Trial Outcomes & Findings for A Study Evaluating Efficacy and Safety of Multiple Treatment Combinations in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (Morpheus-Head and Neck Cancer) (NCT NCT05459129)

Last Updated: 2025-09-15

Results Overview

pCR was defined as the absence of any viable primary tumor at time of surgical resection, as determined by local pathologic review. The pCR rate was defined as the percentage of participants who achieved a pCR. pCR rate was calculated for each arm, along with the 95% confidence interval (CI) estimated using the Clopper-Pearson method and the 95% CI for difference in rates was estimated using the Wald method with continuity correction. Participants with missing or no pathologic response assessment were classified as non-responders. Percentages have been rounded off to the nearest whole number.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

At the time of surgery (Week 7 ± 1 week)

Results posted on

2025-09-15

Participant Flow

A total of 12 participants with locally advanced squamous cell carcinoma of the head and neck (SCCHN) took part in the study across 6 investigative sites in Israel, the Republic of Korea, and the United States from 12 April 2023 to 15 Aug 2024.

Participants were randomized to receive either Atezolizumab + Tiragolumab or Atezolizumab + Tiragolumab + carboplatin/ paclitaxel (CP). At the discretion of the investigator, participants started adjuvant therapy outside of this study, commencing between Week 10 and Week 13 and after treatment completion/discontinuation visit.

Participant milestones

Participant milestones
Measure	Atezolizumab + Tiragolumab Participants received atezolizumab, 1200 milligrams (mg) as intravenous (IV) infusion, along with tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.	Atezolizumab + Tiragolumab + CP Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of AUC 5 mg/mL/min as IV infusion and paclitaxel, 175 mg/m\^2, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
Overall Study STARTED	6	6
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Atezolizumab + Tiragolumab Participants received atezolizumab, 1200 milligrams (mg) as intravenous (IV) infusion, along with tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.	Atezolizumab + Tiragolumab + CP Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of AUC 5 mg/mL/min as IV infusion and paclitaxel, 175 mg/m\^2, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
Overall Study Death	1	0
Overall Study Study Terminated By Sponsor	5	6

Baseline Characteristics

A Study Evaluating Efficacy and Safety of Multiple Treatment Combinations in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (Morpheus-Head and Neck Cancer)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atezolizumab + Tiragolumab n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.	Atezolizumab + Tiragolumab + CP n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of AUC 5 mg/mL/min as IV infusion and paclitaxel, 175 mg/m\^2, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.	Total n=12 Participants Total of all reporting groups
Age, Continuous	67.83 years STANDARD_DEVIATION 8.68 • n=5 Participants	52.33 years STANDARD_DEVIATION 9.65 • n=7 Participants	60.08 years STANDARD_DEVIATION 11.92 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At the time of surgery (Week 7 ± 1 week)

Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.	Atezolizumab + Tiragolumab + CP n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of AUC 5 mg/mL/min as IV infusion and paclitaxel, 175 mg/m\^2, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
Percentage of Participants With Pathologic Complete Response (pCR) as Determined by Local Pathologic Review	16.7 percentage of participants Interval 0.42 to 64.12	50.0 percentage of participants Interval 11.81 to 88.19

SECONDARY outcome

Timeframe: At the time of surgery (Week 7 ± 1 week)

Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.

pRR was defined as the percentage of participants with a pCR, major pathological response (mPR), and pathological partial response (pPR). pCR was defined as the absence of any viable primary tumor at time of surgical resection, as determined by local pathologic review. mPR was defined as ≤10% residual viable tumor at the time of surgical resection in the primary tumor. pPR was defined as ≤ 50% residual viable tumor at the time of surgical resection in the primary tumor. pRR was calculated for each arm, along with the 95% CI, estimated using the Clopper-Pearson method, and the 95% CI for the difference in rates was estimated using the Wald method with continuity correction. Percentages have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.	Atezolizumab + Tiragolumab + CP n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of AUC 5 mg/mL/min as IV infusion and paclitaxel, 175 mg/m\^2, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
Pathologic Response Rate (pRR) as Determined by Local Pathologic Review	66.7 percentage of participants Interval 22.28 to 95.67	100 percentage of participants Interval 54.07 to 100.0

SECONDARY outcome

Timeframe: From randomization to PD disease recurrence or death (Up to 9.2 months)

Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.

