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Virus Therapy

HB-202/HB-201 for Head and Neck Cancer

Phase 2

Recruiting

Led By Winston Wong, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of histologically confirmed HPV16+ squamous cell cancer is required

No clinical or radiographic evidence of persistent or recurrent disease at time of evaluation

Must not have

Patients with simultaneous primary cancers aside from HPV 16+ HNSCC

Known acquired immunodeficiency syndrome due to untreated/poorly controlled human immunodeficiency virus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Summary

"This trial is testing if HB-202/HB-201 can effectively treat HPV 16-positive head and neck cancer that has shown up in the blood after standard treatment. Participants should currently show no signs

Who is the study for?

This trial is for individuals with HPV 16-positive head and neck cancer who've completed standard treatment but have signs of potential microscopic cancer as indicated by a positive NavDx blood test. They should show no visible signs of cancer on scans or physical exams.

What is being tested?

The study tests HB-202/HB-201 to see if it's effective in treating HPV 16+ HNSCC after standard treatments, using the investigational NavDx test to detect possible remaining cancer at the microscopic level.

What are the potential side effects?

Specific side effects are not listed, but generally, clinical trials may involve risks like allergic reactions, fatigue, nausea, and other drug-specific adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is HPV16+ squamous cell type, confirmed by tests.

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I currently show no signs of cancer returning or persisting.

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I agree to use birth control.

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I am fully active or can carry out light work.

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My cancer is HPV16+ and located in the head or neck, treated with standard therapy.

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I have undergone treatment with the goal of completely curing my disease.

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I am not pregnant, not breastfeeding, and follow the required contraceptive guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have HPV 16+ head and neck cancer and no other primary cancers.

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I have AIDS due to untreated or poorly controlled HIV.

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I am on long-term antiviral medication.

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I am on immunosuppressive therapy for an autoimmune or inflammatory disorder.

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My cancer is a recurring or spreading squamous cell carcinoma in the head or neck.

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I have had chemotherapy or immunotherapy for incurable head and neck cancer.

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I am pregnant, breastfeeding, or planning to become pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease free survival (DFS)

Secondary study objectives

Number of participants with adverse events (type, frequency, severity).

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: HB-200 armExperimental Treatment1 Intervention

HB-202 and HB-201 will be given in an alternating fashion as per above for a full one-year duration unless there is clinical or radiographic evident and/or pathologically confirmed recurrence.

Group II: PlaceboPlacebo Group1 Intervention

Placebo will be given via IV administration on Day 1 of each cycle on the same schedule as HB-200 treatment for a full one-year duration unless there is evidence of radiographic recurrence.

0 / 14Eligibility criteria met