Health Trials

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

ConditionsColorectal Cancer MetastaticMicrosatellite Stable Colorectal CarcinomaRefractory Mismatch-repair-proficient (pMMR) Metastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

About this trial

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 criteria

Qualifiers

Be willing and able to provide written informed consent.

Histologically confirmed pMMR or MSS mCRC

Male or female, aged ≥ 18 years

Life expectancy greater than 12 weeks

Disqualifiers

Patients must have measurable disease by RECIST v 1.1 criteria on CT (or MRI) scan of the chest, abdomen and pelvis. See section 9.2 and Appendix D for the evaluation of measurable disease.

Prior treatment with 1-2 chemotherapy regimens in an advanced setting, including (if not contraindicated) fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and/or anti-EGFR monoclonal antibody for RAS wild-type tumors.

The autologous surgical specimen needed for vaccine manufacturing must have been collected and sent to the Somatic Cell Therapy Lab of IRCCS IRST and must fulfill all the acceptance criteria prescribed by the GMP procedures

Recovery (grade 1 or less by CTCAE 5.0) from all the adverse events related to previous surgery.

Trial design

Treatments tested in this trial

  • Autologous Dendritic Cell (DC) Vaccine

Treatment groups

36 Participants
are divided into 1 treatment group

Sponsors and collaborators

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

Lead sponsor

Source ClinicalTrials.gov