MedTrace Logo

Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)

NCT05845450 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2026-03-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Trastuzumab deruxtecan

trastuzumab deruxtecan 5.4 mg/kg IV on day 1

DRUG

Durvalumab

durvalumab 1500 mg IV on day 1

DRUG

Panitumumab

panitumumab 6 mg/kg IV on days 1 and 15

DRUG

Botensilimab

botensilimab 1 mg/kg on day 1

DRUG

Balstilimab

balstilimab 3 mg/Kg on days 1 and 15

DRUG

Sotorasib

sotorasib 960 mg orally once daily from day 1 to 28

DRUG

Vorbipiprant

vorbipiprant 90 mg orally bid from day 1 to 28

DRUG

Nivolumab

240 mg IV on days 1 and 15

DRUG

Amivantamab

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

DRUG

Botensilimab

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

DRUG

Balstilimab

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

Sponsors & Collaborators

  • Gruppo Oncologico del Nord-Ovest

    lead OTHER

Principal Investigators

  • Filippo Pietrantonio, MD · Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-11
Primary Completion
2026-05-31
Completion
2028-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05845450 on ClinicalTrials.gov