Ignite Creation Date:
2024-05-06 @ 1:39 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04082364
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2019-09-05
Brief Title:
Combination Margetuximab Retifanlimab Tebotelimab and Chemotherapy Phase 23 Trial in HER2 GastricGEJ Cancer
Sponsor:
MacroGenics
Organization:
MacroGenics
Study Overview
Official Title:
A Phase 23 Trial to Evaluate Margetuximab in Combination With INCMGA00012 and Chemotherapy or MGD013 and Chemotherapy in Patients With Metastatic or Locally Advanced Treatment-naïve HER2-Positive Gastric or Gastroesophageal Junction Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
MAHOGANY
Brief Summary:
This is a Phase 23 randomized open-label study for the treatment of patients with HER2-positive Gastric cancer GC or Gastroesophageal Junction GEJ cancer conducted in two parts
Part A is a single-arm cohort Cohort A 40 to 110 patients will evaluate safety and efficacy of margetuximab plus retifanlimab
Part B Part 1 has 4 arms 50 patientsarm Patients will be randomized to margetuximab plus retifanlimab plus chemotherapy margetuximab plus tebotelimab plus chemotherapy margetuximab plus chemotherapy or trastuzumab plus chemotherapy
Part A is a single-arm cohort Cohort A 40 to 110 patients will evaluate safety and efficacy of margetuximab plus retifanlimab
Part B Part 1 has 4 arms 50 patientsarm Patients will be randomized to margetuximab plus retifanlimab plus chemotherapy margetuximab plus tebotelimab plus chemotherapy margetuximab plus chemotherapy or trastuzumab plus chemotherapy
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?:
None
Is an FDA AA801 Violation?:
None