EFS was defined as the time from randomization to disease progression (PD) that precludes surgery, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); local, regional, or distant disease recurrence or death from any cause, whichever occurs first. PD was defined as 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), and must also demonstrate an absolute increase of ≥ 5 millimeters (mm). Kaplan-Meier method was used to estimate the median for EFS, and 95% Cls was constructed using Brookmeyer and Crowley method. Data from participants who have not experienced such events were censored at the time of the last tumor assessment. Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made in terms of median EFS per arm or HR between the arms.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.	Atezolizumab + Tiragolumab + CP n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of AUC 5 mg/mL/min as IV infusion and paclitaxel, 175 mg/m\^2, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
Event-Free Survival (EFS)	NA months Interval 2.96 to Median and upper and lower limits of 95% CI could not be estimated due to insufficient events as the study was terminated prematurely	NA months Interval 4.3 to Median and upper and lower limits of 95% CI could not be estimated due to insufficient events as the study was terminated prematurely

SECONDARY outcome

Timeframe: From surgery (scheduled at Week 7 ± 1 week) to first documented disease recurrence or death (up to 7.6 months)

Population: Adjuvant-evaluable population included all participants who received at least one dose of each drug and who completed surgery.

RFS was defined as the time from surgery to the first documented recurrence of disease or death from any cause. Recurrent disease included local, regional, or distant recurrence: local recurrence was defined as tumor regrowth within 2 centimeter (cm) of the primary lesion's tumor bed; regional recurrence as any nodal or non-nodal tumor lesions that are more than 2 cm from the primary lesion but are not beyond the regional nodal basin; distant recurrence as any non-local/non-regional recurrence. Participants who did not have documented recurrence of disease or died, RFS was censored at the day of the last tumor assessment. Kaplan-Meier method was used to estimate the median for RFS, and 95% Cls was constructed using Brookmeyer and Crowley method. Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made in terms of median RFS per arm or HR between the arms.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab n=5 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.	Atezolizumab + Tiragolumab + CP n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of AUC 5 mg/mL/min as IV infusion and paclitaxel, 175 mg/m\^2, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
Relapse-Free Survival (RFS)	NA months Interval 0.99 to Median and upper limit of 95 % CI was not estimable due to insufficient number of participants with events.	NA months Interval 2.79 to Median and upper limit of 95 % CI was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From randomization to death from any cause or last known to be alive (Up to 9.2 months)

Population: Efficacy-evaluable population included all who received at least one dose of each drug for their assigned treatment regimen.

OS was defined as the time from randomization to death from any cause. Data from participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. Kaplan-Meier method was used to estimate the median for OS, and 95% Cls was constructed using Brookmeyer and Crowley method. Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made in terms of median OS and no further OS analysis are reported.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.	Atezolizumab + Tiragolumab + CP n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of AUC 5 mg/mL/min as IV infusion and paclitaxel, 175 mg/m\^2, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
Overall Survival (OS)	NA months Median and 95 % CI was not estimable due to insufficient number of participants with events.	NA months Median and 95 % CI was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Prior to surgery (up to Week 6)

Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.

ORR was defined as the percentage of participants with an objective tumor response of complete response (CR) or partial response (PR) as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. ORR was calculated for each arm, along with 95% CIs, using the Clopper-Pearson method and the 95% CI for difference in rates was estimated using the Wald method with continuity correction. Participants with missing or no response assessments were classified as non-responders.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.	Atezolizumab + Tiragolumab + CP n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of AUC 5 mg/mL/min as IV infusion and paclitaxel, 175 mg/m\^2, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
Objective Response Rate (ORR)	33.3 percentage of participants Interval 4.33 to 77.72	50.0 percentage of participants Interval 11.81 to 88.19

SECONDARY outcome

Timeframe: 3 Months, 6 Months, and 1 Year

Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. Number analyzed per timepoint are unique number of participants out of all the assessed participants who remain at risk for an EFS event at that timepoint. Different participants may have contributed data for each timepoint.

EFS was defined as the time from randomization to PD that precludes surgery, as determined by the investigator according to RECIST v1.1; local, regional, or distant disease recurrence or death from any cause, whichever occurs first. EFS rate was defined as the percentage of participants who are event-free at the specified timepoints. PD was defined as 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), and must also demonstrate an absolute increase of ≥ 5 mm. Landmark EFS rates were estimated for each study arm using the Kaplan-Meier method, with 95% CIs calculated through the use of Greenwood's formula. Percentages have been rounded off to the nearest whole number. Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.	Atezolizumab + Tiragolumab + CP n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of AUC 5 mg/mL/min as IV infusion and paclitaxel, 175 mg/m\^2, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
Landmark EFS Rate 3 Months	66.67 percentage of participants Interval 28.95 to 100.0	83.33 percentage of participants Interval 53.51 to 100.0
Landmark EFS Rate 6 Months	66.67 percentage of participants Interval 28.95 to 100.0	66.67 percentage of participants Interval 28.95 to 100.0

SECONDARY outcome

Timeframe: 3 Months, 6 Months, and 1 Year

Population: Adjuvant-evaluable population included all participants who received at least one dose of each drug and who completed surgery. Number analyzed per timepoint are unique number of participants out of all the assessed participants who remain at risk for an RFS event at that timepoint. Different participants may have contributed data for each timepoint.

