Who is sponsoring NCT06007092?

NCT06007092 is sponsored by Gustave Roussy, Cancer Campus, Grand Paris.

What drugs are being tested in NCT06007092?

Interventions in NCT06007092: HPVDC injection level dose 1, placebo injection level dose 1, HPVDC injection level dose 2, placebo injection level dose 2.

What condition does NCT06007092 study?

NCT06007092 studies Head and Neck Carcinoma, Adult Disease.

Is NCT06007092 still recruiting?

NCT06007092 is currently recruiting now. Last updated 24 November 2025.

Last reviewed 2025-11-24 · How we verify

NCT06007092: HPVDCVax

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 1/Phase 2 Last updated 24 November 2025

What this trial tests

Phase 1/Phase 2 trial testing HPVDC injection level dose 1 in Head and Neck Carcinoma in 24 participants. Currently enrolling.

Timeline

31 July 2023

Primary endpoint
1 November 2025

1 August 2026

Quick facts

Lead sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Phase	Phase 1/Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	24
Start date	31 July 2023
Primary completion	1 November 2025
Estimated completion	1 August 2026
Sites	1 location across France

Drugs / interventions tested

HPVDC injection level dose 1 — full drug profile →
placebo injection level dose 1 — full drug profile →
HPVDC injection level dose 2
placebo injection level dose 2

Conditions studied

Head and Neck Carcinoma — all drugs for Head and Neck Carcinoma →
Adult Disease — all drugs for Adult Disease →

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris — full company profile →

Who can join

18 and older, any sex, with Head and Neck Carcinoma or Adult Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

immunological outcomes: The frequency (%) of HPV16-specific T cells
Time frame: at the end of the study, 24 months after the first inclusion
The primary immunological outcomes is: The frequency (%) of HPV16-specific T cells will be evaluated using Activation Induced Marker (AIM) assay using CD69 and CD137 (4-1BB) activation markers after a 24 hours stimulation using two validated tests routinely used in vaccine studies including ICS and AIM assays. These tests will be performed in all collected samples at W0, W2, W6, W26 and W48 for th
recommended phase 2 dose (mg) (RP2D) of poly-ICLC-adjuvanted CD40HVac
Time frame: 1year after the last visit of last patient
The recommended phase 2 dose (RP2D) of poly-ICLC-adjuvanted CD40HVac will be determined by the Extensive Steering Committee according to the safety analysis and to the capacity of the vaccine to elicit immune responses. The capacity to elicit immune response will be used to choose the RP2D in the event that several doses of vaccine are acceptable in terms of safety (i.e. that meet of the "go-crite

Sponsor's own 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 (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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Trial watch: anticancer vaccination with dendritic cells.
Borges F, Laureano RS, Vanmeerbeek I, Sprooten J, et al · · 2024 · cited 18× · PMID 39398476 · DOI 10.1080/2162402x.2024.2412876
The current landscape of therapeutic vaccination approaches for treatment of HPV-dependent malignancies.
Audouze-Chaud J, Schlosser AK, Riemer AB. · · 2026 · PMID 41986361 · DOI 10.1038/s41541-026-01426-8
Opportunities and challenges for cancer immunotherapy based on antigen cross-presentation.
Liu P, Zhou Z, Su X, Xu Y, et al · · 2026 · PMID 41758201 · DOI 10.1080/07853890.2026.2635774
Therapeutic vaccines targeting HPV epitopes in human papillomavirus - positive oropharyngeal cancer: a critical review.
Rossi G, Tartaglia FC, Denaro N, Ghidini M, et al · · 2025 · PMID 41635848 · DOI 10.3389/fimmu.2025.1727804

Verify or expand the search:

Other recruiting trials for Head and Neck Carcinoma

Currently open trials in the same condition.

NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
NCT07227792 — Tongue-out Radiation Therapy (TORT) for the Mitigation of Radiotherapy-related Toxicities in Patients With Head and Neck · NA · recruiting
NCT06896695 — A Financial Intervention (Financial Compass) to Identify and Address Financial Hardship Among Head and Neck Cancer Patie · NA · recruiting
NCT07118176 — Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers · Phase 1 · recruiting
NCT06985784 — Virtual Reality Interventions for the Improvement of Depression, Anxiety and Pain in Patients With Head and Neck Cancer · NA · recruiting

Other Gustave Roussy, Cancer Campus, Grand Paris trials

Trials by the same sponsor.

NCT07303387 — Efficacy and Safety of the Valemetostat in Patients With Selected Solid Tumors. · Phase 2 · not yet recruiting
NCT07159451 — A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovaria · Phase 2 · recruiting
NCT06781996 — A Study to Determine the Efficacy of a Digital Self-management Support Tool to Improve the Quality of Life During Adjuva · Phase 3 · recruiting
NCT07016230 — Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and · Phase 2 · recruiting
NCT06902883 — Study on the Effectiveness and Comfort of Innovative Solutions for the Internal Transport of Patients in Wheelchairs in · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06007092 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gustave Roussy, Cancer Campus, Grand Paris
Last refreshed: 24 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06007092.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing