Adjuvant Durvalumab Plus Regorafenib vs Untreated Control in Stage IV Colorectal Cancer Patients With no Evidence of Disease (NED): VIVA Trial

Inclusion Criteria:

1. ≥ 18 years; ECOG PS 0-1;
2. Body weight \>30 kg;
3. Histologically confirmed diagnosis of colorectal adenocarcinoma;
4. 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;
5. 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 are still eligible, provided they are randomized within 4 weeks since the last chemotherapy cycle;
6. NED state ascertained by means of CT scan and/or PET scan and/or MRI scan;
7. Life expectancy of at least 12 weeks;
8. CEA within normal limits;
9. No residual toxicity from previous chemotherapy;
10. Adequate organ function;

Exclusion criteria:

1. MSI/dMMR patients;
2. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia and vitiligo;
3. Active or prior documented autoimmune or inflammatory disorders;
4. Relevant concomitant comorbidities;