RecruitingPhase 2NCT05363709

BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients

A Phase 2 Study to Assess the Effect of BALSTILIMAB (AGEN2034) on Viral Clearance in HPV-positive Oropharyngeal Cancer Patients With Persistent HPV Detection in Plasma cfDNA After Definitive Therapy

Sponsor

M.D. Anderson Cancer Center

Enrollment

20 participants

Start Date

Oct 18, 2023

Study Type

INTERVENTIONAL

Conditions

Oropharyngeal Cancer HPV

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an immunotherapy drug called balstilimab can help the immune system clear the HPV virus from people with HPV-positive oropharyngeal cancer (throat cancer caused by HPV), potentially improving treatment outcomes. **You may be eligible if...** - You have squamous cell carcinoma of the oropharynx (throat/tonsil area) confirmed by biopsy - Your tumor tests positive for HPV (p16 positive) - Your cancer is stage I–III and being treated with curative intent - You have not received prior treatment for this cancer **You may NOT be eligible if...** - You have active autoimmune disease requiring systemic treatment - You have had prior immunotherapy - You are pregnant or breastfeeding - You have significant heart, lung, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBalstilimab

Given by Vein (IV)

Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05363709

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