OncoMatch/Clinical Trials/NCT05363709
BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients
Is NCT05363709 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Balstilimab for hpv.
Treatment: Balstilimab — This study aims to leverage this unique property of HPV+ OPC to detect possible minimal residual disease represented by persistent viral detection after the completion of definitive treatment. The study will offer adjuvant immune therapy to patients with persistent viral detection and evaluate the clearance of viral load. It will evaluate the rate of viral clearance with immune therapy and establish the link between viral clearance and long-term disease control.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HPV cfDNA HPV ≥ 16 copies/mL (≥ 16 copies/mL)
Persistent detection of cfDNA HPV (≥ 16 copies/mL) in the absence of clinically evident disease at 3, 6, or 9 months following definitive treatment
Allowed: CDKN2A overexpression
Positive p16 immunohistochemistry or HPV testing, or p16/HPV status unknown with patients having a less than 10 pack-year smoking history
Allowed: HPV positive
Positive p16 immunohistochemistry or HPV testing, or p16/HPV status unknown with patients having a less than 10 pack-year smoking history
Disease stage
Required: Stage I, II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: definitive treatment — surgery, systemic therapy, and/or radiation therapy
following definitive treatment (surgery, systemic therapy, and/or radiation therapy)
Cannot have received: anti-PD-1 therapy
Prior treatment history with anti-PD-1 or anti-PD-L1 therapies are not allowed.
Cannot have received: anti-PD-L1 therapy
Prior treatment history with anti-PD-1 or anti-PD-L1 therapies are not allowed.
Lab requirements
Blood counts
ANC ≥ 1,500/mm3; platelet count ≥100,000/mm3; HgB ≥ 9 g/dL (may be with transfusion)
Kidney function
Creatinine ≤ 1.5x ULN or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute
Liver function
Total Serum Bilirubin ≤ 1.5 x ULN (Patients with known Gilbert Syndrome, a total bilirubin ≤ 3.0 x ULN, with direct bilirubin ≤ 1.5 x ULN); SGOT, SGPT ≤ 3 X ULN; SGOT, SGPT ≤ 5 X ULN
Patients must have adequate hematologic, coagulation, hepatic, and renal function for anti-PD1 treatment. this includes: ANC ≥ 1,500/mm3; platelet count ≥100,000/mm3; HgB ≥ 9 g/dL (may be with transfusion); Creatinine ≤ 1.5x ULN or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute; Total Serum Bilirubin ≤ 1.5 x ULN (Patients with known Gilbert Syndrome, a total bilirubin ≤ 3.0 x ULN, with direct bilirubin ≤ 1.5 x ULN); SGOT, SGPT ≤ 3 X ULN; SGOT, SGPT ≤ 5 X ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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