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 (Jun 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 Jun 2026Location: Italy

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.

Check if I qualify

Extracted eligibility criteria

Treatments studied

Other

Autologous Dendritic Cell (DC) Vaccine

Cancer type

Colorectal Cancer

Biomarker criteria

Required: MSI1 microsatellite stable

Histologically confirmed pMMR or MSS mCRC

Required: Mismatch-repair proficient (pMMR / MSS)

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.

Frequently asked questions

Is NCT06522919 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior trifluridine/tipiracil disqualifies patients from enrollment.

Does this trial require MSH2?

Yes, MSH2 proficient mismatch repair is a required biomarker for enrollment.

Does this trial require MSH6?

Yes, MSH6 proficient mismatch repair is a required biomarker for enrollment.

Does this trial require MLH1?

Yes, MLH1 proficient mismatch repair is a required biomarker for enrollment.

What disease stage is eligible?

Stage IV is required (metastatic disease required).

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify