The purpose of this study is to assess risk for HPV driven oropharyngeal cancers by using HPV blood tests and clinical features (such as tumor stage and smoking status) to determine appropriate treatment to improve survival outcomes in participants with stage I, II, or III, HPV-associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma,.
Participants must have histologically or cytologically confirmed, stage I, II, or III, HPV-associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma, as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition staging. Participants with HPV-associated disease of unknown primary (cT0) are eligible.
Participants who undergo upfront surgery are permitted to enroll if their post-operative pathology necessitates that they receive adjuvant therapy.
Participants who undergo upfront induction chemotherapy with platinum-based therapy are eligible if they have less than a complete clinical or radiologic response to induction as judged by the treating investigator(s).
Participants with locoregionally recurrent disease are eligible if they completed definitive or curative-intent treatment and meet criteria 3.1, 6e below.
Participants with AJCC 2017 8th edition stage IV (M1, metastatic) disease.
Pregnant or lactating women.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or another stimulatory or co-inhibitory T-cell receptor treatment.
Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Parallel
Pembroluzimab
Drugmonoclonal antibody, single-dose vial via intravenous (through the arm) infusion, per protocol
Observation
Other interventionStandard of care observation
Progression-free Survival at 2 Years (PFS2)
PFS2 is the percent probability estimate at 2 years based on the Kaplan-Meier method. PFS is defined as the time from the date of randomization to first invasive local, regional, distant progression, invasive second head and neck primary, or death due to any cause. Participants alive without progression are censored at date of last disease evaluation. Progression should be confirmed by biopsy or lymph node removal when feasible, but may also be determined based on clinical or pathologic evidence at the discretion of the treating investigator.
Grade 3 or 4 Adverse Event (AE) Rate
Grade 3 or 4 AE rate is defined as the proportion of participants who experience grade 3 or 4 adverse events during study treatment. AEs are summarized and graded based on CTCAE 5.0.
Median Progression-free Survival (PFS)
PFS is defined as the time from the date of randomization to first invasive local, regional, distant progression, invasive second head and neck primary, or death due to any cause. Participants alive without progression are censored at date of last disease evaluation. Progression should be confirmed by biopsy or lymph node removal when feasible, but may also be determined based on clinical or pathologic evidence at the discretion of the treating investigator.
Median Overall Survival (OS)
OS based on Kaplan-Meier method is defined as the time from randomization to death due to any cause or censored at date last known alive.
Median Distant Metastatic-free Survival (DMFS)
DMFS based on Kaplan-Meier method is defined as the time from randomization to the earlier of the first occurrence of distant or metastatic disease, or death due to any cause. Confirmation of distant metastasis should be obtained via pathologic evaluation (biopsy or lymph node removal) when feasible, by imaging evidence (CT, MRI, or PET-CT) using RECIST-style lesion measurement criteria, or by clinical judgment if pathologic or imaging confirmation is not possible. Progression limited to the primary site or regional lymph nodes is not considered an event for DMFS. Suspicion of distant metastasis based solely on indeterminate or positive PET-CT findings should be confirmed with continued clinical follow-up or pathologically.Participants alive without distant or metastatic recurrence are censored at date of last disease evaluation.
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Dana-Farber Cancer Institute
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
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