RecruitingPhase 2NCT06522919

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

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


Sponsor

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Enrollment

36 participants

Start Date

Jan 7, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a sequence of treatments — immunotherapy (pembrolizumab) plus a personalized dendritic cell vaccine, followed by trifluridine/tipiracil and bevacizumab — for people with metastatic colorectal cancer that has a specific genetic profile (pMMR or MSS) and has not responded to standard chemotherapy. **You may be eligible if...** - You are 18 or older - You have confirmed metastatic colorectal cancer that is pMMR or MSS (a genetic feature meaning it does not respond to standard immunotherapy alone) - You have had 1–2 prior chemotherapy regimens including fluoropyrimidines, irinotecan, oxaliplatin, anti-VEGF, and/or anti-EGFR drugs - You have measurable disease on CT or MRI - Your blood counts and organ function are adequate - A tumor sample was previously collected and sent to the lab for vaccine manufacturing - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You have not completed the required prior chemotherapy regimens - Your tumor sample is not available or does not meet lab acceptance criteria - You have unresolved serious side effects from prior treatments or surgery - You are currently pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAutologous Dendritic Cell (DC) Vaccine

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.


Locations(2)

IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"-IRST S.r.l.

Meldola, Forlì Cesena, Italy

Pia Fondazione di Culto e Religione Azienda Ospedaliera "Card.G.Panico"

Tricase, Lecce, Italy

View Full Details on ClinicalTrials.gov

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NCT06522919


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