Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-25 @ 3:07 PM
Study NCT ID:
NCT06007092
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2023-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer
Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HPVDCVax
Brief 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.
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.
Detailed 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. 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022/3459 | OTHER | CSET number | View |