Ignite Creation Date:
2024-05-06 @ 2:12 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04249739
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2020-01-21
Brief Title:
Pembrolizumab CapecitabineOxaliplatin CapeOx -HER2 Nagative and Pembrolizumab Trastuzumab CisplatinCapecitabine HER2 Positive
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Phase II Study of Pembrolizumab CapecitabineOxaliplatin CapeOxHER2 Negative ARM or Pembrolizumab Trastuzumab CapecitabineCisplatin HER2 Positive ARM in Metastatic GC as First-line Treatment
Status:
ACTIVE_NOT_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 study is an open-label single arm phase II trial the efficacy and safety of pembrolizumab CapeOx HER2 negative ARM or pembrolizumab Trastuzumab CapecitabineCisplatin HER2 positive ARM as first line therapy in advanced gastric or gastroesophageal junction GEJ adenocarcinoma
Detailed Description:
Cohort A is allocated for the patients with Advanced Gastric or Gastroesophageal Junction GEJ Adenocarcinoma who confirmed with HER2 negative and approximately 78 subjects will be enrollment to evaluate the efficacy and safety of pembrolizumab Capecitabineoxaliplatin
Cohort B is allocated for the patients with Advanced Gastric or Gastroesophageal Junction GEJ Adenocarcinoma who confirmed with HER2 positive and approximately 15 subjects will be enrollment to evaluate the efficacy and safety of pembrolizumab Trastuzumab CapecitabineCisplatin
1 Cycle Day 1 through Day 21
Planned Biopsy Analysis immediate pre-treatment biopsy before chemotherapy Newly-obtained specimens are defined as FFPE-preserved blocks or fresh tissue collected up to 12 weeks prior to C1D1
2on treatment primary tumor biopsy C2D1 - 3 days window before administration of C2D1 to explore whether tumor has change in characters ie immune desert to immune infiltration 3on treatment primary tumor biopsy C7D1 - 3 days window before administration of C7D1 to explore whether tumor has change in characters ie immune desert to immune infiltration 4At progression biopsy will be optional whenever the tumor biopsy is feasible
Cohort B is allocated for the patients with Advanced Gastric or Gastroesophageal Junction GEJ Adenocarcinoma who confirmed with HER2 positive and approximately 15 subjects will be enrollment to evaluate the efficacy and safety of pembrolizumab Trastuzumab CapecitabineCisplatin
1 Cycle Day 1 through Day 21
Planned Biopsy Analysis immediate pre-treatment biopsy before chemotherapy Newly-obtained specimens are defined as FFPE-preserved blocks or fresh tissue collected up to 12 weeks prior to C1D1
2on treatment primary tumor biopsy C2D1 - 3 days window before administration of C2D1 to explore whether tumor has change in characters ie immune desert to immune infiltration 3on treatment primary tumor biopsy C7D1 - 3 days window before administration of C7D1 to explore whether tumor has change in characters ie immune desert to immune infiltration 4At progression biopsy will be optional whenever the tumor biopsy is feasible
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