MedTrace Logo

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

NCT06007092 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-01

No results posted yet for this study

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.

Conditions

  • Head and Neck Carcinoma
  • Adult Disease

Interventions

BIOLOGICAL

HPVDC injection level dose 1

patient receive 3 injections of vaccine at the same level dose

BIOLOGICAL

placebo injection level dose 1

patient receive 3 injections of vaccine at the same level dose

BIOLOGICAL

HPVDC injection level dose 2

patient receive 3 injections of vaccine at the same level dose

BIOLOGICAL

placebo injection level dose 2

patient receive 3 injections of vaccine at the same level dose

Sponsors & Collaborators

  • LinKinVax

    collaborator UNKNOWN

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • Caroline EVEN, Dr · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-31
Primary Completion
2025-11-30
Completion
2026-08-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06007092 on ClinicalTrials.gov