ENT/Head and Neck Cancers

HPV.DCVax

Multicentric randomized phase I/IIa trial of the safety and immunogenicity of a;therapeutic anti-HPV DC targeting vaccine in patients with Human papillomavirus;(HPV)-positive oropharyngeal cancer.
  • Open at Paris since : 02/02/2024
  • Target : Adult
  • Phase : Phase I/II

Trial description

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 (HiltonolÀ) 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
Url of the trial

Main investigator

CHRISTOPHE LE TOURNEAU

Professeur - Médecin

Contact
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