Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer (NCT06007092) | Clinical Trial Compass
RecruitingPhase 1/2
Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer
France24 participantsStarted 2023-07-31
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Subjects 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 assessment has been performed, the subject can be enrolled if the result shows HPV16 positivity. Confirmation of HPV16 positive status will be performed retrospectively by the central laboratory on archived tissue. Formalin- fixed tumour biopsies or surgical piece before local radical treatment can be optionally available for translational research.
✓. 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 study drug administration is 18 to 20 weeks.
✓. 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 radiotherapy or radiochemotherapy without surgery).
What they're measuring
1
immunological outcomes: The frequency (%) of HPV16-specific T cells
Timeframe: at the end of the study, 24 months after the first inclusion
2
recommended phase 2 dose (mg) (RP2D) of poly-ICLC-adjuvanted CD40HVac
Timeframe: 1year after the last visit of last patient
✓. 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)
Exclusion criteria
✕. 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 protocol therapy, or interfere with the interpretation of study results.
✕. Subjects with active, known, diagnosed or suspected auto-immune disease. Subjects suffering from vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring thyroid hormone replacement therapy, or psoriasis not requiring systemic treatment can be enrolled.
✕. 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 corticosteroids or absorbed topical corticosteroids (doses ≥ 10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical corticosteroids and adrenal replacement doses \< 10 mg daily prednisone or equivalent are permitted.
✕. Subjects requiring maintenance treatment with immunosuppressive doses of systemic corticosteroids. Subjects being treated with a short course of corticosteroids (\> 10 mg/day prednisone equivalents) should discontinue this therapy at least 2 weeks prior to start of study treatment.
✕. 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.