Oropharyngeal Squamous Cell Carcinoma RecurrentPhase 2/3NCT06513884
A Study of HB-202/HB-201 With Pembrolizumab in Patients With HPV16+ Recurrent/Metastatic Oropharyngeal Cancer
A Phase 2/3 study testing HB-202/HB-201 alternating 2-vector therapy and Pembrolizumab in people with Oropharyngeal Squamous Cell Carcinoma Recurrent, run by Hookipa Biotech GmbH.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Squamous Cell Carcinoma Recurrent
- What is being tested?
- HB-202/HB-201 alternating 2-vector therapy and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Apr 2032
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants at least 18 years of age.
- Confirmed recurrent and/or metastatic OPSCC that is considered incurable by local therapies.
- Must not have had prior systemic anticancer therapy, including investigational therapy and non-palliative radiotherapy, administered in the recurrent and/or metastatic setting.
- Confirmed HPV16+ AND PD-L1+ (with a CPS greater or equal to 20) tumor, based on tumor specimen, core, or excisional biopsy samples from a tumor lesion not previously irradiated.
- Must have measurable disease based on RECIST version 1.1 as determined by BICR.
- Eastern Cooperative Oncology Group performance status must be 0 to 1.
- Adequate organ function should be confirmed within 10 days prior to the first dose of study treatment.
Who cannot join
- Has progressive disease within 6 months of completion of curatively intended systemic treatment (including checkpoint inhibitors) for locoregionally advanced OPSCC.
- Life expectancy of less than 3 months and/or rapidly progressing disease, high burden of visceral metastatic disease, or significant tumor burden in anatomically critical areas (e.g., causing significant biliary or respiratory obstruction) who may benefit from a chemotherapy-based treatment regimen.
- History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the trial or interfere with the participant's participation for the full duration of the trial, or such that it is not in the best interest of the patient to participate, in the opinion of the treating Investigator. This includes active cardiovascular disease within 6 months before study entry.
- Is pregnant or breastfeeding or expecting to conceive or father children starting with the screening visit through a minimum of 2 months after the last dose of trial treatment.
- Was discontinued due to a Grade 3 or 4 immune-related AE after receiving prior therapy with a checkpoint inhibitor agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
- Received systemic steroids at a dose of >10 mg/day (prednisone equivalent) for <30 days within 14 days or for ≥30 days within 28 days of the first dose of study treatment.
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- Received live, or live-attenuated vaccine within 30 days of the planned first dose of treatment or anticipates that such a vaccine will be required during the study.
- Participating in or has participated in a study of an investigational agent, or has used an investigational device treatment, within 4 weeks before the first dose of study treatment.
- Has had an allogeneic tissue/solid organ transplant.
- Has known immunodeficiency OR is receiving long-term systemic steroid therapy or any other form of immunosuppressive therapy within 28 days before the first dose of study treatment.
- Known additional malignancy within 2 years before the first dose of study treatment.
- Known CNS metastases and/or carcinomatous meningitis.
- Has severe hypersensitivity (Grade 3 and/or 4) to pembrolizumab and/or any of its excipients.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- History or current evidence of (non-infectious) pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Known history of acquired immunodeficiency syndrome (AIDS). Testing for human immunodeficiency virus (HIV) is not mandatory.
- Known history of hepatitis B virus (defined as hepatitis B surface antigen reactive) or known active hepatitis C virus infection (defined as hepatitis C virus ribonucleic acid [RNA] is detected [qualitative]).
About this study
Official title: A Randomized Double-blinded Phase 2/3 Study of HB-202/HB-201 Alternating 2-Vector Therapy With Pembrolizumab Versus Pembrolizumab-Only for First Line HPV16+ High PD-L1 CPS Recurrent and/or Metastatic Oropharyngeal Squamous Cell Carcinoma
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).
Read more
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.
Read the detailed description
This is a seamless adaptive Phase 2/3, randomized, double-blinded, placebo-controlled, multicenter trial of HB-202/HB-201 alternating 2-vector therapy with the approved drug pembrolizumab in participants with HPV16+ recurrent and/or metastatic oropharyngeal squamous cell carcinoma (OPSCC), whose tumor has a programmed cell death ligand-1 (PD-L1) combined positive score (CPS) greater than or equal to 20 in the first line setting. OPSCC is a type of head and neck squamous cell carcinoma (HNSCC) originating in the oropharyngeal region (tonsil, tongue base, soft palate, or uvula). The study will evaluate the long-term safety and the benefits on objective response rate, overall survival, and progression-free survival of HB-202/HB-201 alternating 2-vector therapy plus pembrolizumab compared with pembrolizumab-only therapy.
Pembrolizumab-only therapy or pembrolizumab plus chemotherapy are currently the first-line therapies used to treat people with recurrent and/or metastatic HNSCC (including HPV+ OPSCC). However, poor prognosis prevails despite pembrolizumab therapy with or without chemotherapy (including patients with PD-L1 CPS greater or equal to 20), where only a minority of patients respond.
HB-202 and HB-201 are genetically engineered, replicating vectors based on the arenaviruses Pichinde virus and lymphocytic choriomeningitis virus, respectively. The HB-202 and HB-201 vectors have been engineered to deliver specific non-oncogenic antigens derived from HPV16, which enables the vectors to stimulate a strong and specific immune response against HPV16+ tumor cells. Pembrolizumab on the other hand is a potent checkpoint inhibitor, which binds to immune cell surface receptors to relieve the typical inhibition of immune surveillance of tumors. In an early phase trial (H-200-001, NCT04180215), HB-202/HB-201 alternating 2-vector therapy with pembrolizumab has shown favorable safety and preliminary anti-tumor activity with an objective response rate higher than previously reported with pembrolizumab-only therapy in participants with HPV16+ OPSCC.
HB-202/HB-201 alternating 2-vector therapy or matched placebo will be administered in treatment cycles. A treatment cycle is defined as one administration of HB-202 plus the post-dose period followed by one administration of HB-201 plus the post-dose period until the next dose. In the first 2 treatment cycles, the HB-202/HB-201 or matched placebo treatment is administered with 200 mg pembrolizumab every 3 weeks. The HB-202/HB-201 or matched placebo treatment is administered with 400 mg pembrolizumab every 6 weeks from the third treatment cycle onwards. Adverse events (AEs) will be monitored for up to 30 days and serious AEs for up to 90 days after the last dose of study treatment. There will be long-term follow-up every 3 months after the last administration of study treatment for all participants until the participant's death, the participant is lost to follow-up or withdraws consent to follow-up, last study-related phone call or visit, or study termination, whichever occurs first.
Participants will be randomized to receive either HB-202/HB-201 alternating 2-vector therapy followed by pembrolizumab or matched placebo (i.e., matched to the respective viral vector) followed by pembrolizumab.
Up to 150 Investigators and study sites in North America, Europe, and other regions of the world are expected to enroll participants in this study.
- Being tested
- HB-202/HB-201 alternating 2-vector therapy, Placebo, Pembrolizumab
- Keywords
- head and neck cancer, squamous cell cancer, head and neck squamous cell carcinoma, HNSCC, oropharyngeal squamous cell carcinoma, human papillomavirus 16, HPV, programmed cell death 1 ligand 1, PD-L1, immune checkpoint inhibitor, immunotherapy, genetic vector, arenavirus
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms, Squamous Cell, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB-202/HB-201 alternating 2-vector therapyDrug
Also called HB-202 intravenous administration alternating with HB-201 intravenous administration, HB-201 & HB-202 two-vector therapy, TheraT® Vector(s) Expressing Human Papillomavirus 16 Positive (HPV16+) Specific Antigens
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.
PlaceboDrug
Also called Matched 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.
PembrolizumabDrug
Also called Keytruda®
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.
