Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)
Window-of-opportunity Umbrella Platform Trial of Short-course Pre-operative Targeted Treatments in Patients With Molecularly Selected and Resectable Primary Colorectal Cancer: the UNICORN Study
Gruppo Oncologico del Nord-Ovest
197 participants
May 11, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
trastuzumab deruxtecan 5.4 mg/kg IV on day 1
durvalumab 1500 mg IV on day 1
panitumumab 6 mg/kg IV on days 1 and 15
botensilimab 1 mg/kg on day 1
balstilimab 3 mg/Kg on days 1 and 15
sotorasib 960 mg orally once daily from day 1 to 28
vorbipiprant 90 mg orally bid from day 1 to 28
240 mg IV on days 1 and 15
amivantamab at the dose of 1600 mg (2240 mg if body weight ≥ 80 Kg), subcutaneously, on days 1, 8, 15 and 22
Botensilimab at the dose of 75 mg, IV on day 1
balstilimab at the dose of 240 mg, IV on days 1, 15, 29 and 43
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05845450