Scott Antonia
Scott Antonia
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.
Lung Cancer Metastatic
Nivolumab
Ipilimumab
Evolocumab
Phase 2
Study Type : | Interventional |
Estimated Enrollment : | 38 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | A Randomized Pilot Study to Investigate the Safety and Immunologic Impact of Evolocumab When Given in Combination With Ipilimumab and Nivolumab in Treatment-Naïve Patients With Metastatic Non-Small Cell Lung Cancer |
Actual Study Start Date : | March 22, 2022 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | December 2025 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Ipilimumab/nivolumab Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks. |
Drug: Nivolumab Drug: Ipilimumab |
Experimental: ipilimumab/nivolumab/evolucumab Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks plus evolocumab 140 mg SC every 2 weeks |
Drug: Nivolumab Drug: Ipilimumab |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Duke Univ. Medical Center
Durham, North Carolina, United States, 27710