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New treatment option for Oropharyngeal Squamous Cell Carcinoma (SCC)
Official title Phase 1 Clinical Trial of FluBHPVE6E7 Immunotherapy for HPV16-Associated Oropharyngeal Cancer
ClinicalTrials.gov ID: NCT06589609
What this study is testing
What is FluBHPVE6E7?
FluBHPVE6E7 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for oropharyngeal squamous cell carcinoma (scc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A clinical study of an immunotherapy in patients with head or neck cancers associated with the HPV16 virus
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Female or male patients, 18-65 years of age, with newly diagnosed, histologically confirmed p16- and HPV16-positive oropharyngeal squamous cell...
- T2N2-3, M0
- T3N0-3, M0
- T4N0-3, M0
- Primary tumour accessible for biopsy and intratumoural administration
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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)
- 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
- 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...
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.