Trial Outcomes & Findings for A Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Participants With Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Carcinoma (NCT NCT04540211)

Last Updated: 2026-04-09

Results Overview

PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause (whichever occurred first), as determined by an IRF according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (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). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

461 participants

Primary outcome timeframe

From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 19 months)

Results posted on

2026-04-09

Participant Flow

Participants were recruited from 67 centers across 5 countries/regions in Asia: mainland China, Republic of Korea, Thailand, Taiwan and Hong Kong.

Overall, 461 participants were enrolled and randomized in the study with a 1:1 allocation ratio between treatment arms. Participants received the same drugs as induction and maintenance treatments except for chemotherapy.

Participant milestones

Participant milestones
Measure	Placebo + PC Participants received atezolizumab matching placebo plus tiragolumab matching placebo in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e. atezolizumab matching placebo plus tiragolumab matching placebo on Day 1 of each 21-day cycle until, loss of clinical benefit or unacceptable toxicity.	Atezolizumab + Tiragolumab + PC Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment.
Overall Study STARTED	232	229
Overall Study Safety Population	227	228
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	232	229

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo + PC Participants received atezolizumab matching placebo plus tiragolumab matching placebo in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e. atezolizumab matching placebo plus tiragolumab matching placebo on Day 1 of each 21-day cycle until, loss of clinical benefit or unacceptable toxicity.	Atezolizumab + Tiragolumab + PC Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment.
Overall Study Death	158	129
Overall Study Lost to Follow-up	3	2
Overall Study Withdrawal by Subject	4	4
Overall Study On-going in study	67	94

Baseline Characteristics

A Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Participants With Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo + PC n=232 Participants Participants received atezolizumab matching placebo plus tiragolumab matching placebo in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e. atezolizumab matching placebo plus tiragolumab matching placebo on Day 1 of each 21-day cycle until, loss of clinical benefit or unacceptable toxicity.	Atezolizumab + Tiragolumab + PC n=229 Participants Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment.	Total n=461 Participants Total of all reporting groups
Age, Continuous	62.6 years STANDARD_DEVIATION 8.0 • n=36 Participants	62.3 years STANDARD_DEVIATION 8.2 • n=78 Participants	62.5 years STANDARD_DEVIATION 8.1 • n=23 Participants
Sex: Female, Male Female	26 Participants n=36 Participants	29 Participants n=78 Participants	55 Participants n=23 Participants
Sex: Female, Male Male	206 Participants n=36 Participants	200 Participants n=78 Participants	406 Participants n=23 Participants
Race/Ethnicity, Customized Race: Asian	232 Participants n=36 Participants	229 Participants n=78 Participants	461 Participants n=23 Participants
Race/Ethnicity, Customized Ethnicity: Not Hispanic or Latino	232 Participants n=36 Participants	229 Participants n=78 Participants	461 Participants n=23 Participants

PRIMARY outcome

Timeframe: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 19 months)

Population: Full analysis set (FAS) included all randomized participants regardless of whether they received any study treatment.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab + PC n=229 Participants Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment.	Placebo + PC n=232 Participants Participants received atezolizumab matching placebo plus tiragolumab matching placebo in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e. atezolizumab matching placebo plus tiragolumab matching placebo on Day 1 of each 21-day cycle until, loss of clinical benefit or unacceptable toxicity.
Independent Review Facility (IRF)-Assessed Progression-Free Survival (PFS)	6.18 months Interval 5.68 to 7.16	5.39 months Interval 4.4 to 5.52

PRIMARY outcome

Timeframe: From randomization to death from any cause (up to approximately 27 months)

Population: FAS included all randomized participants regardless of whether they received any study treatment.

OS was defined as the time from randomization to death from any cause.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab + PC n=229 Participants Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment.	Placebo + PC n=232 Participants Participants received atezolizumab matching placebo plus tiragolumab matching placebo in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e. atezolizumab matching placebo plus tiragolumab matching placebo on Day 1 of each 21-day cycle until, loss of clinical benefit or unacceptable toxicity.
Overall Survival (OS)	15.74 months Interval 13.31 to 20.44	11.10 months Interval 9.63 to 13.57

SECONDARY outcome

Timeframe: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 19 months)

Population: FAS included all randomized participants regardless of whether they received any study treatment.

PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause (whichever occurred first), as determined by the investigator 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). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab + PC n=229 Participants Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment.	Placebo + PC n=232 Participants Participants received atezolizumab matching placebo plus tiragolumab matching placebo in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e. atezolizumab matching placebo plus tiragolumab matching placebo on Day 1 of each 21-day cycle until, loss of clinical benefit or unacceptable toxicity.
Investigator-Assessed PFS	7.00 months Interval 6.08 to 7.52	5.45 months Interval 5.32 to 5.68

SECONDARY outcome

Timeframe: From randomization up to approximately 19 months

Population: FAS included all randomized participants regardless of whether they received any study treatment. Participants were classified as missing or not evaluable if no post-baseline response assessments were available or all post-baseline response assessments were not evaluable.

