NIPIRESCUE evaluates nivolumab and ipilimumab in patients with MSI/dMMR mCRC resistant to anti-PD1 monotherapy and previously treated with fluoropyrimidine, oxaliplatine, irinotecan, and anti- vascular endothelial growth factor (VEGF) or anti- epidermal growth factor receptor (EGFR) therapy.
Signed and dated patient informed consent form and willingness to comply with all study procedures and availability for the study duration,
Age ≥ 18 years,
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, and 2,
Histologically confirmed colorectal adenocarcinoma,
Known brain metastases or leptomeningeal metastases,
Persistence of toxicities related to prior treatments (chemotherapies or anti-P1 therapies) grade > 1 (NCI CTCAE v 5.0; except dysthyroidism, adrenal gland deficiency, alopecia, fatigue or oxaliplatin-induced peripheral sensory neuropathy which can be ≥ grade 2),
Discontinuation of anti-PD1 treatment due to treatment-related adverse event (AE) grade > 2 (NCI CTCAE v 5.0),
Prior treatment with an anti-LAG-3, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents, except anti-PD1 antibodies,