non-target lesions or any pathological lymph nodes (whether target/non-target) have reduction in short axis to \<10 mm. PR=≥30% decrease in SOD of all target lesions, taking as reference baseline SOD, in absence of CR. PD = ≥ 20% increase in SOD of target lesions, taking as reference smallest SOD at prior timepoints (including baseline); in addition to relative increase of 20%, SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s). Study enrolled participants with measurable disease as per investigator. Participants who had non-measurable disease at baseline according to RECIST v1.1 (IRC assessment or Protocol Deviations) were only considered responders if they achieved CR. |
| Pre-crossover Period: IRC-assessed Disease Control Rate (DCR) | From randomization up to approximately 17 months | DCR was defined as the percentage of participants with a CR, PR, or stable disease (SD), as determined by the IRC according to RECIST v1.1. CR and PR were defined the same as in the description of primary outcome measure (OM), ORR. SD=Neither sufficient shrinkage to qualify for CR/PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments ≥6 weeks apart. PD = ≥ 20% increase in SOD of target lesions, taking as reference smallest SOD at prior timepoints (including baseline); in addition to relative increase of 20%, SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s). Study enrolled participants with measurable disease as per the investigator. Participants who had non-measurable disease at baseline per RECIST v1.1 (IRC assessment or Protocol Deviations) were only considered responders if they achieved CR. |
| Pre-crossover Period: Investigator-assessed Best Clinical Response (BCR) Rate | From randomization up to approximately 17 months | BCR was defined as the percentage of participants with a CR, PR, or SD, as determined by the investigator according to RECIST v1.1. CR=Disappearance of all target \& non-target lesions or any pathological lymph nodes (whether target/non-target) have reduction in short axis to \<10 mm. PR=At least a 30% decrease in SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. SD=Neither sufficient shrinkage to qualify for CR/PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments ≥6 weeks apart. PD=At least 20% increase in SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline); in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s). Percentages have been rounded off. |
| Pre-crossover Period: Investigator-assessed Duration of BCR | First occurrence of a documented clinical response to the date of PD or death from any cause, whichever occurred first (up to approximately 17 months) | Duration of BCR was defined for BCR responders as the time from first occurrence of a documented response (CR, PR, or SD) to date of PD or death from any cause (whichever occurred first), as clinically determined by the investigator according to RECIST v1.1. CR=Disappearance of all target \& non-target lesions or any pathological lymph nodes (whether target/non-target) have reduction in short axis to \<10 mm. PR = ≥30% decrease in SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. SD=Neither sufficient shrinkage to qualify for CR/PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments ≥6 weeks apart. PD = ≥20% increase in SOD of target lesions, taking as reference smallest SOD at prior timepoints (including baseline); in addition to relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s). |
| Pre-crossover Period: IRC-assessed Progression-free Survival (PFS) | From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 17 months) | PFS was defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first), as determined by the IRC according to RECIST v1.1. PD was defined as at least 20% increase in SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline); in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s). |
| Pre-crossover Period: IRC-assessed PFS Rate at 6 Months | At Month 6 | PFS rate was defined as the percentage of participants who were event-free at 6 months post-randomization, as determined by the IRC according to RECIST v1.1. PFS was defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first), as determined by the IRC according to RECIST v1.1. PD was defined as at least 20% increase in SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline); in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s).. |
| Pre-crossover Period: Overall Survival (OS) | From randomization to death from any cause (up to approximately 17 months) | OS was defined as the time of randomization to death from any cause. |
| Pre-crossover Period: OS Rate at 6 Months and 12 Months | At Months 6 and 12 | OS rate was defined as the percentage of participants who were still alive at 6 months and 12 months. OS was defined as the time of randomization to death from any cause. |
| Pre-crossover Period: Minimum Serum Concentration (Cmin) of Tiragolumab | Predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (1 cycle = 21 days) | — |
| Pre-crossover Period: Maximum Serum Concentration (Cmax) of Tiragolumab | At 30 minutes post-dose on Cycle 1 Day 1 (1 Cycle = 21 days) | — |
| Pre-crossover Period: Cmin of Atezolizumab | Predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (1 cycle = 21 days) | — |
| Pre-crossover Period: Cmax of Atezolizumab | At 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle = 21 days) | — |
| Pre-crossover Period: Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab | Up to approximately 17 months | Participants were considered treatment-emergent ADA-positive if they were ADA negative at baseline or missing data but developed an ADA response following study drug administration (treatment-induced ADA response) or if they were ADA-positive at baseline and the titre of one or more post-baseline samples was at least 4-fold greater (i.e., ≥ 0.60 titre units\[t.u\]) than the titre of the baseline sample (treatment-enhanced ADA response). |
| Pre-crossover Period: Percentage of Participants With ADAs to Atezolizumab | Up to approximately 17 months | Participants were considered treatment-emergent ADA-positive if they were ADA negative at baseline or missing data but developed an ADA response following study drug administration (treatment-induced ADA response) or if they were ADA-positive at baseline and the titre of one or more post-baseline samples was at least 4-fold greater (i.e., ≥ 0.60 t.u) than the titre of the baseline sample (treatment-enhanced ADA response). Percentages have been rounded off. |
Countries
Australia, Brazil, Canada, Costa Rica, France, Italy, Mexico, Panama, Peru, Poland, Russia, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Participant flow
Recruitment details
A total of 172 participants took part in the study at 59 investigative sites across 17 countries from 30 June 2020 to 24 February 2025. 1 participant was enrolled but not treated. The study is considered "Completed" because all the pre-planned study activities and analyses have been performed.
