Condition: Head and Neck Carcinoma · Adult Disease · Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
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.
This description comes directly from the study's public registry record.
Philippe GORPHE, PhD · +33 (0)1 42 11 42 11 · philippe.gorphe@gustaveroussy.fr
Caroline EVEN, Dr · +33 (0)1 42 11 42 11 · Caroline.even@gustaveroussy.fr
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| Gustave Roussy | Villejuif, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06007092