OncoMatch/Clinical Trials/NCT07328087
COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer
Is NCT07328087 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Experimental: COLONYVAQ-CRC + mFOLFOX6 or CAPOX + Nivolumab for colorectal cancer metastatic.
Treatment: Experimental: COLONYVAQ-CRC + mFOLFOX6 or CAPOX + Nivolumab — This is an early phase I, single-arm, open-label clinical study designed to evaluate the safety, tolerability, and feasibility of COLONYVAQ-CRC, a physics-aware, quantum-classical AI-guided personalized neoantigen peptide vaccine, administered in combination with standard adjuvant oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX) and nivolumab 3 mg/kg in patients with completely resected stage III microsatellite-stable (MSS) / proficient mismatch repair (pMMR) colorectal cancer. An initial safety cohort of 12 patients will be enrolled and closely monitored for toxicity attributable to the experimental vaccine preparation. If, among these 12 patients, fewer than 3 develop experimental-preparation-related toxicity greater than grade 2 and no patient develops experimental-preparation-related grade 4 toxicity, the study will expand to enroll a total of 50 patients. Primary objectives focus on safety and tolerability of the combination regimen. Secondary and exploratory objectives characterize neoantigen-specific immune responses, ctDNA dynamics, T-cell receptor (TCR) clonotype evolution, tumor immune microenvironment features, and preliminary disease control (disease-free survival and overall survival) to inform subsequent phase II design.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MLH1 wild-type
Tumor confirmed MSS or pMMR by local testing using one or more of the following: IHC for MLH1, MSH2, MSH6, and PMS2
Required: MSH2 wild-type
Tumor confirmed MSS or pMMR by local testing using one or more of the following: IHC for MLH1, MSH2, MSH6, and PMS2
Required: MSH6 wild-type
Tumor confirmed MSS or pMMR by local testing using one or more of the following: IHC for MLH1, MSH2, MSH6, and PMS2
Required: PMS2 wild-type
Tumor confirmed MSS or pMMR by local testing using one or more of the following: IHC for MLH1, MSH2, MSH6, and PMS2
Disease stage
Required: Stage III (AJCC 8th edition)
Excluded: Stage IV
Pathologic stage III disease (any T, N1-2, M0) per AJCC 8th edition.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgery — R0 resection
R0 resection of the primary tumor documented by operative and pathology reports (no macroscopic or microscopic residual tumor at margins).
Cannot have received: systemic therapy for metastatic CRC
Prior systemic therapy for metastatic CRC.
Cannot have received: tumor vaccine targeting TAAs or neoantigens
Prior tumor vaccine targeting TAAs or neoantigens (peptide, DC, viral, RNA, or DNA).
Cannot have received: immune checkpoint inhibitor therapy
Prior immune checkpoint inhibitor therapy (anti-PD-1, anti-PD-L1, anti-CTLA-4).
Lab requirements
Blood counts
anc ≥ 1.5 × 10⁹/l; platelets ≥ 100 × 10⁹/l; hemoglobin ≥ 9.0 g/dl (transfusions allowed if clinically indicated, but not solely to qualify)
Kidney function
serum creatinine ≤ 1.5 × uln or creatinine clearance ≥ 50 ml/min (cockcroft-gault or institutional standard)
Liver function
total bilirubin ≤ 1.5 × uln (≤3 × uln allowed for known gilbert's syndrome if direct bilirubin is normal); ast and alt ≤ 2.5 × uln; alkaline phosphatase ≤ 2.5 × uln (higher thresholds may be allowed for non-malignant causes per protocol)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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