Adjuvant therapy in stage IV colorectal cancer patients NED

Prior treatment

• Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment
• Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable

Other illness

• Any form of systemic disease that, in the opinion of the Investigator, would make the subject unsuitable for the study (including autoimmunity) or would prevent compliance with the study protocol

Lab values

• Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria

Other

• Patients with microsatellite instability (MSI) or DNA Mismatch Repair Deficiency (dMMR) are not allowed

• ≥ 18 years
• Histologically confirmed diagnosis of colorectal adenocarcinoma
• Patients must be in NED after completion of any treatments for stage IV CRC, including resections, RFA; RT with or without neoadjuvant/adjuvant therapies or CR after chemotherapy
• NED state ascertained by means of CT scan and/or PET scan and/or MRI scan
• Patients must be randomized within 10 weeks since the achievement of the NED state. Those who have also received adjuvant therapy following the locoregional treatment or those who achieved complete response on systemic therapies are still eligible, provided they are randomized within 4 weeks since the last chemotherapy cycle