NCT05363709
Active, not recruiting
Phase 2
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
M.D. Anderson Cancer Center1 site in 1 country20 target enrollmentStarted: October 18, 2023Last updated:
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- To establish the Overall survival.
Overview
Brief 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.
Detailed Description
Objectives:
Primary Objective:
To assess whether anti-PD1 will lead to the clearance of the virus in the plasma cfDNA in HPV+ OPC patients with persistent cfDNA HPV following definitive therapy
Secondary Objectives:
- One-year recurrence-free survival (1-yr RFS),
- 2-year RFS (2-yr RFS),
- Overall survival (2-yr OS),
- Safety and tolerability
- Compliance
- Quality of life (EORTC C30 will be utilized)
Correlative/Exploratory Objectives:
- Time to viral clearance in the oral rinse and plasma cfDNA with anti-PD1 treatment
- The concordance between plasma HPV and oral rinse HPV at diagnosis, post-definitive treatment and during adjuvant treatment
- The correlation between tumor mutations and persistence of HPV in oral rinse/cfDNA.
- The correlation between recurrence site (loco-regional vs. distant metastasis) and oral rinse vs. plasma HPV detection
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject must meet all of the following applicable inclusion criteria to participate in this study:
- •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:
- •ANC \>/= 1,500/mm3
Exclusion Criteria
- •Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- •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).
- •Screening for chronic conditions is not required.
- •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.
Arms & Interventions
Balstilimab
Experimental
Participants will receive Balstilimab by vein over about 30 minutes on Days 1 and 15 of each cycle (every 2 weeks)
Intervention: Balstilimab (Drug)
Outcomes
Primary Outcomes
To establish the Overall survival.
Time Frame: through study completion, an average of 2 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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