OncoMatch/Clinical Trials/NCT05845450
Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)
Is NCT05845450 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
Other
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.
Frequently asked questions
Is NCT05845450 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require MMR?
Yes, MMR proficient is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require POLE?
Yes, POLE proofread domain mutation associated with ultra-mutated status is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify