Dana-Farber Cancer Institute
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,.
This is a phase 2 randomized, open-label clinical trial to evaluate 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 for participants with stage I, II, or III, HPV-associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma,. Participants will be randomized 2:1 into one of two study arms: Arm 1 Pembroluzimab vs. Arm 2 Observation. Randomization is stratified by NavDx detectability at 6 weeks post curative intent therapy: yes/no. The U.S…
Inclusion Criteria: * 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 elig…
monoclonal antibody, single-dose vial via intravenous (through the arm) infusion, per protocol
Standard of care observation
Arctuva estimate
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