RFS was defined as the time from surgery to the first documented recurrence of disease or death from any cause. RFS rate was defined as the percentage of participants who are event-free at the specified timepoints. Recurrent disease included local, regional, or distant recurrence: local recurrence was defined as tumor regrowth within 2 cm of the primary lesion's tumor bed; regional recurrence as any nodal or non-nodal tumor lesions that are more than 2 cm from the primary lesion but are not beyond the regional nodal basin; distant recurrence as any non-local/non-regional recurrence. Landmark RFS rates were estimated for each study arm using the Kaplan-Meier method, with 95% CIs calculated through the use of Greenwood's formula. Percentages have been rounded off to the nearest whole number. Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made .

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab n=5 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.	Atezolizumab + Tiragolumab + CP n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of AUC 5 mg/mL/min as IV infusion and paclitaxel, 175 mg/m\^2, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
Landmark RFS Rate 3 Months	80.00 percentage of participants Interval 44.94 to 100.0	66.67 percentage of participants Interval 28.95 to 100.0
Landmark RFS Rate 6 Months	60.00 percentage of participants Interval 17.06 to 100.0	66.67 percentage of participants Interval 28.95 to 100.0

SECONDARY outcome

Timeframe: 3 Months, 6 Months, and 1 Year

Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. Number analyzed per timepoint are unique number of participants out of all the assessed participants who remain at risk for an OS event at that timepoint. Different participants may have contributed data for each timepoint.

OS was defined as the time from randomization to death from any cause. OS rate was defined as the percentage of participants who are event-free at the specified timepoints. Landmark OS rates were estimated for each study arm using the Kaplan-Meier method, with 95% CIs calculated through the use of Greenwood's formula. Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made .

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.	Atezolizumab + Tiragolumab + CP n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of AUC 5 mg/mL/min as IV infusion and paclitaxel, 175 mg/m\^2, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
Landmark OS Rate 3 Months	100.00 percentage of participants Interval 100.0 to 100.0	100.00 percentage of participants Interval 100.0 to 100.0
Landmark OS Rate 6 Months	83.33 percentage of participants Interval 53.51 to 100.0	100.00 percentage of participants Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: From initiation of study treatment up to 135 days after the final dose of study treatment (up to 5.1 months)

Population: Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.	Atezolizumab + Tiragolumab + CP n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of AUC 5 mg/mL/min as IV infusion and paclitaxel, 175 mg/m\^2, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
Number of Participants With Adverse Events (AEs)	6 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.

An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Grade 3 AEs were defined as severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.	Atezolizumab + Tiragolumab + CP n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of AUC 5 mg/mL/min as IV infusion and paclitaxel, 175 mg/m\^2, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
Number of Participants With Immune-Related AEs Grade >=3	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Delay up to week after the planned time of surgery (scheduled at Week 7 ± 1 week) up to 2 weeks (up to Week 9)

Population: Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment. Percentages have been rounded off.

Rate of delayed surgery due to treatment related AEs was defined as the percentage of participants for whom surgery was delayed due to treatment-related AEs for 2 weeks. An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.	Atezolizumab + Tiragolumab + CP n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of AUC 5 mg/mL/min as IV infusion and paclitaxel, 175 mg/m\^2, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
Rate of Delayed Surgery Due to Treatment-Related AEs	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Delay up to week after the planned time of surgery (scheduled at Week 7 ± 1 week) up to 2 weeks (up to Week 9)

Population: Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment. No participants had surgery delayed due to treatment-related AEs.

Duration of surgery delay due to treatment related AEs was calculated on the participants for whom surgery was delayed due to treatment-related AEs for 2 weeks. An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Surgery (Week 7 ± 1 week) up to 5.1 months

Population: Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment. Overall number analyzed is the number of participants who underwent surgery. Percentages have been rounded off.

