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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT07513324
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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,.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Jan 1, 2028
Completion
Jan 1, 2030

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Adjuvant Pembroluzimab
    * Cycle 1 through Cycle 9 (42-day cycles) * Days 1-378: Predetermined dose of Pembrolizumab once every 6 weeks, up to 9 cycles * Follow up for up to 2 years
  • Active Comparator: Observation
    Cycle 1 through Cycle 9 (42-day cycles) Days 1-378: Standard of care observation Device: NavDx® TTMV-HPV DNA testing (used for risk stratification and treatment assignment) Follow up for up to 2 years

Primary Outcome Measure

Progression-free Survival at 2 Years (PFS2) [ Time Frame: 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02215
Glenn Hanna, MD
[email protected]
617-632-3779
Glenn Hanna, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Glenn Hanna, MD
[email protected]
617-632-3779
Glenn Hanna, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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