Pre-assignment details
Participants with programmed death-ligand 1 (PDL1)-positive cervical cancer in the pre-crossover period were randomized in a 3:1 ratio to receive either atezolizumab plus tiragolumab or atezolizumab monotherapy. Participants in the atezolizumab monotherapy arm with unequivocal disease progression (PD) were given the option to crossover and receive atezolizumab + tiragolumab in the crossover period. Crossover was allowed at investigator's discretion, after consultation with Medical Monitor.
Participants by arm
| Arm | Count |
|---|---|
| Atezolizumab Participants received atezolizumab monotherapy until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator. | 45 |
| Tiragolumab Plus Atezolizumab Participants received tiragolumab and atezolizumab until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator. | 126 |
| Total | 171 |
Baseline characteristics
| Characteristic | Atezolizumab | Tiragolumab Plus Atezolizumab | Total |
|---|---|---|---|
| Age, Continuous | 51.0 years STANDARD_DEVIATION 11.8 | 50.8 years STANDARD_DEVIATION 11.8 | 50.9 years STANDARD_DEVIATION 11.7 |
| ECOG Performance Status ECOG Performance Status 0 | 23 Participants | 55 Participants | 78 Participants |
| ECOG Performance Status ECOG Performance Status 1 | 22 Participants | 71 Participants | 93 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 18 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 81 Participants | 113 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 27 Participants | 33 Participants |
| Prior Use of Chemoradiotherapy or Radiotherapy No | 9 Participants | 28 Participants | 37 Participants |
| Prior Use of Chemoradiotherapy or Radiotherapy Yes | 36 Participants | 98 Participants | 134 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 16 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 27 Participants | 34 Participants |
| Race (NIH/OMB) White | 28 Participants | 79 Participants | 107 Participants |
| Sex: Female, Male Female | 45 Participants | 126 Participants | 171 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Treatment History Persistent Disease | 19 Participants | 61 Participants | 80 Participants |
| Treatment History Recurrent Disease | 26 Participants | 65 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 23 / 45 | 89 / 126 | 10 / 17 |
| other Total, other adverse events | 36 / 45 | 109 / 126 | 14 / 17 |
| serious Total, serious adverse events | 12 / 45 | 42 / 126 | 1 / 17 |
Outcome results
Primary
Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions \>/=4 weeks apart, as determined by the IRC according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. The study enrolled patients with measurable disease as determined by the investigator. Participants found to have non-measurable disease at baseline according to RECIST v1.1 (through IRC assessment or Protocol Deviations) were only considered responders if they achieved a CR.
Time frame: From randomization up to approximately 17 months
Population: The Treated Population was defined as all randomized participants that received at least any dose of study treatment. Participants are grouped according to the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atezolizumab | Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR) | 15.6 percentage of participants |
| Tiragolumab Plus Atezolizumab | Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR) | 19.0 percentage of participants |
Secondary
Investigator-Assessed Best Clinical Response (BCR) Rate
BCR is defined as the percentage of participants with a CR, PR, or SD, as determined by the investigator. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments \>/= 6 weeks apart.
Time frame: From randomization up to approximately 17 months
Population: The Treated Population was defined as all randomized participants that received at least any dose of study treatment. Participants are grouped according to the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atezolizumab | Investigator-Assessed Best Clinical Response (BCR) Rate | 33.3 percentage of participants |
| Tiragolumab Plus Atezolizumab | Investigator-Assessed Best Clinical Response (BCR) Rate | 44.4 percentage of participants |
Secondary
Investigator-Assessed Duration of BCR
Duration of BCR is defined for BCR responders as the time from the first occurrence of a documented response (CR, PR, or SD) to the date of PD or death from any cause (whichever occurred first), as clinically determined by the investigator according to RECIST v1.1. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments \>/= 6 weeks apart. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline).
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 approximately 17 months)
Population: The Treated Population was defined as all randomized participants that received at least any dose of study treatment. Participants are grouped according to the actual treatment received. Duration of BCR was assessed in participants with a clinical response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Atezolizumab | Investigator-Assessed Duration of BCR | 7.0 months |
| Tiragolumab Plus Atezolizumab | Investigator-Assessed Duration of BCR | 5.5 months |
Secondary
IRC-Assessed Disease Control Rate (DCR)
Disease control rate is defined as the percentage of participants with a CR, PR, or stable disease (SD), as determined by the IRC according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments \>/= 6 weeks apart. The study enrolled patients with measurable disease as determined by the investigator. Participants found to have non-measurable disease at baseline according to RECIST v1.1 (through IRC assessment or Protocol Deviations) were only considered responders if they achieved a CR.
