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

Study acronym: HPVDCVax
StatusCompleted
PhasePhase 1/2
Started
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Record History

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  1. Trial completed Show 5 more changesShow less
    • Study completion date changed from estimate of Aug 2026 to Mar 27, 2026
    • Primary completion date changed from estimate of Nov 2025 to Oct 15, 2025
    • Eligibility criteria expanded, about 44 words
    • Study description expanded, about 8 words
    • Site details revised
  2. Primary completion date: Aug 2025 to Nov 2025v4
  3. Re-verified, no change to tracked fieldsv3
  4. Eligibility criteria expanded, about 25 wordsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06007092
Lead Sponsor Gustave Roussy, Cancer Campus, Grand Paris
Collaborators: LinKinVax
Conditions
(from sponsor)		 Head and Neck Carcinoma, Adult Disease
Related terms Disease
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov