Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557278
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Combined AlloStimAnti-PD-L1 in 4L MSS Metastatic Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Open-Label Study to Assess the Safety and Efficacy of AlloStim Anti-PDL1 as Fourth Line Therapy in 4L MSS Metastatic Colorectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMUNITY
Brief Summary:
Experimental immunotherapy in chemotherapy-refractory and immunotherapy-refractory metastatic colorectal cancer patients that have progressed or are intolerant to Longsurf TAS-102 - Avastin bevacizumab or Stivarga regorafenib or Fruzaqla fruquintinib combining experimental AlloStim with an anti-programmed death ligand 1 PD-L1 checkpoint inhibitor drug
Detailed Description:
The protocol provides fourth-line experimental treatment for subjects with microsatellite stable MSS proficient mismatch repair pMMR metastatic colorectal cancer These patients do not respond to checkpoint inhibitors This study will investigate whether AlloStim administered weekly in two-21 day cycles with each cycle consisting of 3 weekly intradermal ID doses followed the last week with an intravenous IV dose 3 cycles Days 0 through 49 can prime patients to become responsive to checkpoint inhibition immunotherapy A restaging computed tomography CT scan is conducted on day 56 after the priming and will be compared to the baseline CT scan by Response Evaluation Criteria in Solid Tumors RECIST 11 Scans at day 56 are expected to be read as radiological progression upon restaging after AlloStim priming possibly due to immunological swelling known as pseudoprogression consistent with the presumed inflammatory mechanism of action of AlloStim This mechanism may convert cold tumors to hot tumors The immune cell infiltrates of tumors after AlloStim include T-helper cell type 1 Th1 memory cells which produce interferon-gamma Interferon-gamma is known to increase expression of anti-programmed death ligand 1 PD-L1 checkpoint molecules in the tumor microenvironment Higher PD-L1 expression may convert checkpoint inhibitor unresponsive tumors to become checkpoint inhibitor responsive After two 21-day cycles of AlloStim priming a combination of AlloStim IV boosters and anti-PD-L1 checkpoint therapy with avelumab 800 mg q2 weeks is scheduled between days 63 to day 98 A restaging CT scan at day 112 is then compared to day 56 and baseline to determine if the tumor target lesions39 size has changed An expansion phase providing another cycle of combined AlloStim and avelumab is provided for stable patients from days 119-154 A final restaging CT scan is conducted on Day 168 for all subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None