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

Recruiting Phase 2 Interventional Study
Colorectal Cancer Metastatic Microsatellite Stable Colorectal Carcinoma Refractory Mismatch-repair-proficient (pMMR) Metastatic Colorectal Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Other
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 * ECOG performance status \<2 * Patient suitable for the collection of biological material from leukap…
Contacts

Oriana Nanni

0543739266

oriana.nanni@irst.emr.it

CONTACT

Bernadette Vertogen

0544286058

bernadette.vertogen@irst.emr.it

CONTACT