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    Clinical Trial Results:
    A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the 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)

    Summary
    EudraCT number
    		 2021-005712-62
    Trial protocol
    		 FR  
    Global end of trial date
    15 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Aug 2025
    First version publication date
    16 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CO43613
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05459129
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hoffmann-La Roche
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4058
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Aug 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Aug 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main purpose of this study was to evaluate the efficacy of treatment combinations consisting of Atezolizumab + Tiragolumab (Atezo+Tira), & Atezolizumab + Tiragolumab + carboplatin/paclitaxel (CP), in treatment-naive participants with locally advanced Stage III-IVA resectable squamous cell carcinoma of the head and neck (SCCHN).
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Apr 2023
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Israel: 2
    Country: Number of subjects enrolled
    Korea, Republic of: 3
    Country: Number of subjects enrolled
    United States: 7
    Worldwide total number of subjects
    12
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    7
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 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.

    Pre-assignment
    Screening details
    		 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.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Atezolizumab + Tiragolumab
    Arm description
    		 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.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tiragolumab
    Investigational medicinal product code
    RO7092284
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle.

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    RO5541267
    Other name
    Tecentriq
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle.

    Arm title
    		 Atezolizumab + Tiragolumab + CP
    Arm description
    		 Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of area under the concentration-time curve (AUC) 5 milligrams/milliliters/minutes (mg/mL/min) as IV infusion and paclitaxel, 175 milligrams/meter square (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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    RO5541267
    Other name
    Tecentriq
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle.

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin at a dose of AUC 5 mg/mL/min Q3W, as IV infusion on Day 1 of each 21-day cycle.

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    RO7092284
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel, 175 mg/m^2, as IV infusion on Day 1 of each 21-day cycle.

    Investigational medicinal product name
    Tiragolumab
    Investigational medicinal product code
    RO7092284
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle.

    Number of subjects in period 1
    		Atezolizumab + Tiragolumab Atezolizumab + Tiragolumab + CP
    Started
    6
    6
    Completed
    0
    0
    Not completed
    6
    6
         Study Terminated By Sponsor
    5
    6
         Death
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Atezolizumab + Tiragolumab
    Reporting group description
    		 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.

    Reporting group title
    Atezolizumab + Tiragolumab + CP
    Reporting group description
    		 Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of area under the concentration-time curve (AUC) 5 milligrams/milliliters/minutes (mg/mL/min) as IV infusion and paclitaxel, 175 milligrams/meter square (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.

    Reporting group values
    		 Atezolizumab + Tiragolumab Atezolizumab + Tiragolumab + CP Total
    Number of subjects
    		 6 6 12
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.83 ( 8.68 ) 52.33 ( 9.65 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 1 2 3
        Male
    		 5 4 9
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 4 0 4
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 2 6 8
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 1 1
        Not Hispanic or Latino
    		 6 5 11
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Atezolizumab + Tiragolumab
    Reporting group description
    		 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.

    Reporting group title
    Atezolizumab + Tiragolumab + CP
    Reporting group description
    		 Participants received atezolizumab, 1200 mg as IV infusion, along with tiragolumab, 600 mg, as IV infusion; carboplatin, at a dose of area under the concentration-time curve (AUC) 5 milligrams/milliliters/minutes (mg/mL/min) as IV infusion and paclitaxel, 175 milligrams/meter square (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.

    Primary: Percentage of Participants With Pathologic Complete Response (pCR) as Determined by Local Pathologic Review

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    End point title
    		 Percentage of Participants With Pathologic Complete Response (pCR) as Determined by Local Pathologic Review
    End point description
    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. Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.
    End point type
    Primary
    End point timeframe
    At the time of surgery (Week 7 ± 1 week)
    End point values
    		 Atezolizumab + Tiragolumab Atezolizumab + Tiragolumab + CP
    Number of subjects analysed
    6
    6
    Units: percentage of participants
        number (confidence interval 95%)
    16.7 (0.42 to 64.12)
    50.0 (11.81 to 88.19)
    Statistical analysis title
    		 Atezo+Tira vs Atezo+Tira+ CP
    Comparison groups
    Atezolizumab + Tiragolumab v Atezolizumab + Tiragolumab + CP
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in pCR Rates
    Point estimate
    33.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.23
         upper limit
    		 99.9

