Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614140
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Personalized Neoantigen Cancer Vaccine for Patients with Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IIIb Study of Personalized Neoantigen Peptide-Based Cancer Vaccine for Patients with Solid Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial aims to evaluate the safety immunogenicity and preliminary efficacy of a personalized neoantigen peptide vaccine in patients with advanced cancer or at high risk of recurrence The study is designed for patients whose tumors have specific mutations identifiable through genomic sequencing These mutations known as neoantigens are unique to each patients cancer and serve as the target for the personalized vaccine
Eligible patients will undergo genomic analysis including whole exome sequencing and RNA sequencing to identify these neoantigens A custom peptide vaccine will then be produced and formulated to target these neoantigens The trial consists of a preparation phase a treatment phase with priming and booster vaccinations and a follow-upmaintenance period of one year The study will assess immune responses clinical efficacy and potential toxicities By leveraging the immune systems ability to recognize and attack cancer cells this vaccine aims to provide a new treatment option for patients with limited alternatives
Eligible patients will undergo genomic analysis including whole exome sequencing and RNA sequencing to identify these neoantigens A custom peptide vaccine will then be produced and formulated to target these neoantigens The trial consists of a preparation phase a treatment phase with priming and booster vaccinations and a follow-upmaintenance period of one year The study will assess immune responses clinical efficacy and potential toxicities By leveraging the immune systems ability to recognize and attack cancer cells this vaccine aims to provide a new treatment option for patients with limited alternatives
Detailed Description:
This Phase IbII open-label single-center study investigates the safety immunogenicity and preliminary efficacy of a personalized neoantigen peptide vaccine in patients with advanced cancer or high risk of recurrence The trial aims to enroll 15-35 eligible patients and is divided into three phases preparation treatment and follow-up
Preparation Phase Patients undergo genomic analysis using whole exome sequencing and RNA sequencing to identify specific neoantigens from their tumor tissues Based on these findings a personalized neoantigen peptide vaccine is produced and formulated Poly-ICLC an immune adjuvant is administered intramuscularly twice weekly for four weeks prior to the first vaccine dose to enhance immune readiness
Treatment Phase The neoantigen peptide vaccine is administered alongside Poly-ICLC on days 1 4 8 15 and 22 A checkpoint inhibitor eg anti-PD-1 or anti-PD-L1 will be introduced once neoantigen-specific T cell responses are detected to prevent immune exhaustion and sustain the immune response Booster injections of the neoantigen vaccine are scheduled for weeks 12 and 20 Immune responses and adverse events will be closely monitored throughout this phase
Follow-up Phase During the follow-up phase checkpoint inhibitors administered per standard regimen and Poly-ICLC administered twice monthly will be continued to maintain immune activity and ensure a lasting anti-tumor response Safety immune activity and clinical outcomes will be closely monitored over a one-year period
The primary endpoints include safety and immunogenicity measured by adverse event monitoring and T-cell activation assays Secondary endpoints will assess clinical efficacy including tumor response rates progression-free survival and overall survival Exploratory endpoints will involve biomarker analysis and immune profiling to correlate clinical outcomes with specific immune responses
This study aims to validate the hypothesis that personalized neoantigen peptide vaccines in combination with immune adjuvants and checkpoint inhibitors can elicit strong immune responses and improve clinical outcomes in patients with advanced or high-risk recurrent cancers especially where standard therapies have failed
Preparation Phase Patients undergo genomic analysis using whole exome sequencing and RNA sequencing to identify specific neoantigens from their tumor tissues Based on these findings a personalized neoantigen peptide vaccine is produced and formulated Poly-ICLC an immune adjuvant is administered intramuscularly twice weekly for four weeks prior to the first vaccine dose to enhance immune readiness
Treatment Phase The neoantigen peptide vaccine is administered alongside Poly-ICLC on days 1 4 8 15 and 22 A checkpoint inhibitor eg anti-PD-1 or anti-PD-L1 will be introduced once neoantigen-specific T cell responses are detected to prevent immune exhaustion and sustain the immune response Booster injections of the neoantigen vaccine are scheduled for weeks 12 and 20 Immune responses and adverse events will be closely monitored throughout this phase
Follow-up Phase During the follow-up phase checkpoint inhibitors administered per standard regimen and Poly-ICLC administered twice monthly will be continued to maintain immune activity and ensure a lasting anti-tumor response Safety immune activity and clinical outcomes will be closely monitored over a one-year period
The primary endpoints include safety and immunogenicity measured by adverse event monitoring and T-cell activation assays Secondary endpoints will assess clinical efficacy including tumor response rates progression-free survival and overall survival Exploratory endpoints will involve biomarker analysis and immune profiling to correlate clinical outcomes with specific immune responses
This study aims to validate the hypothesis that personalized neoantigen peptide vaccines in combination with immune adjuvants and checkpoint inhibitors can elicit strong immune responses and improve clinical outcomes in patients with advanced or high-risk recurrent cancers especially where standard therapies have failed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None