Status:
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
Lead Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Conditions:
Colorectal Cancer Metastatic
Microsatellite Stable Colorectal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Metastatic colorectal cancer (mCRC) remains an incurable disease characterized by a poor prognosis. Recently, in the global phase 3 SUNLIGHT (NCT04737187) study, adding Bevacizumab to Trifluridine/Tip...
Eligibility Criteria
Inclusion
- 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 by transfusionist to exclude possible contraindications to leukapheresis; recovered (grade 1 or less by CTCAE 5.0) from all the adverse events related to previous treatments.
Exclusion
- 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.
- 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 \< 1.5 X institutional upper limit of normal (ULN), AST(SGOT)/ALT(SGPT) \<2.5 X ULN, creatinine \< 1.5 X ULN OR creatinine clearance \>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 procedures
- 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 contraceptive method
- Participant is willing and able to give informed consent for participation in the study.
Key Trial Info
Start Date :
January 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06522919
Start Date
January 7 2025
End Date
September 1 2026
Last Update
January 28 2025
Active Locations (2)
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1
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"-IRST S.r.l.
Meldola, Forlì Cesena, Italy, 47014
2
Pia Fondazione di Culto e Religione Azienda Ospedaliera "Card.G.Panico"
Tricase, Lecce, Italy, 73039