Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532799
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Stomach and Esophageal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Autologous Tumor-Infiltrating Lymphocytes TIL Therapy Combined With Pembrolizumab Keytruda Immunotherapy in Patients With Advanced or Metastatic Refractory Stomach and Esophageal Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
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:
BAH250
Brief Summary:
This Phase III study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes TIL therapy combined with Pembrolizumab Keytruda immunotherapy in patients with advanced or metastatic refractory stomach and esophageal cancer Lifileucel Amtagvi the first FDA-approved TIL therapy has shown significant promise in treating unresectable or metastatic melanoma by leveraging the patients own immune cells to target and destroy cancer cells This study aims to apply a similar approach to stomach and esophageal cancers TILs will be harvested from patients tumors expanded in vitro and infused back into the patients following a non-myeloablative lymphodepletion regimen Pembrolizumab a monoclonal antibody that targets the PD-1 receptor on T cells will be administered to enhance the immune response The primary endpoint is to determine the objective response rate ORR of this combined therapy Secondary endpoints include disease control rate DCR progression-free survival PFS overall survival OS duration of response DOR and quality of life QoL This trial aims to provide a novel personalized treatment option for patients with limited therapeutic alternatives
Detailed Description:
Tumor-infiltrating lymphocytes TILs therapy is an advanced form of adoptive cell therapy that harnesses the patients immune cells to fight cancer Lifileucel Amtagvi the first FDA-approved TIL therapy has demonstrated substantial efficacy in treating unresectable or metastatic melanoma By extracting lymphocytes from the patients tumor expanding them ex vivo and reinfusing them Lifileucel has shown to significantly enhance the immune systems ability to target and destroy cancer cells This promising approach serves as the foundation for the current study aiming to apply a similar methodology to advanced or metastatic refractory stomach and esophageal cancers which typically have poor prognoses and limited treatment options
This trial involves a multi-step treatment process First tumor samples are collected from patients for TIL extraction Following this a lymphodepletion regimen using cyclophosphamide and fludarabine is administered to prepare the body for the infusion of expanded autologous TILs After the TIL infusion Aldesleukin IL-2 is given to stimulate the TILs activity Pembrolizumab Keytruda an immunotherapy that targets the PD-1 receptor on T cells is also administered to further enhance the immune response against the tumor
The primary goal of this trial is to determine the objective response rate ORR of this combined therapy Secondary endpoints include the disease control rate DCR progression-free survival PFS overall survival OS duration of response DOR and changes in the quality of life QoL of patients
Patients will be closely monitored for side effects and reactions during their hospital stay and throughout the follow-up period Safety will be assessed based on the incidence and severity of adverse events while efficacy will be evaluated using RECIST v11 criteria By leveraging the patients own immune cells and combining them with advanced immunotherapies this trial aims to provide a novel personalized treatment option for patients with advanced or metastatic refractory stomach and esophageal cancer building on the success observed with Lifileucel Amtagvi in melanoma treatment
This trial involves a multi-step treatment process First tumor samples are collected from patients for TIL extraction Following this a lymphodepletion regimen using cyclophosphamide and fludarabine is administered to prepare the body for the infusion of expanded autologous TILs After the TIL infusion Aldesleukin IL-2 is given to stimulate the TILs activity Pembrolizumab Keytruda an immunotherapy that targets the PD-1 receptor on T cells is also administered to further enhance the immune response against the tumor
The primary goal of this trial is to determine the objective response rate ORR of this combined therapy Secondary endpoints include the disease control rate DCR progression-free survival PFS overall survival OS duration of response DOR and changes in the quality of life QoL of patients
Patients will be closely monitored for side effects and reactions during their hospital stay and throughout the follow-up period Safety will be assessed based on the incidence and severity of adverse events while efficacy will be evaluated using RECIST v11 criteria By leveraging the patients own immune cells and combining them with advanced immunotherapies this trial aims to provide a novel personalized treatment option for patients with advanced or metastatic refractory stomach and esophageal cancer building on the success observed with Lifileucel Amtagvi in melanoma treatment
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