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New treatment option for Colorectal Cancer Metastatic
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
ClinicalTrials.gov ID: NCT06522919
What this study is testing
What is Autologous Dendritic Cell (DC) Vaccine?
Autologous Dendritic Cell (DC) Vaccine is an investigational medicine, being studied as a potential treatment for colorectal cancer metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Prior treatment with 1-2 chemotherapy regimens in an advanced setting, including (if not contraindicated) fluoropyrimidines, irinotecan, oxaliplatin...
- Patients must have normal organ and marrow function as defined below: leukocytes \>3,000/μL, absolute neutrophil count \>1,500/μL, platelets...
- The autologous surgical specimen needed for vaccine manufacturing must have been collected and sent to the Somatic Cell Therapy Lab of IRCCS IRST and...
- Recovery (grade 1 or less by CTCAE 5.0) from all the adverse events related to previous surgery.
- A female participant is eligible to participate if she is not pregnant and not breastfeeding. Female patients of childbearing potential and all male...
See the full eligibility 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 leukapheresis: negative serological tests (HIV, HBV, HCV, Treponema pallidum); normal cardiological parameters (12-lead ECG and echocardiogram); evaluation...
- 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...
- Patients must have normal organ and marrow function as defined below: leukocytes \>3,000/μL, absolute neutrophil count \>1,500/μL, platelets \>100,000/μL, total bilirubin \ 30 mL/min/1.73 m2
- 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...
- Recovery (grade 1 or less by CTCAE 5.0) from all the adverse events related to previous surgery.
- A female participant is eligible to participate if she is not pregnant and not breastfeeding. Female patients of childbearing potential and all male patients must accept and be compliant with a highly effective...
- Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria: The participant may not enter the study if ANY of the following apply:
- Prior treatment with FTD/TPI for mCRC
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pembrolizumab, FTD/TPI, Bevacizumab or components of the DC vaccine.
- History of congenital or acquired immunodeficiency, including history of organ transplantation.
- Any active inflammatory or autoimmune disease requiring systemic steroids or other immunomodulatory agents
- Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine...
The study team makes the final eligibility decision.
Where it's taking place
- Meldola, Forlì Cesena, Italy
- Tricase, Lecce, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Meldola, Forlì Cesena, Italy; Tricase, Lecce, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.