| Study group | Role | What they receive |
|---|---|---|
| HB-202/HB-201 alternating 2-vector therapy with pembrolizumab | Experimental | Intravenous injection of HB-202 followed by pembrolizumab alternating with HB-201 followed by pembrolizumab. Receives: Drug: HB-202/HB-201 alternating 2-vector therapy; Drug: Pembrolizumab |
| Matched placebo with pembrolizumab | Placebo comparator | Intravenous injection of matched placebo for HB-202 followed by pembrolizumab alternating with matched placebo for HB-201 followed by pembrolizumab. Receives: Drug: Placebo; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 7.5 years after first dose of study treatment
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 7.5 years after first dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study startDec 2024 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionApr 2032 (estimated)
Why it stopped: Due to the decision by the company not to pursue the development of HB-202 and HB-201 in this indication.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal Squamous Cell Carcinoma RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hookipa Biotech GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Head of Clinical Development, Study director, Hookipa Biotech GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513884
- Sponsor's protocol ID
- H-200-004
- Status last verified
- Feb 2025
- First submitted
- 17 Jul 2024
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blinded Phase 2/3 Study of HB-202/HB-201 Alternating 2-Vector Therapy With Pembrolizumab Versus Pembrolizumab-Only for First Line HPV16+ High PD-L1 CPS Recurrent and/or Metastatic Oropharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06513884
- Acronym / sponsor ID
- H-200-004
- Keywords
- head and neck cancer, squamous cell cancer, head and neck squamous cell carcinoma, HNSCC, oropharyngeal squamous cell carcinoma, human papillomavirus 16, HPV, programmed cell death 1 ligand 1
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the decision by the company not to pursue the development of HB-202 and HB-201 in this indication.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hookipa Biotech GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2024 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Apr 2032 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a seamless adaptive Phase 2/3, randomized, double-blinded, placebo-controlled, multicenter trial of HB-202/HB-201 alternating 2-vector therapy with the approved drug pembrolizumab in participants with HPV16+ recurrent and/or metastatic oropharyngeal squamous cell carcinoma (OPSCC), whose tumor has a programmed cell death ligand-1 (PD-L1) combined positive score (CPS) greater than or equal to 20 in the first line setting. OPSCC is a type of head and neck squamous cell carcinoma (HNSCC) originating in the oropharyngeal region (tonsil, tongue base, soft palate, or uvula). The study will evaluate the long-term safety and the benefits on objective response rate, overall survival, and progression-free survival of HB-202/HB-201 alternating 2-vector therapy plus pembrolizumab compared with pembrolizumab-only therapy.
Pembrolizumab-only therapy or pembrolizumab plus chemotherapy are currently the first-line therapies used to treat people with recurrent and/or metastatic HNSCC (including HPV+ OPSCC). However, poor prognosis prevails despite pembrolizumab therapy with or without chemotherapy (including patients with PD-L1 CPS greater or equal to 20), where only a minority of patients respond.
HB-202 and HB-201 are genetically engineered, replicating vectors based on the arenaviruses Pichinde virus and lymphocytic choriomeningitis virus, respectively. The HB-202 and HB-201 vectors have been engineered to deliver specific non-oncogenic antigens derived from HPV16, which enables the vectors to stimulate a strong and specific immune response against HPV16+ tumor cells. Pembrolizumab on the other hand is a potent checkpoint inhibitor, which binds to immune cell surface receptors to relieve the typical inhibition of immune surveillance of tumors. In an early phase trial (H-200-001, NCT04180215), HB-202/HB-201 alternating 2-vector therapy with pembrolizumab has shown favorable safety and preliminary anti-tumor activity with an objective response rate higher than previously reported with pembrolizumab-only therapy in participants with HPV16+ OPSCC.
HB-202/HB-201 alternating 2-vector therapy or matched placebo will be administered in treatment cycles. A treatment cycle is defined as one administration of HB-202 plus the post-dose period followed by one administration of HB-201 plus the post-dose period until the next dose. In the first 2 treatment cycles, the HB-202/HB-201 or matched placebo treatment is administered with 200 mg pembrolizumab every 3 weeks. The HB-202/HB-201 or matched placebo treatment is administered with 400 mg pembrolizumab every 6 weeks from the third treatment cycle onwards. Adverse events (AEs) will be monitored for up to 30 days and serious AEs for up to 90 days after the last dose of study treatment. There will be long-term follow-up every 3 months after the last administration of study treatment for all participants until the participant's death, the participant is lost to follow-up or withdraws consent to follow-up, last study-related phone call or visit, or study termination, whichever occurs first.
Participants will be randomized to receive either HB-202/HB-201 alternating 2-vector therapy followed by pembrolizumab or matched placebo (i.e., matched to the respective viral vector) followed by pembrolizumab.
Up to 150 Investigators and study sites in North America, Europe, and other regions of the world are expected to enroll participants in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HB-202/HB-201 alternating 2-vector therapy with pembrolizumab | Experimental | Drug: HB-202/HB-201 alternating 2-vector therapy, Drug: PembrolizumabIntravenous injection of HB-202 followed by pembrolizumab alternating with HB-201 followed by pembrolizumab. |
| Matched placebo with pembrolizumab | Placebo comparator | Drug: Placebo, Drug: PembrolizumabIntravenous injection of matched placebo for HB-202 followed by pembrolizumab alternating with matched placebo for HB-201 followed by pembrolizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants at least 18 years of age.
