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Viral Therapy + Pembrolizumab for Head and Neck Cancer
Study Summary
This trial is testing a new cancer treatment that uses two different viruses to attack HPV-16+ cancers. It is open to people with HPV-16+ confirmed cancers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I stopped my previous cancer treatment due to a severe immune system side effect.I have been diagnosed with AIDS.I have at least one tumor that can be measured on scans.I have an autoimmune or inflammatory disorder that needs treatment to suppress my immune system.I am assigned to either Treatment Group E or F.I am approved to receive pembrolizumab treatment.I have or had lung inflammation not caused by infection that needed treatment.You had a strong allergic reaction to pembrolizumab or have a medical condition that makes it unsafe for you to receive pembrolizumab.You have had a severe allergic reaction to the study drug or any of its ingredients.I have been diagnosed with head and neck squamous cell carcinoma.I have not received any treatment for my cancer since it became metastatic or recurred.I can provide a sample of my tumor tissue after my last treatment.I've completed radiation therapy aimed at curing my cancer and any palliative treatment as required.My cancer has spread to my brain or its coverings.I am fully active or can carry out light work.I have had my spleen removed or have spleen issues that might affect the study.My cancer is confirmed to be HPV 16 positive.I do not have another cancer that needs treatment right now.My side effects from previous cancer treatments have mostly gone away.My cancer has worsened or returned after standard treatment, including at least one systemic therapy.
- Group 1: Ph I, Group 1 and Group 2
- Group 2: Ph I, Group 3 and Group 4
- Group 3: Ph I, sub-study
- Group 4: Ph II, Group F
- Group 5: Ph II, Group B
- Group 6: Ph II, Group E
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any other scientific experiments that have explored the effects of HB-201 intravenous administration combined with pembrolizumab and a typical treatment plan?
"HB-201 intravenous administration + standard of care, which was initially explored at City of Hope in 2010, has now seen 249 experiments. Furthermore, Fairway, Kansas currently hosts a significant number (961) of live trials related to this study."
What positive results are anticipated through this experiment?
"The primary outcome of this clinical trial, measured from the start of dosing until up to 28 days afterwards, is assessing participants' preliminary antitumor activity based on objective response rate and disease control rate. Alongside that, secondary objectives are determining the safety and tolerability levels through monitoring adverse events (type, frequency, severity), verifying preliminary antitumor activity using RECIST/iRECIST metrics for ORR/DCR evaluation, as well as confirming duration of such responses with overall survival & progression-free survival measurements."
How many people are partaking in this clinical experiment?
"In order to execute the study, Hookipa Biotech GmbH requires a cohort of 200 individuals who meet the clinical trial's criteria. The research will be conducted through University of Kansas Medical Center in Fairway, Kansas and Loyola University Medical School in Maywood, Illinois among other locations."
Are there multiple sites in Canada that are currently running this clinical experiment?
"This medical research is taking place at the University of Kansas Medical Centre in Fairway, Loyola University Medical School in Maywood and the University of Iowa Hospitals & Clinics situated in Iowa City. In addition to these 3 sites, 18 more locations are participating across the US."
What maladies has the HB-201 intravenous administration + standard of care regimen including pembrolizumab been applied to?
"For the treatment of malignant neoplasms, unresectable melanoma and microsatellite instability high conditions, HB-201 intravenous administration in tandem with a pembrolizumab-based standard of care regimen has proven to be effective."
Is participation in this research study still available to qualified individuals?
"Affirmative. According to the clinicaltrials.gov website, this research endeavour is still open for participants. It started on December 11th 2019 and was most recently updated on November 16th 2022. Two-hundred individuals must be recruited from 18 different locations."
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