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Libtayo (cemiplimab) is a human antibody that targets PD-1 (PDCD1) and prevents interaction with PD-L1 (CD274) and PD-L2 (PDCD1LG2), potentially resulting in increased anti-tumor immune response and decreased tumor growth (PMID: 28265006). Libtayo (cemiplimab) is FDA approved for use in patients with cutaneous squamous cell carcinoma, who are not not eligible for curative surgery or radiation (FDA.gov).
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Cemiplimab||Libtayo||REGN2810|SAR439684||Immune Checkpoint Inhibitor 94 PD-L1/PD-1 antibody 63||Libtayo (cemiplimab) is a human antibody that targets PD-1 (PDCD1) and prevents interaction with PD-L1 (CD274) and PD-L2 (PDCD1LG2), potentially resulting in increased anti-tumor immune response and decreased tumor growth (PMID: 28265006). Libtayo (cemiplimab) is FDA approved for use in patients with cutaneous squamous cell carcinoma, who are not not eligible for curative surgery or radiation (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||squamous cell carcinoma||not applicable||Cemiplimab||FDA approved||Actionable||In a Phase I and a Phase II trial that supported FDA approval, Libtayo (cemiplimab) treatment resulted in an objective response rate of 46.7% (35/75), a complete response rate of 5.3% (4/75), and a partial response rate of 41.3% (31/75) in patients with metastatic cutaneous squamous cell carcinoma (PMID: 29863979; NCT02383212, NCT02760498).||detail... 29863979|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status|
|NCT03132636||Phase II||Cemiplimab||PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy||Active, not recruiting|
|NCT03580694||Phase I||Cemiplimab + REGN4659 Cemiplimab||Study of REGN4659 in Combination With Cemiplimab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)||Terminated|
|NCT03969004||Phase III||Cemiplimab||Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma||Recruiting|
|NCT04315701||Phase II||Cemiplimab||A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer||Not yet recruiting|
|NCT04428671||Phase I||Cemiplimab||Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer||Recruiting|
|NCT03690869||Phase Ib/II||Cemiplimab||REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma||Recruiting|
|NCT03565783||Phase II||Cemiplimab||Study of REGN2810 Prior to Surgery in Patients With Advanced-Stage, Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck||Recruiting|
|NCT02760498||Phase II||Cemiplimab||Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma||Recruiting|
|NCT03669718||Phase II||Cemiplimab + ISA101b Cemiplimab||A Randomized Phase 2 Study of Cemiplimab +/- ISA101b in HPV16-Positive OPC||Recruiting|
|NCT03257267||Phase III||Irinotecan Gemcitabine Vinorelbine Pemetrexed Disodium Cemiplimab Topotecan||Study of REGN2810 in Adults With Cervical Cancer||Active, not recruiting|
|NCT04339062||Phase I||Cemiplimab Cemiplimab + Everolimus + Prednisone Cemiplimab + Prednisone + Sirolimus||Cemiplimab in AlloSCT/SOT Recipients With CSCC (CONTRAC)||Recruiting|
|NCT03889912||Phase I||Cemiplimab||Pre-Operative Cemiplimab Administered Intralesionally for Patients With Recurrent Cutaneous Squamous Cell Carcinoma||Recruiting|
|NCT03916627||Phase II||Cemiplimab||Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC||Recruiting|
|NCT03409614||Phase III||Cemiplimab + Ipilimumab Cemiplimab||REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer||Recruiting|
|NCT03430063||Phase II||Cemiplimab + Ipilimumab Cemiplimab||A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer||Active, not recruiting|
|NCT03477864||Phase I||Ipilimumab Cemiplimab + Ipilimumab Cemiplimab||Stereotactic Body Radiation Therapy With REGN2810 and/or Ipilimumab Before Surgery in Treating Participants With Progressive Advanced or Oligometastatic Prostate Cancer||Withdrawn|
|NCT02651662||Phase I||Cemiplimab Cemiplimab + Odronextamab||Study of REGN2810 and REGN1979 in Patients With Lymphoma||Active, not recruiting|
|NCT04154943||Phase II||Cemiplimab||Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma||Recruiting|
|NCT02383212||Phase I||Carboplatin + Cemiplimab + Docetaxel Carboplatin + Cemiplimab + Pemetrexed Disodium Cemiplimab + Cyclophosphamide + Sargramostim Cemiplimab + Cyclophosphamide Cemiplimab Carboplatin + Cemiplimab + Paclitaxel Cemiplimab + Docetaxel||Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies||Completed|