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Experimental vaccines show promise against HPV-Driven cancers

NCT ID NCT04180215

Disease control Sponsor: Hookipa Biotech GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed phase I/II trial tested two experimental vaccines, HB-201 and HB-202, in 198 people with HPV 16+ cancers. The goal was to find a safe dose and see if the vaccines could shrink tumors. Participants received the vaccines alone or with standard treatments like pembrolizumab. The study focused on safety and early signs of effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HB-201 and HB-202 (therapeutic vaccines targeting HPV 16+ cancers)
What this could lead to
If successful, this could lead to a new treatment option for HPV 16+ cancers, potentially shrinking tumors or slowing disease progression.
What could go wrong
This is an early-phase trial (phase I/II), so results may not confirm effectiveness. Side effects or lack of tumor response are possible, and the approach may not work for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

198 people

The number who actually took part.

Started

Dec 2019

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria All Patients: * Documentation of confirmed HPV 16+ cancer via genotype testing. * ≥ 1 measurable lesion by imaging for tumor response following RECIST * ECOG performance status of 0 to 1. * Prior curative radiation therapy and prior focal palliative completed per protocol-specified wash-out windows. * Screening laboratory values must meet protocol-specified criteria. * Able to provide tumor tissue following last treatment, unless otherwise agreed. Treatment Group E or Group F: * Documentation of confirmed head and neck squamous cell carcinoma. * Eligible to receive pembrolizumab, per standard of care and product label. * Group E: this group includes first line / 1L patients who have not yet received treatment in the metastatic/recurrent setting. * Group F: Tumor progression or recurrence on standard of care therapy, including ≥1 systemic therapy. Imaging Sub-Study (for specific participants at Memorial Sloan Kettering Cancer Center only): * Meeting requirements of inclusion criteria for Treatment Group 1 or Group 3. * At least 1 non-irradiated measurable lesion documented through imaging. Exclusion Criteria: All patients: * Metastatic central nervous system disease, and/or carcinomatous meningitis. * Any serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with study participation / treatment administration. * Concurrent malignancy that is clinically significant or requires active intervention, unless protocol-defined criteria are met. * Active, known or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy. * Has a life expectancy of less than 3 months. * Any toxicities attributed to systemic prior anticancer therapy o that have not resolved to Grade 1 or baseline prior to the first administration of study drug, unless protocol-defined criteria is met. * Not meeting the protocol-specified washout periods for prohibited medications. * Prior anaphylactic reaction to or known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s). * Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, indicating acute or chronic infection. * Known history of acquired immunodeficiency syndrome. For patients in Groups E or F and certain backfill cohorts: * History of severe hypersensitivity reaction to or other contraindication to receiving pembrolizumab. * History of/Presently having non-infectious pneumonitis requiring treatment. * Was discontinued due to a Grade 3 or higher immune-related AE (irAE) after receiving prior therapy with check point inhibitors. Imaging Sub-Study (for specific participants at Memorial Sloan Kettering Cancer Center only): * Having splenic disorders or prior splenectomy, and can compromise protocol objectives per Investigator and/or Sponsor. * Meeting requirements of exclusion criteria for Treatment Group 3

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Conditions

The condition(s) this trial relates to.

carcinoma Head and Neck Neoplasms head and neck squamous cell carcinoma human papillomavirus-related squamous cell carcinoma oropharynx cancer squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck squamous cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HPV-related squamous cell carcinoma

Contacts and locations

Locations

  • Amsterdam UMC, Locatie VUMC

    Amsterdam, 1081, Netherlands

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050, Spain

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Froedtert Hospital and Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Greenville Hospital System University Medical Center (ITOR)

    Greenville, South Carolina, 29605, United States

  • Grossman School of Medicine

    New York, New York, 10016, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 410009, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041, Spain

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Loyola University Medical School

    Maywood, Illinois, 60153, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021, United States

  • Montefiore-Einstein Center for Cancer Care

    The Bronx, New York, 10461, United States

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114, United States

  • O'Neal Comprehensive Cancer Center at UAB

    Birmingham, Alabama, 35294, United States

  • Perlmutter Cancer Center at NYU Langone Hospital-Long Island

    New York, New York, 11501, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903, United States

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UCLA (University of California, Los Angeles)

    Los Angeles, California, 90095, United States

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • University of Arkansas for Medical Sciences, Cancer Institute, Clinical Trials Office

    Fayetteville, Arkansas, 72205, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center

    Fairway, Kansas, 66205, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Virgina Health System

    Charlottesville, Virginia, 22908, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.