Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522919
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Sequential Immunochemotherapy Treatment With Pembrolizumab Plus Dendritic Cell DC Vaccine Followed by TrifluridineTipiracil Plus Bevacizumab in Refractory Mismatch-repair-proficient pMMR or Microsatellite-stable MSS Metastatic Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sequential Immunochemotherapy Treatment With Pembrolizumab Plus Dendritic Cell DC Vaccine Followed by TrifluridineTipiracil FTDTPI Plus Bevacizumab in Refractory Mismatch-repair-proficient pMMR or Microsatellite-stable MSS Metastatic Colorectal Cancer CombiCoR-Vax
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
CombiCoR-Vax
Brief Summary:
Single-arm open-label multicenter phase 2 clinical trial evaluating the clinical and the immunological activity of an innovative strategy with an induction combo immunotherapy Pembrolizumab plus DC Vaccine followed by a maintenance chemotherapy FTDTPI plus Bevacizumab in patients with refractory MSSpMMR metastatic colorectal cancer
Detailed Description:
Metastatic colorectal cancer mCRC remains an incurable disease characterized by a poor prognosis Recently in the global phase 3 SUNLIGHT NCT04737187 study adding Bevacizumab to TrifluridineTipiracil FTDTPI in the treatment of refractory mCRC significantly improved overall survival Therefore this combination regimen is going to become the new standard of care for refractory mCRC Immune checkpoint inhibitors ICIs including Pembrolizumab have shown excellent results in MSI-H or dMMR mCRC and recent trials evaluating both concomitant and sequential chemoimmunotherapy in MSSpMMR mCRC in particular ATEZOTRIBE and MAYA trials have shown promising results Since 2001 we have treated more than 80 advanced melanoma patients with a tumor lysate loaded autologous DC vaccine observing a clinical benefit of 541 and more importantly an ORR of 636 to subsequent chemotherapy suggesting that immunotherapy might improve the activity of sequential chemotherapy Moreover our team has recently concluded the first step of 2 ongoing clinical studies with DC vaccine administration in radically resected mCRC and metastatic mesothelioma patients - showing that the vaccine was safe and promoted immunological responses that allowed it to continue with patients enrollment
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