Ignite Creation Date:
2024-05-06 @ 7:42 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02589496
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2015-10-27
Brief Title:
Study of Pembrolizumab in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine Integration of Molecular Subtypes Through Integrative Genomic Analysis
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Phase II Study of Pembrolizumab in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine Integration of Molecular Subtypes Through Integrative Genomic Analysis
Status:
COMPLETED
Status Verified Date:
2022-07
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:
None
Brief Summary:
This is a single-arm single-center open-label trial of pembrolizumab MK-3475 in subjects with advanced gastric or gastroesophageal junction GEJ adenocarcinoma who have progressed after failure of any combination chemotherapy containing a platinum and a fluoropyrimidine agent
Approximately 60 subjects will be enrollment to evaluate the efficacy and safety of pembrolizumab
Enrollment will begin with all subjects without regard for PD-L1 expression status An evaluable specimen for PD-L1 status must be available and confirmed prior to enrollment
All study subjects will be evaluated every 6 weeks - 7 days following the date of IP drug adminstration for the first six months and every 12 weeks - 7 days thereafter until progression of disease is documented with radiologic imaging computed tomography or magnetic resonance imaging
In the expansion cohort cohort B it was expanded on the original cohort based on response analysis and will be opened separately
Of the 5 MSI-high patients who were enrolled on to original cohort all 5 MSI high GC patients 100 response rate demonstrated dramatic response rate
Based on this finding in order to proven Pembrolizumabs efficacy to specific MSI-H GC population we would like enroll 20 more patients in cohort B Based on our screening protocol the prevalence of MSI-high in GC is about 15 Only MSI-high GC patients will be included All the eligibility will be the same
Approximately 60 subjects will be enrollment to evaluate the efficacy and safety of pembrolizumab
Enrollment will begin with all subjects without regard for PD-L1 expression status An evaluable specimen for PD-L1 status must be available and confirmed prior to enrollment
All study subjects will be evaluated every 6 weeks - 7 days following the date of IP drug adminstration for the first six months and every 12 weeks - 7 days thereafter until progression of disease is documented with radiologic imaging computed tomography or magnetic resonance imaging
In the expansion cohort cohort B it was expanded on the original cohort based on response analysis and will be opened separately
Of the 5 MSI-high patients who were enrolled on to original cohort all 5 MSI high GC patients 100 response rate demonstrated dramatic response rate
Based on this finding in order to proven Pembrolizumabs efficacy to specific MSI-H GC population we would like enroll 20 more patients in cohort B Based on our screening protocol the prevalence of MSI-high in GC is about 15 Only MSI-high GC patients will be included All the eligibility will be the same
Detailed Description:
Each subject will participate in the trial from the time the subject signs the Informed Consent Form ICF through the final contact After a screening phase of up to 28 days eligible subjects will receive treatment beginning on Day 1 of each 3-week dosing cycle for pembrolizumab
Treatment with pembrolizumab or paclitaxel will continue until documented disease progression unacceptable adverse events undercurrent illness that prevents further administration of treatment Investigators decision to withdraw the subject subject withdraw consent pregnancy of the subject noncompliance with trial treatment o procedure requirements subject receives 24 months of pembrolizumab or administrative reasons requiring cessation of treatment After the end of treatment each subject will be followed for 30 days for adverse event monitoring serious adverse events and events of clinical interest will be collected for 90 days after the end of treatment or 30 days after the end of treatment if the subject initiates new anticancer therapy whichever is earlier
Subjects within the pembrolizumab arm who discontinue after 24 months of therapy for reasons other than disease progression or intolerability or who discontinue after attaining a CR may be eligible for up to one year of retreatment after they have experienced radiographic disease progression
Subjects who discontinue for reasons other than disease progression will have post-treatment follow-up for disease status until disease progression initiating a non-study cancer treatment withdrawing consent or becoming lost to follow-up
All subjects will be followed by telephone for overall survival until death withdrawal of consent or the end of the study
Treatment with pembrolizumab or paclitaxel will continue until documented disease progression unacceptable adverse events undercurrent illness that prevents further administration of treatment Investigators decision to withdraw the subject subject withdraw consent pregnancy of the subject noncompliance with trial treatment o procedure requirements subject receives 24 months of pembrolizumab or administrative reasons requiring cessation of treatment After the end of treatment each subject will be followed for 30 days for adverse event monitoring serious adverse events and events of clinical interest will be collected for 90 days after the end of treatment or 30 days after the end of treatment if the subject initiates new anticancer therapy whichever is earlier
Subjects within the pembrolizumab arm who discontinue after 24 months of therapy for reasons other than disease progression or intolerability or who discontinue after attaining a CR may be eligible for up to one year of retreatment after they have experienced radiographic disease progression
Subjects who discontinue for reasons other than disease progression will have post-treatment follow-up for disease status until disease progression initiating a non-study cancer treatment withdrawing consent or becoming lost to follow-up
All subjects will be followed by telephone for overall survival until death withdrawal of consent or the end of the study
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