Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343077
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-27
Brief Title:
Intratumoral and Systemic Hiltonol Poly-ICLC in Prostate Cancer Patients on Active Surveillance
Sponsor:
Ashutosh Kumar Tewari
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Phase II Trial of In-Situ Autologous Vaccination With Intratumoral and Systemic Hiltonol Poly-ICLC Administered to Prostate Cancer Patients on Active Surveillance
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
This is a partially blinded randomized controlled phase II pilot study comparing Poly-ICLC Hiltonol treatment vs no treatment for prostate cancer participants on active surveillance
Detailed Description:
114 prostate cancer participants on active surveillance will be randomized 21 into treatment group A or control group B respectively Enrolled group A study participants will receive standard of care SOC plus intratumoral IT and intramuscular IM injections of study drug Poly-ICLC Hiltonol as follows
Preconditioning week 1 Paired IM Poly-ICLC 15 mg to reduce tumor induced suppression
Immune Priming week 2 intratumor poly-ICLC 10 mg once
Boosting Wk 3 - 10 Paired 15 mg IM poly-ICLC weekly
Maintenance Month 3-12 Paired IM Poly-ICLC once a month
Control patients in group B will receive standard care SOC for patients on Active Surveillance per AUS guidelines
Comparisons of safety and efficacy will be based on data from concurrently randomized participants An independent data and safety monitoring board DSMB will actively monitor interim data for safety efficacy or futility
Seventy-six 76 participants will receive treatment ITIM Poly-ICLC Hiltonol and 38 participants will serve as controls for a total of 114 study participants Participants randomized to the treatment arm will receive standard of care SOC plus ITIM Poly-ICLC Hiltonol Participants in the control arm will receive SOC This is a partially blind randomized controlled phase 2 trial conducted at the Mount Sinai Health System with 114 participants planned for enrollment Eligible participants will be randomly assigned to one of the two groups
There will be an interim analysis conducted after half of the participants 38 receiving Poly-ICLC and 19 controls receiving standard care have completed 1 year of treatment
Preconditioning week 1 Paired IM Poly-ICLC 15 mg to reduce tumor induced suppression
Immune Priming week 2 intratumor poly-ICLC 10 mg once
Boosting Wk 3 - 10 Paired 15 mg IM poly-ICLC weekly
Maintenance Month 3-12 Paired IM Poly-ICLC once a month
Control patients in group B will receive standard care SOC for patients on Active Surveillance per AUS guidelines
Comparisons of safety and efficacy will be based on data from concurrently randomized participants An independent data and safety monitoring board DSMB will actively monitor interim data for safety efficacy or futility
Seventy-six 76 participants will receive treatment ITIM Poly-ICLC Hiltonol and 38 participants will serve as controls for a total of 114 study participants Participants randomized to the treatment arm will receive standard of care SOC plus ITIM Poly-ICLC Hiltonol Participants in the control arm will receive SOC This is a partially blind randomized controlled phase 2 trial conducted at the Mount Sinai Health System with 114 participants planned for enrollment Eligible participants will be randomly assigned to one of the two groups
There will be an interim analysis conducted after half of the participants 38 receiving Poly-ICLC and 19 controls receiving standard care have completed 1 year of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None