IRF- assessed confirmed ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) as determined by an IRF 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. OR=CR+PR

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab + PC n=226 Participants Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment.	Placebo + PC n=222 Participants Participants received atezolizumab matching placebo plus tiragolumab matching placebo in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e. atezolizumab matching placebo plus tiragolumab matching placebo on Day 1 of each 21-day cycle until, loss of clinical benefit or unacceptable toxicity.
IRF-Assessed Confirmed Objective Response Rate (ORR)	59.7 percentage of participants Interval 53.01 to 66.13	45.5 percentage of participants Interval 38.86 to 52.29

SECONDARY outcome

Timeframe: From randomization up to approximately 19 months

Population: FAS included all randomized participants regardless of whether they received any study treatment.

Investigator-assessed confirmed ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as 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. OR=CR+PR

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab + PC n=229 Participants Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment.	Placebo + PC n=232 Participants Participants received atezolizumab matching placebo plus tiragolumab matching placebo in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e. atezolizumab matching placebo plus tiragolumab matching placebo on Day 1 of each 21-day cycle until, loss of clinical benefit or unacceptable toxicity.
Investigator-Assessed Confirmed ORR	55.9 percentage of participants Interval 49.2 to 62.39	41.4 percentage of participants Interval 35.03 to 48.02

SECONDARY outcome

Timeframe: From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 19 months)

Population: FAS included all randomized participants regardless of whether they received any study treatment. DOR was assessed in participants who achieved a confirmed objective response, as determined by an IRF according to RECIST v1.1.

DOR was defined as the time from the first occurrence of a documented objective response (OR) to progressive disease (PD) or death from any cause (whichever occurred first) as determined by an IRF according to RECIST v1.1. OR=CR+PR. 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 on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab + PC n=135 Participants Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment.	Placebo + PC n=101 Participants Participants received atezolizumab matching placebo plus tiragolumab matching placebo in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e. atezolizumab matching placebo plus tiragolumab matching placebo on Day 1 of each 21-day cycle until, loss of clinical benefit or unacceptable toxicity.
IRF-Assessed Duration of Objective Response (DOR)	7.10 months Interval 6.28 to 9.46	4.34 months Interval 4.14 to 5.52

SECONDARY outcome

DOR was defined as the time from the first occurrence of a documented objective response (OR) to progressive disease (PD) or death from any cause (whichever occurred first) as determined by the investigator according to RECIST v1.1. OR=CR+PR. 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 on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab + PC n=128 Participants Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment.	Placebo + PC n=96 Participants Participants received atezolizumab matching placebo plus tiragolumab matching placebo in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e. atezolizumab matching placebo plus tiragolumab matching placebo on Day 1 of each 21-day cycle until, loss of clinical benefit or unacceptable toxicity.
Investigator-Assessed DOR	8.31 months Interval 6.97 to 12.48	5.78 months Interval 4.44 to 6.93

SECONDARY outcome

Timeframe: From randomization until the first confirmed clinically meaningful deterioration (up to approximately 27 months)

Population: FAS included all randomized participants regardless of whether they received any study treatment.

Clinically meaningful changes in physical functioning as measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30). EORTC QLQ-C30 is a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) within the previous week. Physical functioning was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning. Participants were considered "Worsened" if their baseline score decreased by \>/=10 points.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab + PC n=229 Participants Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment.	Placebo + PC n=232 Participants Participants received atezolizumab matching placebo plus tiragolumab matching placebo in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e. atezolizumab matching placebo plus tiragolumab matching placebo on Day 1 of each 21-day cycle until, loss of clinical benefit or unacceptable toxicity.
Time to Confirmed Deterioration (TTCD) in Participant-Reported Physical Functioning as Measured by EORTC QLQ-C30	16.10 months Interval 7.13 to NA = Not estimable due to insufficient number of events.	15.80 months Interval 7.95 to NA = Not estimable due to insufficient number of events.

SECONDARY outcome

Timeframe: From randomization until the first confirmed clinically meaningful deterioration (up to approximately 27 months)

Population: FAS included all randomized participants regardless of whether they received any study treatment.

