OncoMatch

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.

Phase 2RecruitingIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSNCT06522919Data as of May 2026

Treatment: Autologous Dendritic Cell (DC) VaccineSingle-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.

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Extracted 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

Max 2 prior lines
Min 1 prior line

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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