RecruitingPhase 2NCT05845450

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


Sponsor

Gruppo Oncologico del Nord-Ovest

Enrollment

197 participants

Start Date

May 11, 2023

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving patients targeted treatments before surgery — based on the specific genetic makeup of their colorectal cancer — can improve outcomes. Rather than a one-size-fits-all approach, treatment is matched to specific gene mutations found in the tumor. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of colorectal cancer that can be surgically removed - Your cancer has a specific genetic mutation (such as BRAF, RAS, HER2, MSI, NTRK, or others) that matches one of the study treatments - You are in good general health (able to carry out daily activities) - You have not yet received treatment for this cancer **You may NOT be eligible if...** - You have already had chemotherapy or radiation for this cancer - Your cancer has spread to distant organs and is not removable - You have a serious heart condition, active infections, or other major health issues - You are pregnant or breastfeeding - You have had certain other cancers in the past 3 years Talk to your doctor to see if this trial is right for you.

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

DRUGTrastuzumab deruxtecan

trastuzumab deruxtecan 5.4 mg/kg IV on day 1

DRUGDurvalumab

durvalumab 1500 mg IV on day 1

DRUGPanitumumab

panitumumab 6 mg/kg IV on days 1 and 15

DRUGBotensilimab

botensilimab 1 mg/kg on day 1

DRUGBalstilimab

balstilimab 3 mg/Kg on days 1 and 15

DRUGSotorasib

sotorasib 960 mg orally once daily from day 1 to 28

DRUGVorbipiprant

vorbipiprant 90 mg orally bid from day 1 to 28

DRUGNivolumab

240 mg IV on days 1 and 15

DRUGAmivantamab

amivantamab at the dose of 1600 mg (2240 mg if body weight ≥ 80 Kg), subcutaneously, on days 1, 8, 15 and 22

DRUGBotensilimab

Botensilimab at the dose of 75 mg, IV on day 1

DRUGBalstilimab

balstilimab at the dose of 240 mg, IV on days 1, 15, 29 and 43


Locations(1)

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, Lombardia/MI, Italy

View Full Details on ClinicalTrials.gov

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NCT05845450


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