PCSK9 mediates immune checkpoint blockade resistance by downregulating tumor cell surface MHC class 1 molecules. This study will evaluate if combining the anti-PCSK9 antibody alirocumab with the anti-PD-1 antibody cemiplimab can generate anti-tumor activity and clinical responses in patients with metastatic lung cancer who have progressed on first line immune checkpoint blockade therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Combination of PCSK9 inhibitor Alirocumab 150mg SC q2weeks and PD-I inhibitor Cemiplimab 350mg IV q3 weeks
Moffitt Cancer Center
Tampa, Florida, United States
Duke University
Durham, North Carolina, United States
Response rate associated with combination of alirocumab and cemiplimab
Ascertain the response rate associated with alirocumab and cemiplimab, with 95% confidence intervals. Response rate is defined as the proportion of treated subjects with a complete or partial response per RECIST 1.1 criteria. All patients who receive at least one dose of alirocumab and cemiplimab will be considered for the primary outcome analysis
Time frame: Day 1 of treatment until the date of first documented progression or date of death, whichever comes first, assessed up to 110 weeks per RECIST 1.1
Safety and tolerability of the combination regimen
Toxicity analysis will be performed on a continual basis following CTC V 5.0 criteria
Time frame: Day 1 of treatment until 30 days post last dose
Progression Free Survival
Progression Free Survival will be assessed utilizing RECIST 1.1 criteria
Time frame: Day 1 of treatment until the date of first documented progression or date of death, whichever comes first, assessed up to 110 weeks
Overall survival
Patients will be followed till death or off study due to any other reason
Time frame: Day 1 of treatment until death or off study due to any other reason whichever comes first, assessed up to 110 weeks
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