A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers
NCT ID: NCT04180215
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
198 participants
INTERVENTIONAL
2019-12-11
2025-01-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
TheraT® Vectors (Vaccines) Combined With Chemotherapy to Treat HPV16 Head and Neck Cancers
NCT05108870
A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC)
NCT06373380
A Study of HB-202/HB-201 With Pembrolizumab in Patients With HPV16+ Recurrent/Metastatic Oropharyngeal Cancer
NCT06513884
Safety and Efficacy of VB10.16 and Pembrolizumab in Patients with Head-Neck Squamous Cell Carcinoma
NCT06016920
HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cell Carcinoma
NCT04369937
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The trial is enrolling patients with metastatic/recurrent head and neck cancer who have not yet received treatment in this setting (1L, first line) and who are eligible to receive pembrolizumab as part of their standard of care. This trial is also enrolling patients with metastatic/recurrent head and neck who have received prior treatment in this setting (2L+, second and later line) who are eligible to receive pembrolizumab as part of their standard of care. Patients will receive the study drugs in addition to their pembrolizumab standard of care regimen.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ph I, Group 1 and Group 2
Patients with HPV 16+ HNSCC or Non-HNSCC who had tumor progression or recurrence on standard of care therapy.
HB-201 intravenous administration.
Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).
Ph I, Group 3 and Group 4
Patients with HPV 16+ HNSCC or Non-HNSCC who had tumor progression or recurrence on standard of care therapy.
HB-202 intravenous administration alternating with HB-201 intravenous administration.
Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).
Ph II, Group B
Patients with HPV 16+ HNSCC who are eligible to receive immune checkpoint inhibitor as part of standard of care.
HB-201 intravenous administration + standard of care regimen including pembrolizumab.
Dose Expansion
Ph II, Group E
Patients with HPV 16+ HNSCC who are eligible to receive pembrolizumab as part of 1L standard of care.
HB-202 / HB-201 alternating intravenous administration + standard of care regimen including pembrolizumab.
Dose Expansion
Ph II, Group F
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..
HB-202 / HB-201 alternating intravenous administration + pembrolizumab.
Dose Expansion
Ph I, sub-study
Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy
HB-201 or HB-201/HB-202 alternating treatment using CD8 PET Tracer (Zr-Df-IAB22M2C)
Dose escalation; 10 patients
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HB-201 intravenous administration.
Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).
HB-202 intravenous administration alternating with HB-201 intravenous administration.
Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).
HB-201 intravenous administration + standard of care regimen including pembrolizumab.
Dose Expansion
HB-202 / HB-201 alternating intravenous administration + pembrolizumab.
Dose Expansion
HB-202 / HB-201 alternating intravenous administration + standard of care regimen including pembrolizumab.
Dose Expansion
HB-201 or HB-201/HB-202 alternating treatment using CD8 PET Tracer (Zr-Df-IAB22M2C)
Dose escalation; 10 patients
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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):
* At least 1 non-irradiated measurable lesion documented through imaging.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hookipa Biotech GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Head of Clinical Development
Role: STUDY_DIRECTOR
Hookipa Biotech GmbH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
O'Neal Comprehensive Cancer Center at UAB
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
University of Arkansas for Medical Sciences, Cancer Institute, Clinical Trials Office
Fayetteville, Arkansas, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA (University of California, Los Angeles)
Los Angeles, California, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Loyola University Medical School
Maywood, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Fairway, Kansas, United States
Henry Ford Hospital
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Grossman School of Medicine
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital-Long Island
New York, New York, United States
Montefiore-Einstein Center for Cancer Care
The Bronx, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Providence Portland Medical Center
Portland, Oregon, United States
Greenville Hospital System University Medical Center (ITOR)
Greenville, South Carolina, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Virgina Health System
Charlottesville, Virginia, United States
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Amsterdam UMC, Locatie VUMC
Amsterdam, , Netherlands
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Centro Integral Oncologico Clara Campal
Madrid, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-000907-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
H-200-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.