Ignite Creation Date:
2024-05-06 @ 1:50 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04130854
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-20
First Post:
2019-10-15
Brief Title:
INNATE Immunotherapy During Neoadjuvant Therapy for Rectal Cancer
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
INNATE Immunotherapy During Neoadjuvant Therapy for Rectal Cancer a Phase II Randomized Multi-center Trial With and Without APX005M an Anti-CD40 Agonist
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
Determine the complete pathologic complete response pCR rate in patients with locally advanced rectal adenocarcinoma
Detailed Description:
A phase II randomized trial 32 with short course radiotherapy followed by mFOLFOX chemotherapy prior to trans abdominal resection with or without an antiCD40 agonist antibody APX005M There will be continuous safety assessment for at least 6 patients Planned accrual of 58 patients An interim analysis after 30 patients have completed treatment and there will be early stopping criteria for futility or efficacy Short course radiotherapy will consist of 5Gy x 5 to the pelvis and patients on APX005M arm will receive one infusion during radiotherapy course have a two week break then start FOLFOX with APX005M in conjunction with five out of six cycles of chemotherapy Patients will be restaged and then undergo definitive surgery
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