PhIIIRandom VolrustomigSeqThe VsObservPa w/UnrescLocaAdvH&NTBSquamCellCarcinNotProgFollwConcurrChemo
Study Description
Arm A - Volrustomig: Participants in the volrustomig arm will receive 750 mg IV on
Day 1 of each 21-day cycle for up to 12 months or 18 cycles, or until RECIST 1.1‑defined
radiological PD confirmed by investigator assessment, unless there is evidence of
unacceptable toxicity, or if a participant requests to stop the study intervention (for
discontinuation of study intervention/observation criteria, see Section 7.1). Approximately
573 participants will be treated with volrustomig 750 mg IV Q3W in this study
Arm B - Observation: Participants in the observation arm will undergo observation for up
to 12 months or until RECIST 1.1-defined radiological PD confirmed by investigator
assessment, or any study discontinuation criterion is met (for study discontinuation
criteria, see Section 7.1). Approximately 573 participants will be observed during this
study.
Eligibility
- Participants will have completed standard-of-care definitive cCRT with curative intent
within 12 weeks (84 days) prior to randomization as presented below. If baseline CT/MRI
images are equivocal and/or residual disease is suspected, investigators are strongly
recommended to perform an FDG-PET assessment to confirm absence of progression.
Where FDG-PET-avid lesions are detected and accessible, an endoscopy is recommended
to be performed and a biopsy taken as clinically indicated to confirm residual disease and
evaluate whether participation in this study is appropriate.
- Participants must not have progressed following definitive cCRT therapy with curative
intent. Absence of recurrence and/or progression will be assessed by the following
imaging procedures up to 12 weeks after the last dose of cCRT.
- Local disease (primary tumor site and neck) will be assessed by CT (preferred) or
MRI with contrast from mid-orbits to thoracic inlet.
- Absence of disease outside of the head and neck will be assessed by CT with contrast
(preferred) of the chest, abdomen including liver, and pelvis as clinically indicated or
by MRI if CT with IV contrast is contraindicated.
- Confirmation of PD-L1 expression from tumor tissue sample per Inclusion Criterion 4
(all participants) by the central laboratory. Participants with unknown PD-L1 expression
prior to randomization are not eligible for the study
- Adequate organ and bone marrow function (in the absence of transfusions or growth
factor support within 14 days prior to Screening Part II).
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