Balstilimab for Oropharyngeal Cancer

Overseen By Luana Guimaraes de Sousa, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Steroids, Glucocorticoids

Disqualifiers: Uncontrolled hypertension, Active infections, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Research Team

Luana Guimaraes de Sousa, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults over 18 with HPV+ oropharyngeal cancer confirmed by biopsy, who've completed treatment but still have detectable HPV. They must be in good health otherwise, with proper organ function and non-smokers or light smokers. Women of childbearing age must not be pregnant, breastfeeding, and agree to use contraception.

Inclusion Criteria

I still have HPV DNA in my blood after treatment, but no visible cancer.

My cancer is HPV positive or I've smoked less than 10 pack-years if HPV status is unknown.

I am a man who can father children and will use birth control during the study.

Exclusion Criteria

I am on systemic treatment for an autoimmune or rheumatological condition.

I have never been treated with anti-PD-1 or anti-PD-L1 therapies.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Definitive Therapy

Participants complete definitive therapy for HPV+ OPC

Not specified

Adjuvant Immune Therapy

Participants receive Balstilimab to evaluate viral clearance

Every 2 weeks

Visits on Days 1 and 15 of each cycle

Follow-up

Participants are monitored for safety, viral clearance, and long-term disease control

2 years

Treatment Details

Interventions

• Balstilimab

Trial Overview The study tests Balstilimab's ability to clear persistent HPV infection after standard cancer treatment in patients without visible disease. It aims to understand if clearing the virus can help control the cancer long-term.

Participant Groups

Group I: Balstilimab Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Agenus Inc.

Industry Sponsor

Trials

58

Recruited

4,900+