drugset / Trial / NCT05144529

A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC

NCT05144529

Phase 2 Terminated 19 enrolled Eziafa Oduah, MD, PhD, MPH
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

EvaluationDrugModalityDoseRoute
Subject Evolocumab Monoclonal antibody 14 mg Subcutaneous
Background Ipilimumab Monoclonal antibody 1 mg/kg Intravenous
Background Nivolumab Monoclonal antibody 240 mg Intravenous

Indications