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A Study of HB-202/HB-201 With Pembrolizumab in Patients With HPV16+ Recurrent/Metastatic Oropharyngeal Cancer

NCT06513884 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2025-06-22

No results posted yet for this study

Summary

This is a study of HB-202/HB-201 alternating 2-vector therapy with pembrolizumab (also known as Keytruda®) in people with human papillomavirus subtype 16 positive (HPV16+) head and neck cancer starting in the middle part of the throat, who have not yet received systemic treatment after their cancer spread (metastatic) and/or returned (recurrent) and who are eligible to receive pembrolizumab.

Doctors already use pembrolizumab therapy (with or without chemotherapy) to treat head and neck cancer. However, the treatment does not work well in most people with this type of cancer. HB-202/HB-201 alternating 2-vector therapy with pembrolizumab, which is designated to stimulate a stronger immune attack against HPV16+ tumors, was shown to be safe and suggested to work better than pembrolizumab-only in a small number of participants with HPV16+ head and neck cancer (see H-200-001, NCT04180215).

This trial studies HB-202/HB-201 alternating 2-vector therapy with pembrolizumab in a much larger number of participants from different countries to confirm its benefits for people with HPV16+ head and neck cancer that started in the middle part of the throat compared with pembrolizumab-only therapy. This trial studies whether administering HB-202/HB-201 alternating 2-vector therapy with pembrolizumab works better in more participants by shrinking their tumors and makes them live longer than pembrolizumab-only therapy.

Participants will receive the study treatments by injection into a vein every 3 weeks during the first 3 months and then every 6 weeks until up to about 2 years, which will be followed by a long observation period to continue looking at the safety and clinical benefits after the last dose of study treatment.

Conditions

  • Oropharyngeal Squamous Cell Carcinoma Recurrent

Interventions

DRUG

HB-202/HB-201 alternating 2-vector therapy

Intravenous administration of HB-202 alternating with HB-201, with the first 2 treatment cycles administered every 3 weeks and then every 6 weeks from the third treatment cycle onwards.

DRUG

Placebo

Intravenous administration of matched placebo for HB-202 alternating with matched placebo for HB-201, with the first 2 treatment cycles administered every 3 weeks and then every 6 weeks from the third treatment cycle onwards.

DRUG

Pembrolizumab

Intravenous administration of pembrolizumab, with the first 2 treatment cycles administered at a dosage of 200 mg every 3 weeks and then every 6 weeks from the third treatment cycle onwards administered at a dosage of 400 mg.

Sponsors & Collaborators

  • Hookipa Biotech GmbH

    lead INDUSTRY

Principal Investigators

  • Head of Clinical Development · Hookipa Biotech GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2029-11-30
Completion
2032-04-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06513884 on ClinicalTrials.gov