Time frame: From randomization up to approximately 17 months
Population: The Treated Population was defined as all randomized participants that received at least any dose of study treatment. Participants are grouped according to the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atezolizumab | IRC-Assessed Disease Control Rate (DCR) | 20.0 percentage of participants |
| Tiragolumab Plus Atezolizumab | IRC-Assessed Disease Control Rate (DCR) | 31.0 percentage of participants |
Secondary
IRC-Assessed Duration of Response (DOR)
DOR is defined for participants who had an objective response as the time from the first occurrence of a documented objective response (CR or PR) to the date of progressive disease (PD) or death from any cause (whichever occurred first), as determined by the IRC according to RECIST v1.1. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). The study enrolled patients with measurable disease as determined by the investigator. Participants found to have non-measurable disease at baseline according to RECIST v1.1 (through IRC assessment or Protocol Deviations) were only considered responders if they achieved a CR.
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 approximately 17 months)
Population: The Treated Population was defined as all randomized participants that received at least any dose of study treatment. Participants are grouped according to the actual treatment received. DOR was assessed in participants with an objective response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Atezolizumab | IRC-Assessed Duration of Response (DOR) | NA months |
| Tiragolumab Plus Atezolizumab | IRC-Assessed Duration of Response (DOR) | 11.8 months |
Secondary
IRC-Assessed PFS Rate at 6 Months
PFS rate is defined as the percentage of participants that were event free, as determined by the IRC according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline).
Time frame: 6 months
Population: The Treated Population was defined as all randomized participants that received at least any dose of study treatment. Participants are grouped according to the actual treatment received. Overall number analyzed are number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoints
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atezolizumab | IRC-Assessed PFS Rate at 6 Months | 21.50 percentage of participants |
| Tiragolumab Plus Atezolizumab | IRC-Assessed PFS Rate at 6 Months | 30.56 percentage of participants |
Secondary
IRC-Assessed Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first), as determined by the IRC according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline).
Time frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 17 months)
Population: The Treated Population was defined as all randomized participants that received at least any dose of study treatment. Participants are grouped according to the actual treatment received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Atezolizumab | IRC-Assessed Progression-Free Survival (PFS) | 1.9 months |
| Tiragolumab Plus Atezolizumab | IRC-Assessed Progression-Free Survival (PFS) | 2.8 months |
Secondary
OS Rate at 6 Months and 12 Months
Reported here are the percentages of participants who were still alive at 6 months and 12 months.
Time frame: 6 months, 12 months
Population: The Treated Population was defined as all randomized participants that received at least any dose of study treatment. Overall number analyzed are number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atezolizumab | OS Rate at 6 Months and 12 Months | 6 Months | 69.49 percentage of participants |
| Atezolizumab | OS Rate at 6 Months and 12 Months | 12 Months | 37.88 percentage of participants |
| Tiragolumab Plus Atezolizumab | OS Rate at 6 Months and 12 Months | 12 Months | 47.19 percentage of participants |
| Tiragolumab Plus Atezolizumab | OS Rate at 6 Months and 12 Months | 6 Months | 73.56 percentage of participants |
Secondary
Overall Survival (OS)
OS is defined as the time of randomization to death from any cause.
Time frame: From randomization to death from any cause (up to approximately 17 months)
Population: The Treated Population was defined as all randomized participants that received at least any dose of study treatment. Participants are grouped according to the actual treatment received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Atezolizumab | Overall Survival (OS) | 10.6 months |
| Tiragolumab Plus Atezolizumab | Overall Survival (OS) | 11.0 months |
Secondary
Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: Up to 36 months
Other Pre-specified
Cmax of Atezolizumab
Time frame: Day 1 of Cycle 1 at 30 minutes post-dose
Other Pre-specified
Cmin of Atezolizumab
Time frame: Pre dose: Day 1 of Cycles 2, 3, 4, 8, 12 and 16
Other Pre-specified
Maximum Serum Concentration (Cmax) of Tiragolumab
Time frame: Cycle 1 Day 1 at 30 minutes post-dose
Other Pre-specified
Minimum Serum Concentration (Cmin) of Tiragolumab
Time frame: Pre dose: Day 1 of Cycles 2, 3, 4, 8, 12 and 16
Other Pre-specified
Percentage of Participants With ADAs to Atezolizumab
Participants were classified as treatment-emergent ADA-positive if they were ADA negative at baseline or missing data but developed an ADA response following study drug administration (treatment-induced ADA response) or if they were ADA-positive at baseline and the titre of one or more post-baseline samples was at least 4-fold greater (i.e., ≥ 0.60 titre units) than the titre of the baseline sample (treatment-enhanced ADA response).
Time frame: Predose on Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12 and 16
Other Pre-specified
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
Participants were classified as treatment-emergent ADA-positive if they were ADA negative at baseline or missing data but developed an ADA response following study drug administration (treatment-induced ADA response) or if they were ADA-positive at baseline and the titre of one or more post-baseline samples was at least 4-fold greater (i.e., ≥ 0.60 titre units) than the titre of the baseline sample (treatment-enhanced ADA response).
Time frame: Predose on Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12 and 16