BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients

NCT05363709 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2021-1077NCI-2022-03805
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV; Oropharyngeal Cancer

Outcome Measures

Primary Outcomes (1)

• To establish the Overall survival.

  through study completion, an average of 2 years

Study Arms (1)

Balstilimab

EXPERIMENTAL

Participants will receive Balstilimab by vein over about 30 minutes on Days 1 and 15 of each cycle (every 2 weeks)

Drug: Balstilimab

Interventions

Balstilimab DRUG

Given by Vein (IV)

Also known as: Balstilimab IB

Balstilimab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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 (that is, if serum creatinine is \>1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed).
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Agenus Inc.: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Interventions

balstilimab

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Luana Guimaraes de Sousa, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 6, 2022
• Study Start: October 18, 2023
• Primary Completion (Estimated): February 15, 2028
• Study Completion (Estimated): February 15, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)