Clinically meaningful changes in role functioning as measured by the EORTC QLQ-C30. EORTC QLQ-C30 is a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) within the previous week. Functioning items were scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning. Participants were considered "Worsened" if their baseline score decreased by \>/=10 points.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab + PC n=229 Participants Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment.	Placebo + PC n=232 Participants Participants received atezolizumab matching placebo plus tiragolumab matching placebo in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e. atezolizumab matching placebo plus tiragolumab matching placebo on Day 1 of each 21-day cycle until, loss of clinical benefit or unacceptable toxicity.
TTCD in Participant-Reported Role Functioning as Measured by EORTC QLQ-C30	15.11 months Interval 7.13 to NA = Not estimable due to insufficient number of events.	NA months Interval 15.31 to NA = Not estimable due to insufficient number of events.

SECONDARY outcome

Timeframe: From randomization until the first confirmed clinically meaningful deterioration (up to approximately 27 months)

Population: FAS included all randomized participants regardless of whether they received any study treatment.

Clinically meaningful changes in GHS/QoL as measured by the EORTC QLQ-C30. EORTC QLQ-C30 is a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) within the previous week. GHS and QoL items were scored on a 7-point scale: 1=Very poor, 2, 3, 4, 5, 6, 7=Excellent. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better GHS/QoL. Participants were considered "Worsened" if their baseline score decreased by \>/=10 points.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab + PC n=229 Participants Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment.	Placebo + PC n=232 Participants Participants received atezolizumab matching placebo plus tiragolumab matching placebo in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e. atezolizumab matching placebo plus tiragolumab matching placebo on Day 1 of each 21-day cycle until, loss of clinical benefit or unacceptable toxicity.
TTCD in Participant-Reported Global Health Status (GHS)/Quality of Life (QoL) as Measured by EORTC QLQ-C30	NA months Interval 18.07 to NA = Not estimable due to insufficient number of events.	18.20 months Interval 11.01 to NA = Not estimable due to insufficient number of events.

SECONDARY outcome

Timeframe: From randomization until the first confirmed clinically meaningful deterioration (up to approximately 35 months)

Population: FAS included all randomized participants regardless of whether they received any study treatment.

Clinically meaningful changes in dysphagia as measured by the EORTC QLQ-OES18. EORTC QLQ-OES18 is a modular supplement to the EORTC QLQ-C30 questionnaire for use in participants with esophageal cancer. EORTC QLQ-OES18 consisted of 4 multiple-item scale (dysphagia, eating, reflux, and pain) and 6 single items (trouble swallowing saliva, choked when swallowing, dry mouth, trouble with taste, trouble with coughing, and trouble talking) with a recall period of the previous week. Each symptom item was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher transformed scores (i.e. closer to 100) reflecting worse symptoms. Participants were considered "Worsened" if their baseline score increased by \>/=10 points.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab + PC n=229 Participants Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment.	Placebo + PC n=232 Participants Participants received atezolizumab matching placebo plus tiragolumab matching placebo in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e. atezolizumab matching placebo plus tiragolumab matching placebo on Day 1 of each 21-day cycle until, loss of clinical benefit or unacceptable toxicity.
TTCD in Participant-Reported Dysphagia as Measured by EORTC Quality of Life-Esophageal Cancer, Module 18 Questionnaire (EORTC QLQ-OES18)	NA months Interval 9.69 to NA = Not estimable due to insufficient number of events.	12.35 months Interval 7.0 to NA = Not estimable due to insufficient number of events.

SECONDARY outcome

Timeframe: Up to approximately 35 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose at on Day 1 of Cycles (cycle=21 days) 2, 3, 4, 8, 12, 16

As indicated in the row titles of the table Cmin of Cycle 1 was measured predose at Cycle (C) 2 Day (D) 1. Cmin of Cycle 2 was measured predose at C3D1, etc.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 (cycle=21 days), Day 1: 30 minutes postdose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose at on Day 1 of Cycles (cycle=21 days) 2, 3, 4, 8, 12, 16

As indicated in the row titles of the table Cmin of Cycle 1 was measured predose at Cycle (C) 2 Day (D) 1. Cmin of Cycle 2 was measured predose at C3D1, etc.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 (cycle=21 days), Day 1: 30 minutes postdose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose on Day 1 of Cycles (cycle=21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 35 months)

Participants were considered to be anti-drug antibody (ADA) positive if they were ADA negative or had missing data at Baseline but developed an ADA response following study drug exposure (i.e., treatment-induced ADA positive), or if they were ADA positive at baseline and the titer of one or more postbaseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (i.e., treatment-enhanced ADA positive); these ADA positive responses are summarized together (induced + enhanced) in the 'treatment-emergent ADA positive' category.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose on Day 1 of Cycles (cycle=21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 35 months)

Outcome measures

Outcome data not reported

Adverse Events

Placebo + PC

Serious events: 89 serious events

Other events: 223 other events

Deaths: 158 deaths

Atezolizumab + Tiragolumab + PC

Serious events: 94 serious events

Other events: 225 other events

Deaths: 129 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER