OncoMatch/Clinical Trials/NCT05845450
Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)
Is NCT05845450 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for colorectal cancer.
Treatment: Trastuzumab deruxtecan · Durvalumab · Panitumumab · Botensilimab · Balstilimab · Sotorasib · Vorbipiprant · Nivolumab · Amivantamab · Botensilimab · Balstilimab — This is a window-of-opportunity umbrella platform trial enrolling non-metastatic resectable colorectal patients selected for the presence of a specific targetable molecular alteration. The study aims to test the activity of specific targeted agents/combinations given as a short-course pre-operative strategy, matched with the specific alteration detected, followed by standard of care surgery.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MMR proficient (pMMR/MSS)
pMMR/MSS status
Required: HER2 (ERBB2) overexpression (positive)
HER2-positive status
Required: POLE proofread domain mutation associated with ultra-mutated status (tumor mutational burden >100 Mut/Mb)
Proofread domain mutations in POLE or POLD1 associated with ultra-mutated status, i.e. tumor mutational burden >100 Mut/Mb.
Required: POLD1 proofread domain mutation associated with ultra-mutated status (tumor mutational burden >100 Mut/Mb)
Proofread domain mutations in POLE or POLD1 associated with ultra-mutated status, i.e. tumor mutational burden >100 Mut/Mb.
Required: RAS wild-type
wild-type status for RAS
Required: BRAF wild-type
wild-type status for BRAF
Required: HER2 (ERBB2) overexpression/amplification (absent)
absence of HER2 overexpression/amplification
Required: POLE proofread domain pathogenic mutation associated with ultra-mutated status (absent)
absence of POLE/D1 proof-read domain pathogenic mutation associated with ultra-mutated status
Required: POLD1 proofread domain pathogenic mutation associated with ultra-mutated status (absent)
absence of POLE/D1 proof-read domain pathogenic mutation associated with ultra-mutated status
Required: KRAS G12C
KRAS G12C mutation
Required: KRAS G12C (absent)
absence of KRAS G12C mutation
Required: MMR deficient (dMMR/MSI-H)
dMMR/MSI-H status
Disease stage
Excluded: Stage DISTANT METASTASES
Radiological stage cT3-4, N0-2, M0 using computed tomography (CT) as in the pivotal FOxTROT study.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic treatment
No prior systemic treatment for colorectal cancer
Cannot have received: neoadjuvant radiation therapy
No prior ... neoadjuvant radiation therapy for rectal cancer
Lab requirements
Blood counts
absolute neutrophil count ≥ 1.5 × 10^9/L; platelet count ≥ 100 × 10^9/L; hemoglobin ≥ 9.0 g/dL
Kidney function
serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min
Liver function
serum total bilirubin ≤ 1.5 × ULN and < 2 mg/dL; indirect bilirubin ≤ 1.5 × ULN if total bilirubin > 1.5 × ULN; ALT and/or AST ≤ 2.5 × ULN
Adequate bone marrow function (absolute neutrophil count ≥ 1.5 × 10^9/L; platelet count ≥ 100 × 10^9/L; hemoglobin ≥ 9.0 g/dL) Adequate renal function characterized by serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated by Cockroft-Gault formula or directly measured creatinine clearance ≥ 50 mL/min at screening. Adequate hepatic function (serum total bilirubin ≤ 1.5 × ULN and < 2 mg/dL. Note: Patients who have a total bilirubin level 1.5 × ULN will be allowed if their indirect bilirubin level is ≤ 1.5 × ULN; Alanine aminotransferase and/or aspartate aminotransferase ≤ 2.5 × ULN).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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