NCT07513324

Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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,.

Detailed description

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. Food and Drug Administration (FDA) has not approved NavDx® as a method for guiding treatment decision-making for human papillomavirus (HPV)-driven oropharyngeal cancers. The U.S. Food and Drug Administration (FDA) has approved pembrolizumab as a treatment option for human papillomavirus (HPV)-driven oropharyngeal cancers. The research study procedures include screening for eligibility, in-clinic visits, urine tests, questionnaires, tumor assessment by one or more of the following standard assessment tools: X-ray, CT (Computerized Tomography) scan, MRI (Magnetic Resonance Imaging) or PET (Positron Emission Tomography) scans, blood tests (including NavDx TTMV-HPV DNA Testing), biobanking, Electrocardiogram (ECG), and tumor tissue biopsy. It is expected that about 116 people will take part in this research study.

Conditions

• HPV-positive Oropharyngeal Squamous Cell Carcinoma
• Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pembroluzimab	monoclonal antibody, single-dose vial via intravenous (through the arm) infusion, per protocol
OTHER	Observation	Standard of care observation

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-01-01
• Completion: 2030-01-01
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study