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Virus Therapy

Viral Therapy + Pembrolizumab for Head and Neck Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Hookipa Biotech GmbH

Eligibility Criteria Checklist

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

Must have

Treatment Group E or Group F:

Eligible to receive pembrolizumab, per standard of care and product label.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30-months (until progression)

Awards & highlights

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.

Who is the study for?

This trial is for patients with HPV16+ recurrent or metastatic head and neck squamous cell carcinoma and other cancers. Participants must have an ECOG performance status of 0 to 1, at least one measurable lesion, meet specific lab value criteria, and be eligible for pembrolizumab treatment. They cannot join if they have autoimmune disorders requiring immunosuppression, a life expectancy under three months, certain infections like hepatitis B/C or AIDS, severe allergies to the drugs used in the study or prior severe reactions to similar treatments.Check my eligibility

What is being tested?

The trial tests HB-201 alone or alternating with HB-202 intravenous therapies in combination with pembrolizumab against standard care regimens including pembrolizumab. It's a Phase I/II study that includes dose escalation (finding the right drug amount) and expansion (testing it on more people). Some participants may also use a CD8 PET Tracer for imaging studies.See study design

What are the potential side effects?

Potential side effects include immune system reactions leading to inflammation in various organs, infusion-related responses such as fever or chills during administration of therapy, fatigue from treatment burden on the body's resources, digestive issues due to medication affecting gastrointestinal function, blood disorders stemming from bone marrow suppression by chemotherapy agents.

Eligibility Criteria

Inclusion Criteria

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

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I am assigned to either Treatment Group E or F.

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I am approved to receive pembrolizumab treatment.

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I have been diagnosed with head and neck squamous cell carcinoma.

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I have not received any treatment for my cancer since it became metastatic or recurred.

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I am fully active or can carry out light work.

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My cancer is confirmed to be HPV 16 positive.

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My cancer has worsened or returned after standard treatment, including at least one systemic therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30-months (until progression)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30-months (until progression)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30-months (until progression) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Phase I Dose Escalation: Determine Phase II dose based on incidence of dose-limiting toxicities.

Phase II Dose Expansion: Number of participants with preliminary antitumor activity based on objective response rate.

Secondary outcome measures

Phase I Dose Escalation: Number of participants with adverse events (type, frequency, severity).

Phase I Dose Escalation: Number of participants with preliminary antitumor activity based on objective response rate and disease control rate.

Phase II Dose Expansion: Number of participants with adverse events (type, frequency, severity).

+1 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Ph II, Group FExperimental Treatment1 Intervention

Patients with HPV 16+ cancers who had tumor progression or recurrence on standard of care therapy and who are eligible to receive pembrolizumab as part of 2L+ standard of care..

Group II: Ph II, Group EExperimental Treatment1 Intervention

Patients with HPV 16+ HNSCC who are eligible to receive pembrolizumab as part of 1L standard of care.

Group III: Ph II, Group BExperimental Treatment1 Intervention

Patients with HPV 16+ HNSCC who are eligible to receive immune checkpoint inhibitor as part of standard of care.

Group IV: Ph I, sub-studyExperimental Treatment1 Intervention

Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy

Group V: Ph I, Group 3 and Group 4Experimental Treatment1 Intervention

Patients with HPV 16+ HNSCC or Non-HNSCC who had tumor progression or recurrence on standard of care therapy.

Group VI: Ph I, Group 1 and Group 2Experimental Treatment1 Intervention

Patients with HPV 16+ HNSCC or Non-HNSCC who had tumor progression or recurrence on standard of care therapy.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hookipa Biotech GmbHLead Sponsor

5 Previous Clinical Trials

268 Total Patients Enrolled

Chief Medical OfficerStudy DirectorHookipa Biotech GmbH

122 Previous Clinical Trials

21,324 Total Patients Enrolled

Media Library

HB-201 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04180215 — Phase 1 & 2

Squamous Cell Carcinoma Research Study Groups: Ph I, Group 1 and Group 2, Ph I, Group 3 and Group 4, Ph I, sub-study, Ph II, Group F, Ph II, Group B, Ph II, Group E

Squamous Cell Carcinoma Clinical Trial 2023: HB-201 Highlights & Side Effects. Trial Name: NCT04180215 — Phase 1 & 2

HB-201 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04180215 — Phase 1 & 2

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers

2019. "A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04180215.

All > Squamous Cell Carcinoma