Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0)
NCT07513324 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116
Last updated 2026-04-07
Summary
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,.
Conditions
- HPV-positive Oropharyngeal Squamous Cell Carcinoma
- Oropharyngeal Squamous Cell Carcinoma
Interventions
- DRUG
-
Pembroluzimab
monoclonal antibody, single-dose vial via intravenous (through the arm) infusion, per protocol
- OTHER
-
Observation
Standard of care observation
Sponsors & Collaborators
- collaborator INDUSTRY
- lead OTHER
Principal Investigators
-
Glenn Hanna, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-01
- Primary Completion
- 2028-01-01
- Completion
- 2030-01-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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