    Secondary: Pathologic Response Rate (pRR) as Determined by Local Pathologic Review

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    End point title
    		 Pathologic Response Rate (pRR) as Determined by Local Pathologic Review
    End point description
    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. Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.
    End point type
    Secondary
    End point timeframe
    At the time of surgery (Week 7 ± 1 week)
    End point values
    		 Atezolizumab + Tiragolumab Atezolizumab + Tiragolumab + CP
    Number of subjects analysed
    6
    6
    Units: percentage of participants
        number (confidence interval 95%)
    66.7 (22.28 to 95.67)
    100 (54.07 to 100.00)
    Statistical analysis title
    		 Atezo+Tira vs Atezo+Tira+ CP
    Comparison groups
    Atezolizumab + Tiragolumab v Atezolizumab + Tiragolumab + CP
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in pRR
    Point estimate
    33.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.05
         upper limit
    		 87.72

    Secondary: Event-Free Survival (EFS)

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    End point title
    		 Event-Free Survival (EFS)
    End point description
    EFS=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/distant disease recurrence/death from any cause, whichever occurs first. PD=at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline), & must also demonstrate an absolute increase of ≥ 5 millimeters (mm). Kaplan-Meier method was used to estimate the median for EFS, & 95% Cls was constructed using Brookmeyer & Crowley method. Efficacy-evaluable population. 9999=Median & upper limit of 95 % CI was not estimable due to insufficient number of participants with events. 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.
    End point type
    Secondary
    End point timeframe
    From randomization to PD disease recurrence or death (Up to 9.2 months)
    End point values
    		 Atezolizumab + Tiragolumab Atezolizumab + Tiragolumab + CP
    Number of subjects analysed
    6 [1]
    6 [2]
    Units: months
        median (confidence interval 95%)
    9999 (2.96 to 9999)
    9999 (4.30 to 9999)
    Notes
    [1] - Median & 95% CI couldn't be estimated due to insufficient events as study was terminated prematurely
    [2] - Median & 95% CI couldn't be estimated due to insufficient events as study was terminated prematurely
    Statistical analysis title
    		 Atezo+Tira vs Atezo+Tira+ CP
    Statistical analysis description
    HR was estimated by Cox regression. 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.
    Comparison groups
    Atezolizumab + Tiragolumab v Atezolizumab + Tiragolumab + CP
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.11
         upper limit
    		 3.91

    Secondary: Relapse-Free Survival (RFS)

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    End point title
    		 Relapse-Free Survival (RFS)
    End point description
    RFS=time from surgery to first documented recurrence of disease/death from any cause. Recurrent disease= 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 regional nodal basin; distant recurrence as any non-local/non-regional recurrence. Kaplan-Meier method was used to estimate the median for RFS, and 95% Cls was constructed using Brookmeyer and Crowley method. Adjuvant-evaluable population included all participants who received at least 1 dose of each drug and who completed surgery. 9999= Median and upper limit of 95 % CI was not estimable due to insufficient number of participants with events. Due to early termination of 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
    End point type
    Secondary
    End point timeframe
    From surgery (scheduled at Week 7 ± 1 week) to first documented disease recurrence or death (up to 7.6 months)
    End point values
    		 Atezolizumab + Tiragolumab Atezolizumab + Tiragolumab + CP
    Number of subjects analysed
    5
    6
    Units: months
        median (confidence interval 95%)
    9999 (0.99 to 9999)
    9999 (2.79 to 9999)
    Statistical analysis title
    		 Atezo+Tira vs Atezo+Tira+ CP
    Statistical analysis description
    HR was estimated by Cox regression. 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 media RFS per arm or HR between the arms.
    Comparison groups
    Atezolizumab + Tiragolumab v Atezolizumab + Tiragolumab + CP
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 6.43

