BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients (NCT05363709) | Clinical Trial Compass
Active — Not RecruitingPhase 2
BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients
United States20 participantsStarted 2023-10-18
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
✓. Histologically or cytologically confirmed squamous cell carcinoma from oropharynx. note: patients with a clinical diagnosis of oropharyngeal cancer, awaiting a biopsy is eligible to consent for prescreening.
✓. Stage I-III per AJCC 8th edition
✓. Positive p16 immunohistochemistry or HPV testing, or p16/HPV status unknown with patients having a less than 10 pack-year smoking history
✓. Age ≥ 18 years at the time of consent.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 for patients who receive treatment
✓. Persistent detection of cfDNA HPV (≥ 16 copies/mL) in the absence of clinically evident disease at 3, 6, or 9 months following definitive treatment (surgery, systemic therapy, and/or radiation therapy).
✓. Patients must have adequate hematologic, coagulation, hepatic, and renal function for anti-PD1 treatment. this includes:
Exclusion criteria
✕. Prior treatment history with anti-PD-1 or anti-PD-L1 therapies are not allowed.
✕. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol, or active and uncontrolled infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
What they're measuring
1
To establish the Overall survival.
Timeframe: through study completion, an average of 2 years
✕. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirement.
✕. Active rheumatological or autoimmune conditions requiring systemic treatment, such as steroids.
✕. Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or noninfectious pneumonitis requiring high-dose glucocorticoids.