Actively Recruiting
COLONYVAQ-CRC Personalized Neoantigen Peptide Vaccine Combined With Standard Adjuvant Chemotherapy and Nivolumab in Completely Resected Stage III Microsatellite-Stable Colorectal Cancer
Led by Biogenea Pharmaceuticals Ltd. · Updated on 2026-01-09
12
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
B
Biogenea Pharmaceuticals Ltd.
Lead Sponsor
I
Interbalkan Medical Center, Thessaloniki, Greece
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating COLONYVAQ-CRC, a personalized neoantigen peptide vaccine using a physics-aware, quantum-classical AI-guided system, combined with standard oxaliplatin-based chemotherapy and nivolumab in patients with completely resected stage III microsatellite-stable colorectal cancer. This early phase I, single-arm, open-label study aims to assess the safety, tolerability, and feasibility of this combination treatment, while also exploring immune response and preliminary disease control. The study includes an initial safety cohort followed by an expansion phase if safety criteria are met. All participants receive the COLONYVAQ-CRC vaccine, consisting of up to 20 personalized peptides selected through advanced quantum-classical methods and mixed with an immune-stimulating agent for subcutaneous injection on a prime-boost schedule. This vaccine is given alongside standard adjuvant chemotherapy (either mFOLFOX6 every 14 days for about 6 months or CAPOX every 21 days for 3 to 6 months) and nivolumab infusions every 2 weeks for up to 12 months. The combination is designed to enhance immune activation by increasing tumor antigen presentation and supporting T-cell function. Participants will be closely monitored throughout the study for treatment-related side effects and immune responses over approximately 12 months. Assessments include blood samples for circulating tumor DNA and immune monitoring, imaging to check for cancer recurrence, quality of life questionnaires, and analysis of tumor immune environment. Follow-up extends up to 5 years for overall survival evaluation, with comprehensive safety and feasibility data collected to guide future research.
CONDITIONS
Brief Title
COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the colon or rectum
- Pathologic stage III disease with R0 resection (complete tumor removal) and no distant metastases
- Tumor confirmed as microsatellite stable (MSS) or proficient mismatch repair (pMMR)
- At least one high-risk feature such as T4 tumor, N2 nodal status, or positive postoperative circulating tumor DNA
- Eligible for adjuvant oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX) and nivolumab treatment
- ECOG performance status of 0 or 1
- Adequate blood, liver, and kidney function within 14 days prior to enrollment
- Available tumor tissue and matched normal sample for sequencing
- At least one predicted high-quality tumor neoantigen identified by the COLONYVAQ pipeline
- Life expectancy estimated to be 3 years or more without cancer recurrence
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception
- Men with partners of childbearing potential must agree to use effective contraception
- Able to understand and voluntarily sign informed consent and comply with study procedures
You will not qualify if you...
- Residual or metastatic disease at baseline including R2 resection or distant metastases
- Known mismatch repair-deficient, MSI-high, or POLE-ultramutated colorectal cancer
- Prior systemic therapy for metastatic colorectal cancer or prior immune checkpoint inhibitor therapy
- Active infections requiring systemic treatment or uncontrolled HIV or hepatitis
- Severe or uncontrolled autoimmune disease requiring systemic immunosuppression
- Prior allogeneic stem cell or solid organ transplantation
- Severe hypersensitivity to vaccine components, chemotherapy agents, or nivolumab
- Active second primary malignancy requiring systemic therapy except certain treated cancers
- Significant unstable cardiovascular or pulmonary disease
- Pregnant or breastfeeding women
- Participation in another interventional trial with systemic agents that could interfere
- Psychiatric or social conditions limiting study compliance or impacting safety or data interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive a personalized neoantigen peptide vaccine combined with standard adjuvant chemotherapy and nivolumab. The vaccine is given by subcutaneous injection in a prime-boost schedule coordinated with chemotherapy. Chemotherapy is given with either mFOLFOX6 every 2 weeks for about 6 months or CAPOX every 3 weeks for about 3 to 6 months. Nivolumab is administered intravenously every 2 weeks for up to 12 months.
Multiple visits for vaccine administration and chemotherapy: vaccine doses on Days 1, 4, 8, 15, 22, and booster doses around Weeks 12 and 20; chemotherapy visits every 2 or 3 weeks depending on regimen; nivolumab every 2 weeks
Duration - Up to 60 months
Participants are monitored for safety, immune response, and disease status after treatment completion.
Visits at 12 months and annually up to 36 months, with additional assessments as scheduled
Trial Site Locations
Total: 1 location
1
Biogenea Pharmaeuticals Ltd
Thessaloniki, Greece, 54627
Actively Recruiting
Research Team
I
Ioannis Grigoriadis, PharmacistPharmD
C
Christos Emmanouelides, MD, PhD, Medical Oncologist,
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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