Oropharyngeal Squamous Cell Carcinoma (SCC)Phase 1NCT06589609
Phase 1 Clinical Trial of FluBHPVE6E7 Immunotherapy for HPV16-Associated Oropharyngeal Cancer
A Phase 1 study testing FluBHPVE6E7 in people with Oropharyngeal Squamous Cell Carcinoma (SCC), run by BlueSky Immunotherapies GmbH at 1 site in Austria.
Trial summary
A clinical study of an immunotherapy in patients with head or neck cancers associated with the HPV16 virus Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Oropharyngeal Squamous Cell Carcinoma (SCC)
- What is being tested?
- FluBHPVE6E7
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- 23 Aug 2024to Nov 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male patients, 18-65 years of age, with newly diagnosed, histologically confirmed p16- and HPV16-positive oropharyngeal squamous cell carcinoma with locoregional advanced disease including the following stages:
- T2N2-3, M0
- T3N0-3, M0
- T4N0-3, M0
- Primary tumour accessible for biopsy and intratumoural administration
- No evidence of distant metastatic disease (HPV16-positive secondary tumours are permissible)
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- Karnofsky 100 - 70 (ECOG 0 or 1)
- Life expectancy of at least 6 months
- Normal screening ECG or screening ECG with no clinically significant findings requiring immediate treatment, as judged by the investigator
- Women of childbearing potential: Negative serum pregnancy test at screening
- Agree to use a reliable form of contraception until the end of the study treatment period.
- Provides written informed consent
Who cannot join
- Distant metastases
- Secondary, not HPV16-associated, malignancy
- History of malignancy other than the target malignancy to be investigated in this trial unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
- Clinically significant out of range haematological, renal or hepatic laboratory tests which cannot be explained by the underlying disease
- Any vaccination within 1 week before day 0
- Active significant viral infections including influenza, CMV, and EBV within 4 weeks before receiving study treatment
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- Co-infection with hepatitis B, hepatitis C, or HIV or having other immune deficient states
- Influenza-like illness (ILI) within 4 weeks before day 0
- Known hypersensitivity to Tamiflu or any of its components
- Pregnancy, breastfeeding
- Serious, concomitant disorder, including active systemic infection requiring treatment
- Proven or suspected systemic lupus erythematosus, thyroiditis, inflammatory bowel disease including Crohn's disease or multiple sclerosis
- Immunosuppression including any concurrent condition requiring the continued use of systemic steroids, or the use of immunosuppressive agents, disease modifying doses of anti-rheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate), and biologic disease modifying drugs such as TNF-α inhibitors (e.g. infliximab, adalimumab or etanercept). Corticosteroids must be discontinued \> 4 weeks prior to day 0 of study medication administration. Eye drops or ear drops containing corticosteroids are permissible.
- Prior major surgery within 4 weeks before day 0
- Any current significant cardiac, hepatic or renal disease or history of clinically significant, medically unstable disease (e.g. chronic renal failure; angina, myocardial ischemia or infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmias)
- Participation in another experimental protocol/use of investigational drug within two months before day 0
- Any condition that, in the judgment of the investigator, might prevent safe participation in the study or interfere with study objectives
- Unability to comply with the protocol requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University Vienna
Vienna, 1090
Department of Clinical Pharmacology, +43140400 ext. 29800, klin-pharmakologie@meduniwien.ac.at
About this study
Official title: A Phase 1 Study of FluBHPVE6E7 Immunotherapy in Patients With HPV16- Associated Oropharyngeal Squamous Cell Carcinoma
A clinical study of an immunotherapy in patients with head or neck cancers associated with the HPV16 virus
Read the detailed description
Squamous cell carcinomas of the head and neck (HNSCC) rank as the sixth most common cancer globally, with approximately 575,000 new cases diagnosed each year. In recent years, there has been a rising incidence in younger patients who have limited exposure to traditional risk factors such as smoking and alcohol. This increase is closely associated with HPV infection, particularly HPV-16, which is strongly linked to oropharyngeal cancer. Treatment for HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) is highly individualized, depending on the disease stage, patient comorbidities, and personal preferences. In this phase 1 study, patients with HPV-16-associated OPSCC are being treated with the immunotherapeutic delNS-vector expressing the HPV-16 oncogenes E6 and E7, administered both intratumorally and intramuscularly.
- Being tested
- FluBHPVE6E7
- Keywords
- immunotherapy, Oropharyngal squamous cell carcinoma, HPV-16, Human papilloma virus, cancer, Head and neck cancer
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluBHPVE6E7Biological
Intratumoral administration for first dose followed by intramuscular administration for subsequent doses at recommended dose level and determined schedule.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | FlubHPVE6E7 Receives: Biological: FluBHPVE6E7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of adverse events (AEs)
To assess the severity of the adverse event is assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Measured: 7 days
Secondary outcomes (9)
Intralesional T-cell infiltration
To assess the intralesional T-cell infiltration in tumour tissue available from surgery or biopsy by immunohistological staining.
Measured: 24 weeks
Biodistribution
To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in nasal secretion samples by RT-qPCR (copies per ml blood).
Measured: 24 weeks
Virus recovery in oropharyngeal secretion samples
To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in oropharyngeal secretion samples by RT-qPCR (copies per sample).
Measured: 7 days
Virus recovery in saliva
To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in saliva samples by RT-qPCR (copies per sample).
Measured: 7 days
Frequency and severity of adverse events (AEs)
To assess the severity of the adverse event according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Measured: 24 weeks
Disease-free survival (DFS)
To assess the length of time after treatment during which the patient remains free from any signs or symptoms of the disease.
Measured: 60 months
Overall survival (OS)
To assess the length of time from the start of treatment or diagnosis until the death of the patient from any cause.
Measured: 60 months
Induction of HPV-specific T-cell response following FluBHPVE6E7 administration
To assess the induction of HPV16 E6- and E7-specific T-cells (%) by IFN-gamma ELISPOT analysis.
Measured: 24 weeks
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration
To assess the induction of systemic vector-specific antibodies by HAI assay.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start23 Aug 2024
- Primary completionNov 2027 (estimated)
- Study completionNov 2029 (estimated)
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 (SCC)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BlueSky Immunotherapies GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589609
- Sponsor's protocol ID
- BS-03
- Other IDs
- 2024-514413-36-00
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of FluBHPVE6E7 Immunotherapy in Patients With HPV16- Associated Oropharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06589609
- Acronym / sponsor ID
- BS-03
- Keywords
- immunotherapy, Oropharyngal squamous cell carcinoma, HPV-16, Human papilloma virus, cancer, Head and neck cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- BlueSky Immunotherapies GmbHIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 19 Sep 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.
A clinical study of an immunotherapy in patients with head or neck cancers associated with the HPV16 virus
Detailed description
Squamous cell carcinomas of the head and neck (HNSCC) rank as the sixth most common cancer globally, with approximately 575,000 new cases diagnosed each year. In recent years, there has been a rising incidence in younger patients who have limited exposure to traditional risk factors such as smoking and alcohol. This increase is closely associated with HPV infection, particularly HPV-16, which is strongly linked to oropharyngeal cancer. Treatment for HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) is highly individualized, depending on the disease stage, patient comorbidities, and personal preferences. In this phase 1 study, patients with HPV-16-associated OPSCC are being treated with the immunotherapeutic delNS-vector expressing the HPV-16 oncogenes E6 and E7, administered both intratumorally and intramuscularly.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Biological: FluBHPVE6E7FlubHPVE6E7 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female or male patients, 18-65 years of age, with newly diagnosed, histologically confirmed p16- and HPV16-positive oropharyngeal squamous cell carcinoma with locoregional advanced disease including the following stages:
- Primary tumour accessible for biopsy and intratumoural administration
- No evidence of distant metastatic disease (HPV16-positive secondary tumours are permissible)
- Karnofsky 100 - 70 (ECOG 0 or 1)
- Life expectancy of at least 6 months
Key exclusion criteria (18 listed)
- Distant metastases
- Secondary, not HPV16-associated, malignancy
- History of malignancy other than the target malignancy to be investigated in this trial unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
- Clinically significant out of range haematological, renal or hepatic laboratory tests which cannot be explained by the underlying disease
- Any vaccination within 1 week before day 0
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 |
|---|---|---|
| FluBHPVE6E7Intratumoral administration for first dose followed by intramuscular administration for subsequent doses at recommended dose level and determined schedule. | Biological | Intervention |
Primary outcome
Frequency and severity of adverse events (AEs)
Time frame: 7 days
To assess the severity of the adverse event is assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
9 secondary outcomes
Intralesional T-cell infiltration
Time frame: 24 weeks
Biodistribution
Time frame: 24 weeks
Virus recovery in oropharyngeal secretion samples
Time frame: 7 days
Virus recovery in saliva
Time frame: 7 days
Frequency and severity of adverse events (AEs)
Time frame: 24 weeks
Disease-free survival (DFS)
Time frame: 60 months
Overall survival (OS)
Time frame: 60 months
Induction of HPV-specific T-cell response following FluBHPVE6E7 administration
Time frame: 24 weeks
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FluBHPVE6E7 in people with Oropharyngeal Squamous Cell Carcinoma (SCC), run by BlueSky Immunotherapies GmbH at 1 site in Austria.
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 12 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical University of Vienna (+43140400 ext. 29800, klin-pharmakologie@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of adverse events (AEs) (time frame: 7 days). 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 19 Sep 2024.