OncoMatch/Clinical Trials/NCT06589609
Phase 1 Clinical Trial of FluBHPVE6E7 Immunotherapy for HPV16-Associated Oropharyngeal Cancer
Is NCT06589609 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies FluBHPVE6E7 for oropharyngeal squamous cell carcinoma (scc).
Treatment: FluBHPVE6E7 — A clinical study of an immunotherapy in patients with head or neck cancers associated with the HPV16 virus
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A overexpression
p16- and HPV16-positive oropharyngeal squamous cell carcinoma
Required: HPV16 positive
p16- and HPV16-positive oropharyngeal squamous cell carcinoma
Disease stage
Required: Stage T2N2-3, M0, T3N0-3, M0, T4N0-3, M0
Performance status
KARNOFSKY 70–100
Demographics
Prior therapy
Cannot have received: major surgery
Prior major surgery within 4 weeks before day 0
Cannot have received: investigational drug
Participation in another experimental protocol/use of investigational drug within two months before day 0
Lab requirements
Blood counts
Clinically significant out of range haematological laboratory tests which cannot be explained by the underlying disease [excluded]
Kidney function
Clinically significant out of range renal laboratory tests which cannot be explained by the underlying disease [excluded]
Liver function
Clinically significant out of range hepatic laboratory tests which cannot be explained by the underlying disease [excluded]
Cardiac function
Normal screening ECG or screening ECG with no clinically significant findings requiring immediate treatment, as judged by the investigator
Clinically significant out of range haematological, renal or hepatic laboratory tests which cannot be explained by the underlying disease; Normal screening ECG or screening ECG with no clinically significant findings requiring immediate treatment, as judged by the investigator
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06589609 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CDKN2A?
Yes, CDKN2A overexpression is a required biomarker for enrollment.
Does this trial require HPV16?
Yes, HPV16 positive is a required biomarker for enrollment.
What disease stage is eligible?
Stage T2N2-3, M0 or T3N0-3, M0 or T4N0-3, M0 is required.
Is there an age limit?
Yes. Patients must be 65 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages