Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGruppo Oncologico del Nord-Ovest
About this trial
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 criteria
Qualifiers
Provide a signed and dated informed consent document.
Age ≥ 18 years at time of informed consent.
ECOG PS of 0 and 1.
Histologically confirmed colorectal cancer adenocarcinoma that is judged as initially resectable with elective surgery aimed at radical intent with R0 margins as per multidisciplinary team assessment.
Disqualifiers
Distant metastases at any site, as defined by negativity of chest/abdomen/pelvis contrast-enhanced computed tomography (CT).
Risk criteria for obstructing disease at radiology or endoscopy as defined in the pivotal FOxTROT study.
Need to receive neoadjuvant radiation or chemoradiation in patients with rectal cancer.
Patients with known hypersensitivity to the study drug of the assigned cohort or to its excipients or to drugs belonging to the same drug class.
Trial design
Treatments tested in this trial
- Trastuzumab deruxtecan
- Durvalumab
- Panitumumab
- Botensilimab
- Balstilimab
- Sotorasib
- Vorbipiprant
- Nivolumab
- Amivantamab
- Botensilimab
- Balstilimab
Treatment groups
197 Participants
are divided into 13 treatment groups13
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov