OncoMatch/Clinical Trials/NCT06522919
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
Is NCT06522919 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Autologous Dendritic Cell (DC) Vaccine for colorectal cancer metastatic.
Treatment: Autologous Dendritic Cell (DC) Vaccine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MSH2 proficient mismatch repair
Histologically confirmed pMMR or MSS mCRC
Required: MSH6 proficient mismatch repair
Histologically confirmed pMMR or MSS mCRC
Required: MLH1 proficient mismatch repair
Histologically confirmed pMMR or MSS mCRC
Required: PMS2 proficient mismatch repair
Histologically confirmed pMMR or MSS mCRC
Required: MSI1 microsatellite stable
Histologically confirmed pMMR or MSS mCRC
Allowed: KRAS wild-type
anti-EGFR monoclonal antibody for RAS wild-type tumors
Allowed: NRAS wild-type
anti-EGFR monoclonal antibody for RAS wild-type tumors
Disease stage
Required: Stage IV
Metastatic disease required
Patients must have measurable disease by RECIST v 1.1 criteria on CT (or MRI) scan of the chest, abdomen and pelvis.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy (fluoropyrimidines, irinotecan, oxaliplatin) — advanced
Prior treatment with 1-2 chemotherapy regimens in an advanced setting, including (if not contraindicated) fluoropyrimidines, irinotecan, oxaliplatin
Must have received: anti-VEGF monoclonal antibody — advanced
including...an anti-VEGF monoclonal antibody
Must have received: anti-EGFR monoclonal antibody — advanced
including...anti-EGFR monoclonal antibody for RAS wild-type tumors
Cannot have received: trifluridine/tipiracil (FTD/TPI)
Prior treatment with FTD/TPI for mCRC
Lab requirements
Blood counts
leukocytes >3,000/μl, absolute neutrophil count >1,500/μl, platelets >100,000/μl
Kidney function
creatinine < 1.5 x uln or creatinine clearance >30 ml/min/1.73 m2
Liver function
total bilirubin < 1.5 x institutional upper limit of normal (uln), ast(sgot)/alt(sgpt) <2.5 x uln
Cardiac function
normal cardiological parameters (12-lead ecg and echocardiogram)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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