The purpose of this study is to examine the safety and efficacy of combining Nivolumab and low-dose Oxaliplatin with or without Ipilumumab in patients who have had their advanced NSCLC cancer worsen on or after being treated with certain immunotherapies (drugs that target the immune system).
The purpose of this study is to examine the safety and efficacy of combining Nivolumab and low-dose Oxaliplatin with or without Ipilumumab in patients who have had their advanced NSCLC cancer worsen on or after being treated with certain immunotherapies (drugs that target the immune system). Nivolumab (Opdivo®) is approved by the Food and Drug Administration (FDA) for the treatment of metastatic (the cancer has spread) NSCLC. It is a type of drug called a monoclonal antibody (a type of protein). Monoclonal antibodies bind to other proteins, such as PD-1 (programmed cell death-1), on immune cells, which allows the immune cells to continue working against the tumor. Ipilumumab (Yervoy®) is also a monoclonal antibody, but binds to a protein called CTLA-4 (cytotoxic T-lymphocyte-associated protein 4). Oxaliplatin is a type of immunogenic chemotherapy, which may increase the body's immune response to the cancer. Both are approved for treatment of other types of cancers, but not in patients with NSCLC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
240 mg every 2 weeks. Nivolumab will continue for up to 2 years.
65 mg/m2 every 2 weeks. Oxaliplatin will continue for up to 12 cycles.
1 mg/kg every 6 weeks. Ipilimumab will continue for up to 4 cycles
UC San Diego Moores Cancer Center
La Jolla, California, United States
Objective response rate (ORR)
To estimate ORR by RECIST 1.1
Time frame: 4 months
Overall survival (OS)
Overall survival (OS)
Time frame: 1 and 2 year
Progression-free survival (PFS)
Progression-free survival (PFS)
Time frame: 1 year
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