- Confirmed recurrent and/or metastatic OPSCC that is considered incurable by local therapies.
- Must not have had prior systemic anticancer therapy, including investigational therapy and non-palliative radiotherapy, administered in the recurrent and/or metastatic setting.
- Confirmed HPV16+ AND PD-L1+ (with a CPS greater or equal to 20) tumor, based on tumor specimen, core, or excisional biopsy samples from a tumor lesion not previously irradiated.
- Must have measurable disease based on RECIST version 1.1 as determined by BICR.
Key exclusion criteria (18 listed)
- Has progressive disease within 6 months of completion of curatively intended systemic treatment (including checkpoint inhibitors) for locoregionally advanced OPSCC.
- Life expectancy of less than 3 months and/or rapidly progressing disease, high burden of visceral metastatic disease, or significant tumor burden in anatomically critical areas (e.g., causing significant biliary or respiratory obstruction) who may benefit from a chemotherapy-based treatment regimen.
- History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the trial or interfere with the participant's participation for the full duration of the trial, or such that it is not in the best interest of the patient to participate, in the opinion of the treating Investigator. This includes active cardiovascular disease within 6 months before study entry.
- Is pregnant or breastfeeding or expecting to conceive or father children starting with the screening visit through a minimum of 2 months after the last dose of trial treatment.
- Was discontinued due to a Grade 3 or 4 immune-related AE after receiving prior therapy with a checkpoint inhibitor agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB-202/HB-201 alternating 2-vector therapyAlso: HB-202 intravenous administration alternating with HB-201 intravenous administration, HB-201 & HB-202 two-vector therapy, TheraT® Vector(s) Expressing Human Papillomavirus 16 Positive (HPV16+) Specific AntigensIntravenous 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 | HB-202/HB-201 alternating 2-vector therapy with pembrolizumab |
| PlaceboAlso: Matched placeboIntravenous 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 | Matched placebo with pembrolizumab |
| PembrolizumabAlso: Keytruda®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. | Drug | HB-202/HB-201 alternating 2-vector therapy with pembrolizumab, Matched placebo with pembrolizumab |
Primary outcome
Objective response rate - Blinded independent central review (BICR)
Time frame: Up to 7.5 years after first dose of study treatment
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.
Overall survival
Time frame: Up to 7.5 years after first dose of study treatment
Overall survival defined as the time from the date of randomization to the date of death from any cause.
15 secondary outcomes
Progression-free survival - BICR
Time frame: Up to 7.5 years after first dose of study treatment
Duration of response - BICR
Time frame: Up to 7.5 years after first dose of study treatment
Disease control rate - BICR
Time frame: Up to 7.5 years after first dose of study treatment
Progression-free survival on next-line therapy
Time frame: Up to 7.5 years after first dose of study treatment
Objective response rate - Investigator
Time frame: Up to 7.5 years after first dose of study treatment
Progression-free survival - Investigator
Time frame: Up to 7.5 years after first dose of study treatment
Duration of response - Investigator
Time frame: Up to 7.5 years after first dose of study treatment
Disease control rate - Investigator
Time frame: Up to 7.5 years after first dose of study treatment
Proportion of participants with AEs - overall
Time frame: Up to 7.5 years after first dose of study treatment
Adjusted on-study year rate of AEs
Time frame: Up to 7.5 years after first dose of study treatment
Proportion of participants with laboratory abnormality - overall
Time frame: Up to 2 years after first dose of study treatment
Adjusted on-study yearly rate of laboratory abnormality
Time frame: 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
Time frame: Up to 7.5 years after first dose of study treatment
Participant-reported health-related quality of life - EORTC QLQ-C30
Time frame: Up to 7.5 years after first dose of study treatment
Participant-reported health-related quality of life - EORTC QLQ-H&N35
Time frame: Up to 7.5 years after first dose of study treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Active, not recruitingPhase 3
A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)
Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Head of Clinical Development study director
Hookipa Biotech GmbH
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HB-202/HB-201 alternating 2-vector therapy and Pembrolizumab in people with Oropharyngeal Squamous Cell Carcinoma Recurrent, run by Hookipa Biotech GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate - Blinded independent central review (BICR) (time frame: Up to 7.5 years after first dose of study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.