Perioperative/Adjuvant atezolizumab in patients with MSI-high or MMRdeficient stage II high risk or stage III colorectal cancer ineligible for oxaliplatin-based chemotherapy– a Phase II study (ANTONIO)

Patients with MSI-high or MMR-deficient stage III colorectal cancer who are ineligible for or who refuse oxaliplatin-based chemotherapy after R0 tumor resection (main study) or planned resection (sub-study)

The primary efficacy endpoint is disease-free survival (DFS) rate at 3 years, defined as the proportion of patients without relapse or tumor-related death from any cause 3 years after start of treatment in the intention-to-treat population., For the sub-study: Pathological complete (pCR) or subtotal (<10% vital tumor cells) regression (measured in resected tumors) after completion of 5 weeks of neoadjuvant treatment., incidence, severity and causality/ relationship of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI)

DFS including 1-, and 2-year tumor-specific DFS rates, Overall Survival (OS) including 1-, 2- and 3-year OS rates, Rate of patients without detectable ctDNA after 12 months. ctDNA-free is defined as a ctDNA level below the lowest limit of detection of the respective Liquid Biopsy Assay, QoL

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