Clinical Trial

Sequential Immunochemotherapy Treatment with Pembrolizumab Plus Dendritic Cell (DC) Vaccine Followed by Trifluridine/Tipiracil Plus Bevacizumab in Refractory Mismatch-repair-proficient (pMMR) or Microsatellite-stable (MSS) Metastatic Colorectal Cancer

Study acronym: CombiCoR-Vax
Recruiting Phase 2
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Record status
This record was last updated January 28, 2025 (before its estimated April 1, 2026 completion). Its status may not reflect the trial's current state.
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 (FTD/TPI plus Bevacizumab) in patients with refractory MSS/pMMR metastatic colorectal cancer.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-07-22; most recent amendment 2025-01-24.
Status change: Active, Not Recruiting → Recruiting 2025-01-24
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-01-13
Trial Details
NCT Number NCT06522919
Lead Sponsor Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Conditions Colorectal Cancer Metastatic, Microsatellite Stable Colorectal Carcinoma, Refractory Mismatch-repair-proficient (pMMR) Metastatic Colorectal Cancer
Enrollment 36 participants
Start Date 2025-01-07
Primary Completion 2026-04-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2025-01-28