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New treatment option for Head and Neck Carcinoma
Official title Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer
ClinicalTrials.gov ID: NCT06007092
What this study is testing
What is HPVDC injection level dose 1?
HPVDC injection level dose 1 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for head and neck carcinoma.
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
- This study is a multicentric double-blind placebo-controlled dose escalation trial of a CD40HVac vaccine (humanized anti-CD40 mAb fused to HPV16 E6/E7 oncoproteins) adjuvanted with poly-ICLC (Hiltonol) in patients with HPV16 oropharyngeal carcinoma with no evidence of residual or recurrent disease after surgery and/or radiochemotherapy. The primary objective is to determine the recommended phase 2 dose (RP2D) of a poly-ICLC(Hiltonol)-adjuvanted CD40HVac vaccine according to the safety and the capacity to elicit immune responses of different doses Two dose levels of poly-ICLC-adjuvanted CD40.HVac will be explored 1st dose level: CD40.HVac 1.0 mg, with 1.0 mg poly-ICLC 2nd dose level: CD40.HVac 3.0 mg, with 1.0 mg poly-ICLC The safety data will be reviewed by an IDSMB that will give recommendations.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Males and females ≥ 18 years of age.
- Willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
- people with histologically confirmed oropharyngeal squamous cell carcinoma.
- HPV16 genotyping determined by a specified central reference laboratory with an established polymerase chain reaction (PCR)- based assay on FFPE...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
You likely can't join if
- Clinical evidence on physical or radiological examination of residual or recurrent HPV-driven carcinoma on the primary site, in neck lymph nodes, or...
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or...
- people with active, known, diagnosed or suspected auto-immune disease. people suffering from vitiligo, type I diabetes mellitus, residual...
- Patients diagnosed with active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis within the last 5 years, or another...
- people requiring maintenance treatment with immunosuppressive doses of systemic corticosteroids. people being treated with a short course of...
- Prior treatment with therapeutic anti-HPV vaccines.
See the full eligibility criteria
Who can join
- Males and females ≥ 18 years of age.
- Willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
- people with histologically confirmed oropharyngeal squamous cell carcinoma.
- HPV16 genotyping determined by a specified central reference laboratory with an established polymerase chain reaction (PCR)- based assay on FFPE archived tumor biopsies (or 10 slices of 5µm).If local HPV16 genotype...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Comprehensive curative treatment according to the disease stage and national guidelines, completed at least 16 weeks prior to study drug administration. The recommended duration between end of curative treatment and...
- No evidence of residual or recurrent disease on the last assessment, comprising a physical examination, a head and neck CT-scan or a head and neck MRI, and a thoracic CT Scan (and TEP-scan only for patients traited by...
- Vaccination for Covid and Flu vaccines are authorised 4 weeks before or after the administration of poly-ICLC-adjuvanted CD40HVac (2 weeks during flu period for the Flu vaccine)
- Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to randomization: i) White blood cell count (WBC) ≥ 2 x 109/L ii) Absolute neutrophil count (ANC) ≥ 1.5 x 109/L...
- Participants who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed before randomisation and on the day of initial IMP administration (W0)
- Reproductive status: if heterosexually active female, consistently using an effective method of contraception with partner for sexual activity that could lead to pregnancy from at least 21 days prior to enrolment...
- Condoms (male or female) with or without a spermicide;
- Intrauterine device (IUD);
- Intrauterine hormone releasing system (IUS);
- Hormonal contraception (progesterone only);
- Successful vasectomy in the male partner (considered successful if a participant reports that a male partner has (i) documentation of azoospermia by microscopy, or (ii) a vasectomy more than 2 years ago with no...
- Or not be of reproductive potential, such as having reached menopause (no menses for 1 year without an alternative medical cause) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation.
- Agree not to seek pregnancy including through alternative methods, such as artificial insemination or in vitro fertilization until 4 months after the last administration. Participants who were born male, if...
- Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed.
- Patients must be affiliated to a social security system or beneficiary of the same
What rules you out
- Clinical evidence on physical or radiological examination of residual or recurrent HPV-driven carcinoma on the primary site, in neck lymph nodes, or in any distant site metastasis.
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive...
- people with active, known, diagnosed or suspected auto-immune disease. people suffering from vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring thyroid hormone...
- Patients diagnosed with active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis within the last 5 years, or another condition requiring immunosuppressive doses of medication such as systemic...
- people requiring maintenance treatment with immunosuppressive doses of systemic corticosteroids. people being treated with a short course of corticosteroids (\> 10 mg/day prednisone equivalents) should discontinue this...
- Prior treatment with therapeutic anti-HPV vaccines.
- Invasive surgery (defined as surgical intervention requiring general or spinal anesthesia, and hospital admission) within 28 days prior to start of study treatment.
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus.
- Patient with active infection must be postponed until infection resolution
- people with an uncontrolled or significant heart disease such as long QT syndrome with QTcF \> 480 ms on baseline ECG, NYHA III/IV or uncontrolled arrhythmia.
- History of organ transplantation, including allogenic peripheral stem cell or bone marrow transplantation.
- Participation in another clinical study with an investigational product during the last 6 months and while on study treatment
- Vaccination for Covid and Flu vaccines is not permitted within 4 weeks prior the first vaccination with polyICLC adjuvanted CD40HPVac (2 weeks during flu period for the Flu vaccine.
- Treatment is not permitted within 4 weeks prior the first vaccination and 4 months after the last injection. Furthermore, the use of this medication will be considered as a deviation to the protocol.
- curative treatment within 12 weeks before the first injection,
- Corticosteroids,
- Live attenuated vaccines (such as measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever) or any vaccines that are not live attenuated (eg, tetanus, pneumococcal, Hepatitis A or B) except...
- Immunosuppressive medications (Not excluded: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of oral/parenteral...
- Blood products
- Immunoglobin
- Anti-tuberculosis drugs
- Immunomodulators (such as cytokines or interferons) or immunosuppressive drugs during 8 weeks preceding the screening visit and as of 4 months after the last injection will not be allowed. If any patient needs chronic...
- Antipyretic will not be allowed twelve (12) hours before immunization as preventive treatment of pain or fever.
- Pregnant or breastfeeding women or intending to become pregnant during study
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
The study team makes the final eligibility decision.
Where it's taking place
- Villejuif, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Villejuif, France. Enter your location above to see the nearest site and check your eligibility.
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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.