Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06007092
Status:
RECRUITING
Last Update Posted:
2023-08-23
First Post:
2023-08-02
Brief Title:
Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
Multicentric Randomized Phase IIIa 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:
2024-07
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 E6E7 oncoproteins adjuvanted with poly-ICLC Hiltonol in patients with HPV16 oropharyngeal carcinoma with no evidence of residual or recurrent disease after surgery andor radiochemotherapy
The primary objective is to determine the recommended phase 2 dose RP2D of a poly-ICLCHiltonol-adjuvanted CD40HVac vaccine according to the safety and the capacity to elicit immune responses of different doses Two dose levels of poly-ICLC-adjuvanted CD40HVac will be explored
1st dose level CD40HVac 10 mg with 10 mg poly-ICLC
2nd dose level CD40HVac 30 mg with 10 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-ICLCHiltonol-adjuvanted CD40HVac vaccine according to the safety and the capacity to elicit immune responses of different doses Two dose levels of poly-ICLC-adjuvanted CD40HVac will be explored
1st dose level CD40HVac 10 mg with 10 mg poly-ICLC
2nd dose level CD40HVac 30 mg with 10 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 E6E7 oncoproteins adjuvanted with poly-ICLC Hiltonol in patients with HPV16 oropharyngeal carcinoma with no evidence of residual or recurrent disease after surgery andor radiochemotherapy
The primary objective is to determine the recommended phase 2 dose RP2D of a poly-ICLCHiltonol-adjuvanted CD40HVac vaccine according to the safety and the capacity to elicit immune responses of different doses Two dose levels of poly-ICLC-adjuvanted CD40HVac will be explored
1st dose level CD40HVac 10 mg with 10 mg poly-ICLC
2nd dose level CD40HVac 30 mg with 10 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 51 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 vaccineplacebo 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 ie at Week 6
The primary objective is to determine the recommended phase 2 dose RP2D of a poly-ICLCHiltonol-adjuvanted CD40HVac vaccine according to the safety and the capacity to elicit immune responses of different doses Two dose levels of poly-ICLC-adjuvanted CD40HVac will be explored
1st dose level CD40HVac 10 mg with 10 mg poly-ICLC
2nd dose level CD40HVac 30 mg with 10 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 51 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 vaccineplacebo 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 ie at Week 6
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20223459 | OTHER | CSET number | None |