Ignite Creation Date:
2024-05-06 @ 1:35 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04062656
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2019-07-12
Brief Title:
Perioperative Immunotherapy vs Chemo-immunotherapy in Patients With Advanced GC and AEG
Sponsor:
University Hospital Essen
Organization:
University Hospital Essen
Study Overview
Official Title:
Perioperative Immunotherapy vs Chemo-immunotherapy Stratified by Early Response Evaluation in Patients With Advanced Gastric Cancer GC and Adenocarcinoma of the Esophago-gastric Junction AEG
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
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:
IMAGINE
Brief Summary:
IMAGINE is a Phase II randomized two-arm chemotherapy controlled modular trial in subjects with histologically confirmed resectable gastric cancer GC or adenocarcinoma of the gastroesophageal junction AEG Up to 22 patients will be included in each arm of the trial
Detailed Description:
This study will determine the rate of pathological complete responses pCR as determined by pathological examination of the resected tumor following preoperative systemic therapy A pCR rate of 15 is expected with neoadjuvant FLOT chemotherapy An increase to 35 is estimated to be clinically relevant when patients are treated with either nivolumab in combination with chemotherapy Arm B or nivolumab and another immuno-oncology IO agent relatlimab in Arm D Additional objectives include resection rate diseasefree survival DFS median overall survival OS patients quality of life QoL and safety and tolerability of the treatment Furthermore translational endpoints will be investigated
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