Clinical Trial 21158

• Overview

  Study Title:

  A Phase II Study of PCSK9 Inhibitor Alirocumab and PD-1 Inhibitor Cemiplimab in Patients with Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung Cancer

  Objective:

  Primary Objective * To study the clinical activity (response rate as assessed by RECIST 1.1) of PCSK-9 inhibitor alirocumab in combination with cemiplimab in patients with locally advanced or metastatic non-small cell lung cancer who have progressed on prior therapy with an anti-PD1/L1 agent. Secondary Objectives * To evaluate the safety and tolerability of the combination regimen. * To evaluate secondary efficacy endpoints of the combination regimen.

• Treatments

  Therapies:

  Immunotherapy

  Medications:

  Alirocumab (); Cemiplimab (); REGN2810 (Cemiplimab)

• Inclusion Criteria

  Inclusion Criteria:
  • Histologically and/or cytologically documented recurrent and/or metastatic stage IV non small cell lung cancer (NSCLC)
  • Progression after prior PD-1/PDL1 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 (see Appendix A). Tumor lesions in a previously irradiated area are considered measurable IF progression has been demonstrated in such lesions after radiation.
  • ECOG Performance Status 0 or 1
  • Minimum of 4 weeks from any anti-cancer therapies or prior PD-1 treatment.
  • 18 years of age or older
  • Signed written informed consent including HIPAA according to institutional guidelines.
  • Other criteria may apply

• Exclusion Criteria

  Exclusion Criteria:
  • Prior treatment with PCSK9 inhibitors.
  • Myocardial infarction having occurred less than 6 months prior to study enrollment, any known uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia, or cardiac failure not controlled by medications. Patients with CAD recently treated with surgery and/or stent greater than 6 months prior to enrollment, and if stable without symptomatic angina pectoris, or active ischemia are eligible.
  • Uncontrolled diabetes mellitus, defined as HbA1c > 8.5.
  • Major surgery less than 4 weeks prior to study enrollment.
  • Known history of HIV seropositivity or known acquired immunodeficiency syndrome (AIDS).
  • Another malignant condition diagnosed within 3 years of study enrollment. Exceptions include non-invasive superficial cancers including squamous cell in situ of skin, Stage 0 ductal carcinoma in situ of the breast, and Gleason 6 prostate adenocarcinoma with very low or low risk prostate cancer intact; or definitively treated prostate cancer determined to be in remission.
  • Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Extracranial palliative radiation within 2 weeks of study enrollment.
  • Known autoimmune conditions requiring systemic immune suppressive therapy other than prednisone less than or equal to 10 mg.
  • Symptomatic brain or leptomeningeal metastases, including patients who continue to require glucocorticoids and/or anti-seizure therapy for brain or leptomeningeal metastases. Treated, asymptomatic metastases are permitted provided the patient has completed radiation at least 2 weeks prior to day 1 and has been off steroids for at least 1 week prior to day 1 of study drug. Stable (MRI or CT with contrast performed >4 weeks apart), untreated brain metastases are permitted if patient does not require steroids or anti-seizure therapy.
  • History of interstitial pneumonitis from any cause.
  • Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, or in the opinion of the investigator any physiological state likely to cause systemic or regional hypoxemia).
  • Intolerance to prior PD-1/L1 treatment including discontinuation for severe or recurrent severe toxicity (including myocarditis or other myocardiotoxicity, encephalitis, colitis, diarrhea, pancreatitis, hypo/hyperthyroidism, hypopituitarism, adrenal insufficiency, rash, autonomic neuropathy, myasthenia gravis, Guillain-Barre, myositis/polymyositis, hepatitis, Type 1 Diabetes, thrombocytopenia) or known anaphylaxis/allergy or severe hypersensitivity to CHO products or developed an immune checkpoint blockade related immune adverse event that was refractory to steroids and required additional systemic immunosuppressive medication. Prior topical steroids for rashes and oral steroids with control of prior immune-mediated adverse event are permitted.
  • Other Criteria will apply

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