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    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. Efficacy-evaluable population included all who received at least one dose of each drug for their assigned treatment regimen. 9999=median and upper limit of 95 % CI was not estimable due to insufficient number of participants with events. 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.
    End point type
    Secondary
    End point timeframe
    From randomization to death from any cause or last known to be alive (Up to 9.2 months)
    End point values
    		 Atezolizumab + Tiragolumab Atezolizumab + Tiragolumab + CP
    Number of subjects analysed
    6
    6
    Units: months
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    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. Percentages have been rounded off to the nearest whole number.
    End point type
    Secondary
    End point timeframe
    Prior to surgery (up to Week 6)
    End point values
    		 Atezolizumab + Tiragolumab Atezolizumab + Tiragolumab + CP
    Number of subjects analysed
    6
    6
    Units: percentage of participants
        number (confidence interval 95%)
    33.3 (4.33 to 77.72)
    50.0 (11.81 to 88.19)
    Statistical analysis title
    		 Atezo+Tira vs Atezo+Tira+ CP
    Comparison groups
    Atezolizumab + Tiragolumab + CP v Atezolizumab + Tiragolumab
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in ORR
    Point estimate
    16.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -54.99
         upper limit
    		 88.32

    Secondary: Landmark EFS Rate

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    End point title
    		 Landmark EFS Rate
    End point description
    EFS=time from randomization to PD that precludes surgery,as determined by investigator per RECIST v1.1; local, regional, or distant disease recurrence/death from any cause, whichever occurs first. EFS rate=percentage of participants who are event-free at the specified timepoints. PD=at least a 20% increase in SOD of target lesions, taking as reference smallest SOD at prior timepoints (including baseline) & must also demonstrate an absolute increase of ≥ 5 mm. EFS rates were estimated for each study arm using the Kaplan-Meier method, with 95% CIs calculated using Greenwood's formula. Efficacy-evaluable population. 'n' 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. 999=No participants were analyzed for this timepoint. Due to early termination of study, limited sample size & follow-up time no meaningful conclusions were made.
    End point type
    Secondary
    End point timeframe
    3 Months, 6 Months, and 1 Year
    End point values
    		 Atezolizumab + Tiragolumab Atezolizumab + Tiragolumab + CP
    Number of subjects analysed
    6
    6
    Units: percentage of participants
    number (confidence interval 95%)
        3 Months (n=4, 5)
    66.67 (28.95 to 100.00)
    83.33 (53.51 to 100.00)
        6 Months (n=4, 4)
    66.67 (28.95 to 100.00)
    66.67 (28.95 to 100.00)
        1 Year (n=0, 0)
    999 (999 to 999)
    999 (999 to 999)
    Statistical analysis title
    		 Atezo+Tira vs Atezo+Tira+ CP (6 Months)
    Statistical analysis description
    Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made.
    Comparison groups
    Atezolizumab + Tiragolumab v Atezolizumab + Tiragolumab + CP
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in Event Free Rate
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -53.34
         upper limit
    		 53.34
    Statistical analysis title
    		 Atezo+Tira vs Atezo+Tira+ CP (3Months)
    Statistical analysis description
    Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made.
    Comparison groups
    Atezolizumab + Tiragolumab v Atezolizumab + Tiragolumab + CP
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in Event Free Rate
    Point estimate
    16.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.42
         upper limit
    		 64.75

    Secondary: Landmark RFS Rate

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    End point title
    		 Landmark RFS Rate
    End point description
    RFS=time from surgery to the first documented recurrence of disease/death from any cause. RFS rate=percentage of participants who are event-free at specified timepoints. Recurrent disease=local, regional, or distant recurrence: local recurrence= tumor regrowth within 2 cm of the primary lesion's tumor bed; regional recurrence= any nodal/non-nodal tumor lesions > 2 cm from primary lesion but are not beyond the regional nodal basin; distant recurrence= any non-local/non-regional recurrence. RFS rates were estimated using KM method, with 95% CIs calculated using Greenwood's formula. Adjuvant-evaluable population. ‘n’ 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.999=No participants were analyzed for this timepoint. Due to early termination of study, limited sample size & follow-up time no meaningful conclusions were made.
    End point type
    Secondary
    End point timeframe
    3 Months, 6 Months, and 1 Year
    End point values
    		 Atezolizumab + Tiragolumab Atezolizumab + Tiragolumab + CP
    Number of subjects analysed
    5
    6
    Units: percentage of participants
    number (confidence interval 95%)
        3 Months (n=4, 4)
    80.00 (44.94 to 100.00)
    66.67 (28.95 to 100.00)
        6 Months (n=2, 2)
    60.00 (17.06 to 100.00)
    66.67 (28.95 to 100.00)
        1 Year (n=0, 0)
    999 (999 to 999)
    999 (999 to 999)
    Statistical analysis title
    		 Atezo+Tira vs Atezo+Tira+ CP (6 Months)
    Statistical analysis description
    Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made .
    Comparison groups
    Atezolizumab + Tiragolumab v Atezolizumab + Tiragolumab + CP
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in Event Free Rate
    Point estimate
    6.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -50.49
         upper limit
    		 63.82
    Statistical analysis title
    		 Atezo+Tira vs Atezo+Tira+ CP (3 Months)
    Statistical analysis description
    Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made .
    Comparison groups
    Atezolizumab + Tiragolumab v Atezolizumab + Tiragolumab + CP
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in Event Free Rate
    Point estimate
    -13.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -64.83
         upper limit
    		 38.16

    Secondary: Landmark OS Rate

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    End point title
    		 Landmark OS Rate
    End point description
    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. Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. 'n' 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. 999=No participants were analyzed for this timepoint. Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made .
    End point type
    Secondary
    End point timeframe
    3 Months, 6 Months, and 1 Year
    End point values
    		 Atezolizumab + Tiragolumab Atezolizumab + Tiragolumab + CP
    Number of subjects analysed
    6
    6
    Units: percentage of participants
    number (confidence interval 95%)
        3 Months (n=6, 6)
    100.00 (100.00 to 100.00)
    100.00 (100.00 to 100.00)
        6 Months (n=5, 6)
    83.33 (53.51 to 100.00)
    100.00 (100.00 to 100.00)
        1 Year (n= 0,0)
    999 (999 to 999)
    999 (999 to 999)
    No statistical analyses for this end point

    Secondary: Number of Participants With Adverse Events (AEs)

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    End point title
    		 Number of Participants With Adverse Events (AEs)
    End point description
    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. Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.
    End point type
    Secondary
    End point timeframe
    From initiation of study treatment up to 135 days after the final dose of study treatment (up to 5.1 months)
    End point values
    		 Atezolizumab + Tiragolumab Atezolizumab + Tiragolumab + CP
    Number of subjects analysed
    6
    6
    Units: participants
    6
    6
    No statistical analyses for this end point

    Secondary: Number of Participants with Immune-Related AEs Grade >=3

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    End point title
    		 Number of Participants with Immune-Related AEs Grade >=3
    End point description
    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. Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.
    End point type
    Secondary
    End point timeframe
    Up to 12 weeks
    End point values
    		 Atezolizumab + Tiragolumab Atezolizumab + Tiragolumab + CP
    Number of subjects analysed
    6
    6
    Units: participants
    0
    0
    No statistical analyses for this end point

    Secondary: Rate of Delayed Surgery Due to Treatment-Related AEs

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    End point title
    		 Rate of Delayed Surgery Due to Treatment-Related AEs
    End point description
    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. Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.
    End point type
    Secondary
    End point timeframe
    Delay after the planned time of surgery (scheduled at Week 7 ± 1 week) up to 2 weeks (up to Week 9)
    End point values
    		 Atezolizumab + Tiragolumab Atezolizumab + Tiragolumab + CP
    Number of subjects analysed
    6
    6
    Units: participants
    0
    0
    No statistical analyses for this end point

    Secondary: Duration of Delayed Surgery Due to Treatment-Related AEs

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    End point title
    		 Duration of Delayed Surgery Due to Treatment-Related AEs
    End point description
    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. Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment. Number analyzed= participants with delayed surgery due to treatment related AEs.
    End point type
    Secondary
    End point timeframe
    Delay after the planned time of surgery (scheduled at Week 7 ± 1 week) up to 2 weeks (up to Week 9)
    End point values
    		 Atezolizumab + Tiragolumab Atezolizumab + Tiragolumab + CP
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: weeks
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [3] - No participants had surgery delayed due to treatment-related AEs.
    [4] - No participants had surgery delayed due to treatment-related AEs.
    No statistical analyses for this end point

    Secondary: Rate of Surgical Complications as Assessed According to the Clavien-Dindo Surgical Classification

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    End point title
    		 Rate of Surgical Complications as Assessed According to the Clavien-Dindo Surgical Classification
    End point description
    Surgical complications were scored according to Clavien-Dindo surgical classification. Complication rates for every grade were scored for participants who underwent complete lymph node dissection (CLND). Surgical complications per Clavien-Dindo are classified into following grades: Grade I=Any complication not needing pharmacological treatment/surgical, endoscopic & radiological interventions. Grade II=Complications requiring pharmacological treatment with drugs/blood transfusions & total parenteral nutrition. Grade III=Complications that require surgical, endoscopic/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 death of participant. Only non-zero categorical data was reported. Number analyzed=number of participants who underwent surgery.
    End point type
    Secondary
    End point timeframe
    From Surgery (Week 7 ± 1 week) up to 5.1 months
    End point values
    		 Atezolizumab + Tiragolumab Atezolizumab + Tiragolumab + CP
    Number of subjects analysed
    5
    6
    Units: percentage of participants
        Grade IIIb
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    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
    Adverse event reporting additional description
    Safety-evaluable population included all randomized participants who received any amount of dose of any component of the study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Atezolizumab + Tiragolumab + CP
    Reporting group description
    		 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.

    Reporting group title
    Atezolizumab + Tiragolumab
    Reporting group description
    		 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.

    Serious adverse events
    		 Atezolizumab + Tiragolumab + CP Atezolizumab + Tiragolumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 6 (50.00%)
    1 / 6 (16.67%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Arterial injury
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Vascular rupture
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Atezolizumab + Tiragolumab + CP Atezolizumab + Tiragolumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    6 / 6 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Peritumoural oedema
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    2 / 6 (33.33%)
    1 / 6 (16.67%)
         occurrences all number
    4
    2
    Influenza like illness
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Localised oedema
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Pyrexia
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    Pain
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Oedema
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Productive cough
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Anxiety
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Sleep disorder
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Radiation skin injury
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Procedural pain
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    2
    Wound dehiscence
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Paraesthesia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Dysgeusia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Swelling of eyelid
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Mouth swelling
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Mouth haemorrhage
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Hypoaesthesia oral
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Dysphagia
         subjects affected / exposed
    2 / 6 (33.33%)
    1 / 6 (16.67%)
         occurrences all number
    2
    1
    Dyspepsia
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Dry mouth
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Constipation
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    Tongue ulceration
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Oral pain
         subjects affected / exposed
    3 / 6 (50.00%)
    1 / 6 (16.67%)
         occurrences all number
    3
    2
    Nausea
         subjects affected / exposed
    4 / 6 (66.67%)
    2 / 6 (33.33%)
         occurrences all number
    7
    2
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Rash
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Pruritus
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Alopecia
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Dermatitis
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Spondylolisthesis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Arthralgia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Infections and infestations
    Otitis externa
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Enterobacter infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Candida infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Appendicitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Hypercalcaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Hyponatraemia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Dec 2022
    • Treatment arms Atezolizumab monotherapy arm and Atezolizumab +Tira + immune-modulating stereotactic body radiotherapy (iSBRT) arm were removed. • EU Clinical Trials (CT) number was added to align with Clinical Trials Regulation and other guidelines • The landmark event-free survival, landmark relapse-free survival, and landmark overall survival were considered part of secondary efficacy endpoints instead of exploratory efficacy endpoints according to study design. Exploratory efficacy endpoints section was removed. • The total number of participants to enroll in the study was adapted to the removal of Atezo monotherapy and Atezo +Tira + iSBRT arms. • HIV inclusion criteria were modified to include more eligible population • Additional minor changes were made to improve clarity and consistency

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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