A Phase 2/3 Study of HB-202/HB-201 With Pembrolizumab in Patients With HPV16+ Recurrent/Metastatic Oropharyngeal Cancer
NCT Number: NCT06513884
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Oropharyngeal Squamous Cell Carcinoma Recurrent
Interventions: DRUG: HB-202/HB-201 alternating 2-vector therapy|DRUG: Placebo|DRUG: Pembrolizumab
Sponsor: Hookipa Biotech GmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2032-04

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.

Primary Outcome Measures: Objective response rate - Blinded independent central review (BICR), Objective response rate (ORR) defined as the proportion of participants with a confirmed best overall response of complete response or partial response, as assessed by BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1., Up to 7.5 years after first dose of study treatment|Overall survival, Overall survival defined as the time from the date of randomization to the date of death from any cause., Up to 7.5 years after first dose of study treatment
Secondary Outcome Measures: Progression-free survival - BICR, Progression-free survival (PFS) defined as the time from the date of randomization to the date of progressive disease, as assessed by BICR based on RECIST version 1.1, or to the date of death from any cause, whichever occurs first., Up to 7.5 years after first dose of study treatment|Duration of response - BICR, Duration of response (DOR) defined as the time from the date of the first objective response (complete or partial response) to the date of progressive disease as assessed by BICR based on RECIST version 1.1, or to the date of death from any cause, whichever occurs first., Up to 7.5 years after first dose of study treatment|Disease control rate - BICR, Disease control rate (DCR) defined as the proportion of participants with a confirmed best overall response of complete response, partial response, or stable disease as assessed by BICR based on RECIST version 1.1., Up to 7.5 years after first dose of study treatment|Progression-free survival on next-line therapy, Progression-free survival on next-line therapy defined as the time from the date of randomization to the Investigator-reported date of progression on next-line therapy, or to the date of death from any cause, whichever occurs first., Up to 7.5 years after first dose of study treatment|Objective response rate - Investigator, ORR defined as the proportion of participants with a confirmed best overall response of complete response or partial response, as assessed by the Investigator based on RECIST version 1.1 and immune RECIST (iRECIST)., Up to 7.5 years after first dose of study treatment|Progression-free survival - Investigator, PFS defined as the time from the date of randomization to the date of progressive disease, as assessed by the Investigator based on RECIST version 1.1 and iRECIST, or to the date of death from any cause, whichever occurs first., Up to 7.5 years after first dose of study treatment|Duration of response - Investigator, DOR defined as the time from the date of the first objective response (complete or partial response) to the date of progressive disease as assessed by the Investigator based on RECIST version 1.1 and iRECIST, or to the date of death from any cause, whichever occurs first., Up to 7.5 years after first dose of study treatment|Disease control rate - Investigator, DCR defined as the proportion of participants with a confirmed best overall response of complete response, partial response, or stable disease as assessed by the Investigator based on RECIST version 1.1 and iRECIST., Up to 7.5 years after first dose of study treatment|Proportion of participants with AEs - overall, Overall occurrence of AEs by relationship to study treatment, type, grade, and seriousness., Up to 7.5 years after first dose of study treatment|Adjusted on-study year rate of AEs, Adjusted on-study yearly rate of AEs by relationship to study treatment, type, grade, and seriousness., Up to 7.5 years after first dose of study treatment|Proportion of participants with laboratory abnormality - overall, Overall occurrence of laboratory abnormality by laboratory test., Up to 2 years after first dose of study treatment|Adjusted on-study yearly rate of laboratory abnormality, Adjusted on-study yearly rate of laboratory abnormality by laboratory test., Up to 2 years after first dose of study treatment|Participant-reported health-related quality of life - European Quality of Life scale EQ-5D-3L, European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L) score by dimension and item., Up to 7.5 years after first dose of study treatment|Participant-reported health-related quality of life - EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) score by scale and item., Up to 7.5 years after first dose of study treatment|Participant-reported health-related quality of life - EORTC QLQ-H&N35, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck Cancer module 35 (EORTC QLQ-H\&N35) score by scale and item., Up to 7.5 years after first dose of study treatment