Phase I/II Study of Nivolumab and Ipilimumab combined with Nintedanib in Non Small Cell Lung Cancer
The main purpose of this study is to see if the combination of nivolumab, ipilimumab and nintedanib is effective in people with non- small cell lung cancer. Researchers also want to find out if the combination of nivolumab, ipilimumab and nintedanib is safe and tolerable.
Phase I (Dose Escalation): Determine the MTD and RP2D of concurrent administration of nivolumab, ipilimumab, and nintedanib. Phase II (Single Arm Cohorts): To determine the efficacy of concurrent administration of nivolumab, ipilimumab, and nintedanib in NSCLC patients. (1) Arm A: Newly diagnosed or treatment-naïve patients, with a target ORR of 50%, or (2) Arm B: Patients who have been previously exposed to immunotherapy, such as anti-PD-1, anti-PD-L1 or anti-CTLA-4, with a target ORR of 20%.
Immunotherapy; Therapy (NOS)
BMS-936558 (Nivolumab); Ipilimumab (); Nintedanib (); Nivolumab (Opdivo); Yervoy (Ipilimumab)
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