Surgical complications were scored according to Clavien-Dindo surgical classification. Complication rates for every grade were reported \& scored for participants who underwent complete lymph node dissection (CLND). The Surgical complications according to Clavien-Dindo can be classified into following grades: Grade I: Any complication that does not need pharmacological treatment or surgical, endoscopic, and radiological interventions. Grade II: Complications that require pharmacological treatment with drugs or blood transfusions and total parenteral nutrition. Grade III: Complications that require surgical, endoscopic, or radiological intervention with (Grade IIIb) or without (Grade IIIa) general anesthesia. Grade IV: Life-threatening complications requiring intensive care unit (ICU) management, which may be single organ (Grade IVa) or multiorgan (Grade IVb) dysfunction. Grade V: Complications that might cause the death of a participant. Only categories with non-zero data was reported.

Outcome measures

Outcome measures
Measure	Atezolizumab + Tiragolumab n=5 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.	Atezolizumab + Tiragolumab + CP n=6 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of AUC 5 mg/mL/min as IV infusion and paclitaxel, 175 mg/m\^2, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
Rate of Surgical Complications as Assessed According to the Clavien-Dindo Surgical Classification	0 percentage of participants	16.7 percentage of participants

Adverse Events

Atezolizumab + Tiragolumab

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Atezolizumab + Tiragolumab + CP

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Atezolizumab + Tiragolumab n=6 participants at risk Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.	Atezolizumab + Tiragolumab + CP n=6 participants at risk Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of AUC 5 mg/mL/min as IV infusion and paclitaxel, 175 mg/m\^2, as IV infusion on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7 ± 1 week) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • From initiation of study treatment up to 135 after the final dose of study treatment (up to 5.1 months) All-cause mortality: Up to 9.2 months Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.	16.7% 1/6 • Number of events 1 • From initiation of study treatment up to 135 after the final dose of study treatment (up to 5.1 months) All-cause mortality: Up to 9.2 months Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.
Infections and infestations Appendicitis	16.7% 1/6 • Number of events 1 • From initiation of study treatment up to 135 after the final dose of study treatment (up to 5.1 months) All-cause mortality: Up to 9.2 months Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.	0.00% 0/6 • From initiation of study treatment up to 135 after the final dose of study treatment (up to 5.1 months) All-cause mortality: Up to 9.2 months Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.
Infections and infestations Pneumonia aspiration	0.00% 0/6 • From initiation of study treatment up to 135 after the final dose of study treatment (up to 5.1 months) All-cause mortality: Up to 9.2 months Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.	16.7% 1/6 • Number of events 1 • From initiation of study treatment up to 135 after the final dose of study treatment (up to 5.1 months) All-cause mortality: Up to 9.2 months Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.
Infections and infestations Pneumonia bacterial	0.00% 0/6 • From initiation of study treatment up to 135 after the final dose of study treatment (up to 5.1 months) All-cause mortality: Up to 9.2 months Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.	16.7% 1/6 • Number of events 1 • From initiation of study treatment up to 135 after the final dose of study treatment (up to 5.1 months) All-cause mortality: Up to 9.2 months Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.
Infections and infestations Sepsis	16.7% 1/6 • Number of events 1 • From initiation of study treatment up to 135 after the final dose of study treatment (up to 5.1 months) All-cause mortality: Up to 9.2 months Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.	0.00% 0/6 • From initiation of study treatment up to 135 after the final dose of study treatment (up to 5.1 months) All-cause mortality: Up to 9.2 months Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.
Injury, poisoning and procedural complications Arterial injury	16.7% 1/6 • Number of events 1 • From initiation of study treatment up to 135 after the final dose of study treatment (up to 5.1 months) All-cause mortality: Up to 9.2 months Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.	0.00% 0/6 • From initiation of study treatment up to 135 after the final dose of study treatment (up to 5.1 months) All-cause mortality: Up to 9.2 months Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/6 • From initiation of study treatment up to 135 after the final dose of study treatment (up to 5.1 months) All-cause mortality: Up to 9.2 months Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.	16.7% 1/6 • Number of events 2 • From initiation of study treatment up to 135 after the final dose of study treatment (up to 5.1 months) All-cause mortality: Up to 9.2 months Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/6 • From initiation of study treatment up to 135 after the final dose of study treatment (up to 5.1 months) All-cause mortality: Up to 9.2 months Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.	16.7% 1/6 • Number of events 1 • From initiation of study treatment up to 135 after the final dose of study treatment (up to 5.1 months) All-cause mortality: Up to 9.2 months Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.
Vascular disorders Vascular rupture	16.7% 1/6 • Number of events 1 • From initiation of study treatment up to 135 after the final dose of study treatment (up to 5.1 months) All-cause mortality: Up to 9.2 months Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.	0.00% 0/6 • From initiation of study treatment up to 135 after the final dose of study treatment (up to 5.1 months) All-cause mortality: Up to 9.2 months Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.

Other adverse events

Additional Information

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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.
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