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Trial Title:
PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung
NCT ID:
NCT05553834
Condition:
Non-small Cell Lung Cancer (NSCLC)
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Cemiplimab
Alirocumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Combination therapy involving anti-PCSK9 antibody alirocumab with the anti-PD-1 antibody
cemiplimab.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Alirocumab and Cemiplimab
Description:
Combination of PCSK9 inhibitor Alirocumab 150mg SC q2weeks and PD-I inhibitor Cemiplimab
350mg IV q3 weeks
Arm group label:
Alirocumab and Cemiplimab
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically documented recurrent and/or metastatic non-small cell lung cancer
- Progression after prior PD-1 directed therapy (as monotherapy or in combination with
chemotherapy and/or anti-CTLA4, or anti-VEGF agents) - defined as investigator
assessed progression from prior treatment
- If molecularly altered NSCLC including EGFR, ALK, ROS1, MET exon 14, RET, BRAF,
NTRK, progression on prior targeted therapy is required
- Measurable disease by RECIST 1.1
- ECOG Performance Status 0 or 1
- Signed written informed consent
- Minimum of 4 weeks from any other experimental anti-cancer therapies or prior PD-1
treatment
- Meet all the laboratory criteria per protocol
Exclusion Criteria:
- Prior treatment with PCSK9 inhibitors
- Cardiac issues including MI, uncontrolled arrhythmia, symptomatic angina pectoris,
active ischemia, or cardiac failure not controlled by medications.
- Uncontrolled diabetes mellitus, defined as HbA1c > 10
- Major surgery less than 4 weeks prior to study enrollment
- Another malignant condition diagnosed within 3 years of study enrollment
- Intolerance to prior PD-1/L1 treatment including discontinuation for severe or
recurrent severe toxicity (including myocarditis or other myocardiotoxity,
encephalitis, colitis, diarrhea, pancreatitis, hypo/hyperthyroidism,
hypopituitarism, adrenal insufficiency, rash, autonomic neuropathy, myasthenia
gravis, Guillain-Barre, myositis/polymyositis, hepatitis, Type 1 Diabetes,
thrombocytopenia) or developed an immune checkpoint blockade related immune adverse
event that was refractory to steroids and required additional systemic
immunosuppressive medication.
- Known history of HIV seropositivity or known acquired immunodeficiency syndrome
(AIDS)
- Additional exclusion criterion as per listed in the protocol
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anahid Aminpour
Phone:
813-745-0287
Email:
Anahid.Aminpour@moffitt.org
Facility:
Name:
Duke University
Address:
City:
Durham
Zip:
27705
Country:
United States
Status:
Recruiting
Contact:
Last name:
Scott Antonia, MD
Contact backup:
Last name:
Monika Anand, PhD
Start date:
May 16, 2023
Completion date:
January 1, 2029
Lead sponsor:
Agency:
Duke University
Agency class:
Other
Collaborator:
Agency:
Regeneron Pharmaceuticals
Agency class:
Industry
Source:
Duke University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05553834
