Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06256328
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-01-23
Brief Title:
A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer Including Esophagogastric Junction Cancer
Sponsor:
Ono Pharmaceutical Co Ltd
Organization:
Ono Pharmaceutical Co Ltd
Study Overview
Official Title:
A Randomized Multicenter Double-blind Phase II Study to Compare the Efficacy and Safety of the Treatment With ONO-4578 in Combination With Nivolumab Fluoropyrimidine-based and Platinum- Based Chemotherapy Hereinafter Referred to as Chemotherapy With Those of the Treatment With Placebo in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 HER2-Negative Unresectable Advanced or Recurrent Gastric Cancer Including Esophagogastric Junction Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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 study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy in chemotherapy-naïve participants with HER2- negative unresectable advanced or recurrent gastric cancer including esophagogastric junction cancer
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None