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.

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• General exclusion criteria for the study population Patients meeting any of the following criteria will be excluded from the study: • Distant metastases at any site. • Risk criteria for obstructing disease at radiology or endoscopy as defined in the pivotal FOxTROT study (see Section 5.1.1). • 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. • Previous or concurrent malignancy within 2 years of study entry. • Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following: history of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft, coronary angioplasty or stenting) ≤ 6 months prior to start of study treatment; symptomatic congestive heart failure (i.e., Grade 2 or higher), history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality ≤ 6 months prior to start of study treatment, except atrial fibrillation and paroxysmal supraventricular tachycardia. • Known history of HIV infection. • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible only in case of negativity of HBV DNA. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. • Other severe acute or chronic diseases that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient an inappropriate candidate for the study. • Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with trial requirements. • Women in pregnancy or lactation condition. Women with child-bearing potential or sexually-active men not willing to use adequate contraception during whole study period. • Use of any disallowed drug, as explained in Section 9.2, that cannot be suspended ≤ 1 week before study treatment start.