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,
Single group
Nivolumab
DrugInduction therapy with nivolumab 240 mg; 4 infusions, every 3 weeks. Maintenance therapy with nivolumab 480 mg; 21 infusions, every 4 weeks.
Ipilimumab
DrugInduction therapy with ipilimumab 1 mg/kg; 4 infusions, every 3 weeks.
Objective response rate (ORR) by RECIST 1.1
ORR defined as the number of patients with partial or complete response from the beginning of the treatment divided by the total of number of patients evaluable for the primary endpoint analysis.
Number of participants with treatment-related adverse events
All grade and severe toxicities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Disease control rate (DCR)
DCR by RECIST 1.1 is defined as the percentage of patients who achieve complete response, partial response, or stable disease after study treatment.
Duration of response
Duration of response is measured from the time of the first response observed (partial or complete) until documented tumor progression or death.
Progression-free survival (PFS)
PFS by RECIST 1.1 is defined as time from beginning of treatment to progression or death due to any cause, whichever occurs first. Death event will be assessed until the initiation of the subsequent anti-cancer therapy.
Click on the lead sponsor to view all of their trials.
