Actively Recruiting
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
Led by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Updated on 2025-01-28
36
Participants Needed
2
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Histologically confirmed pMMR or MSS metastatic colorectal cancer
- Male or female aged 18 years or older
- Life expectancy greater than 12 weeks
- ECOG performance status less than 2
- Suitable for leukapheresis with negative HIV, HBV, HCV, and Treponema pallidum tests
- Normal heart function based on ECG and echocardiogram
- Recovered from previous treatment side effects to grade 1 or less by CTCAE 5.0
- For females of childbearing potential and all males: agreement to use effective contraception
- Recovered from adverse events related to previous surgery to grade 1 or less by CTCAE 5.0
You will not qualify if you...
- Prior treatment with FTD/TPI for metastatic colorectal cancer
- Chemotherapy or radiotherapy within 4 weeks before study or unresolved side effects from treatments given more than 4 weeks earlier
- Participation in another clinical trial with investigational agents within 30 days before screening
- Known brain metastases
- Allergic reactions to Pembrolizumab, FTD/TPI, Bevacizumab, or components of the dendritic cell vaccine
- History of congenital or acquired immunodeficiency, including organ transplantation
- Active inflammatory or autoimmune diseases needing systemic steroids or immunomodulators
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting compliance
- Other malignancies in medical history with less than 5 years disease-free interval, except treated basal cell carcinoma or in situ cervical carcinoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"-IRST S.r.l.
Meldola, Forlì Cesena, Italy, 47014
Actively Recruiting
2
Pia Fondazione di Culto e Religione Azienda Ospedaliera "Card.G.Panico"
Tricase, Lecce, Italy, 73039
Not Yet Recruiting
Research Team
O
Oriana Nanni
CONTACT
B
Bernadette Vertogen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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