Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer

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.H

Trial Details

NCT ID
NCT06007092
Phase
PHASE1 / PHASE2
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • HPVDC injection level dose 1
  • placebo injection level dose 1
  • HPVDC injection level dose 2
  • placebo injection level dose 2
Locations (sample)
  • Villejuif, France|48.7939,2.35992

Key Eligibility 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 ar…

For full eligibility, visit ClinicalTrials.gov.

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