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Virus Therapy

HB-200 arm for Cervical 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease free survival (DFS)

Secondary outcome measures

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

NaverisUNKNOWN

2 Previous Clinical Trials

175 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,846 Total Patients Enrolled

Hookipa Biotech GmbHIndustry Sponsor

5 Previous Clinical Trials

417 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new patients currently being accepted for enrollment in this medical study?

"As indicated on clinicaltrials.gov, patient recruitment is ongoing for this current trial. The initial posting date was 4/15/2024 with the most recent update also dated as 4/15/2024."

Answered by AI

What is the current number of individuals undergoing treatment within this clinical trial?

"Yes, information on clinicaltrials.gov shows that this specific study is currently in search of suitable participants. Initially shared on April 15th, 2024 and most recently revised on the same date, the trial aims to enroll a total of 51 individuals distributed across seven different sites."

Answered by AI

How numerous are the locations conducting this medical investigation within our city?

"The ongoing trial is operational at 7 diverse locations, including but not limited to New york, Middletown, and Montvale. Opting for a site in close proximity can help reduce the burden of travel when taking part in this study."

Answered by AI