Ignite Creation Date:
2024-05-06 @ 3:32 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02318901
Status:
TERMINATED
Last Update Posted:
2019-10-21
First Post:
2014-12-08
Brief Title:
Pembrolizumab and Monoclonal Antibody Therapy in Advanced Cancer
Sponsor:
Western Regional Medical Center
Organization:
Western Regional Medical Center
Study Overview
Official Title:
A Phase IbII Study of Pembrolizumab and Monoclonal Antibody Therapy in Patients With Advanced Cancer PembroMab
Status:
TERMINATED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI no longer at sight Results not collected
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PembroMab
Brief Summary:
There will be two phase II cohorts for pembro plus trastuzumab one cohort will be for patients with unresectable HER2 overexpressing gastric or GEJ cancers the other cohort will be for patients with HER2 overexpressing metastatic breast cancer MBC The pembro plus ado-trastuzumab emtansine phase II arm will be for patients with HER2 overexpressing MBC There will be two phase II cohorts for pembro plus cetuximab one cohort will be for patients with HNSCC the other cohort will be for patients with K-ras B-raf N-ras wildtype metastatic CRC
Detailed Description:
Pembrolizumab 2mgkg administered intravenously over 30 minutes every 3 weeks Pembrolizumab will be infused prior to the start of the assigned monoclonal antibody Mab arm
Dosing for the Mab arms will begin as follows
Arm 1 Cycle length is 21 days Intravenous iv trastuzumab 6 mgkg on day 1 every 21 days
Arm 2 Cycle length is 21 days iv ado-trastuzumab emtansine 36 mgkg on day 1 every 21 days
Arm 3 Cycle length is 21 days iv cetuximab 400 mgm2 on cycle 1 day 1 then iv cetuximab 250 mgm2 on day 8 Each subsequent cycle will be iv cetuximab 250 mgm2 on days 1 and 8 every 21 days
Dosing for the Mab arms will begin as follows
Arm 1 Cycle length is 21 days Intravenous iv trastuzumab 6 mgkg on day 1 every 21 days
Arm 2 Cycle length is 21 days iv ado-trastuzumab emtansine 36 mgkg on day 1 every 21 days
Arm 3 Cycle length is 21 days iv cetuximab 400 mgm2 on cycle 1 day 1 then iv cetuximab 250 mgm2 on day 8 Each subsequent cycle will be iv cetuximab 250 mgm2 on days 1 and 8 every 21 days
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?:
False
Is an FDA AA801 Violation?:
None