drugset / Trial / NCT05144529
A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a research study to find out the safety and tolerability of combining the drug evolucumab with standard immunotherapy in people with advanced lung cancer (a type called non-small cell lung cancer). Nivolumab (Opdivo™) and ipilimumab (Yervoy™) are immunotherapy-type drugs which are approved for the treatment of advanced lung cancer that has expression of PD-L1 greater than or equal to 1%. Evolucumab is being combined with nivolumab and ipilimumab to see if it will improve the anti-tumor capabilities of the immunotherapy. Adding evolocumab to the combination of nivolumab and ipilimumab has not been tested in people before and is considered investigational.
Timeline
- Start
- 2022-03-22
- Primary completion
- 2024-09-27
- Completion
- 2024-09-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Evolocumab | Monoclonal antibody | 14 mg | Subcutaneous |
| Background | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Background | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |