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Vaccines

10 patients with experimental injection at 1.0 mg

2 patients with experimental injection at 1.0 mg

10 patients with experimental injection at 3.0 mg

2 patients with experimental injection at 3.0 mg

patient receive 3 injections of vaccine at the same level dose

HPVDC injection level dose 1

placebo injection level dose 1

HPVDC injection level dose 2

placebo injection level dose 2

Philippe GORPHE, PhD

Caroline EVEN, Dr

Philippe GORPHE, Dr

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 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. Within each group, patients will be randomized between poly-ICLC- adjuvanted CD40HVac or placebo in a 5:1 ratio.

  12 patients will be treated at each dose level (10 with vaccine and 2 with placebo).

The patients will receive three subcutaneous injections of a poly-ICLC- adjuvanted CD40HVac or placebo:

* The first injection will occur at week 0
* The second injection will occur at week 4 (±7 days)
* The third injection will occur at week 24 (±7 days) Within each dose group, a period of 7 days must be observed between the first administration of vaccine of the first patient of the group and the first administration of vaccine/placebo of the second patient of the group.

A safety monitoring is planned in each dose level group:

* If a grade 5 AE occurs (except if related to cancer) at any time, all vaccinations will be halted, inclusions in the trial will be suspended and an IDSMB meeting convened for evaluation
* If a grade 4 AE related to vaccine occurs at any time, inclusions in the trial will be suspended and an IDSMB meeting convened for evaluation
* If a grade 3 AE related to vaccine occurs at any time and does not resolve or decrease to grade 1 or baseline after 7 days, inclusions in the trial will be suspended and an IDSMB meeting convened for evaluation The IDSMB recommendations as to whether or not to continue the trial after its assessment of the AE will be transmitted to the Steering Committee and to the sponsor.

Enrolment into the second dose group will open depending on the safety data of the first dose group during the safety observation period and after IDSMB and Steering Committee validation. For each patient, this safety observation period begins from the first administration and stops 2 weeks after the second injection, i.e. at Week 6.

Within each group, patients will be randomized between poly-ICLC- adjuvanted CD40HVac or placebo in a 5:1 ratio.

12 patients will be treated at each dose level (10 with vaccine and 2 with placebo).

The patients will receive three subcutaneous injections of a poly-ICLC- adjuvanted CD40HVac or placebo:

* The first injection will occur at week 0
* The second injection will occur at week 4 (±7 days)
* The third injection will occur at week 24 (±7 days)

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

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

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 the durability of the responses.

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-criterion").

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer	NCT06007092	Head and Neck C... Adult Disease	HPVDC injection... placebo injecti... HPVDC injection... placebo injecti...	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris
Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer	NCT06007092	Head and Neck C... Adult Disease	HPVDC injection... placebo injecti... HPVDC injection... placebo injecti...	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris

Spots Global Cancer Trial Database for hpvdc injection level dose 2