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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Eziafa Oduah, MD, PhD, MPH
Study ID
NCT05144529
Phase
PHASE2
Status
Terminated

Conditions

  • Lung Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 22, 2022
Status verified
Apr 2026
Primary completion
Sep 27, 2024
Completion
Sep 27, 2024

Study Design

Enrollment
19 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ipilimumab/nivolumab
    Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks.
  • 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

Primary Outcome Measure

Number of Participants With DLT (Dose-limiting Toxicity) [ Time Frame: Up to 30 days after first study dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Univ. Medical CenterDurhamNorth Carolina27710-

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