Therapy Detail

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Therapy Name Cemiplimab
Synonyms
Therapy Description

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, in patients with locally advanced or metastatic basal cell carcinoma who have received or are not eligible for a hedgehog pathway inhibitor, as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression (TPS>=50%) and no EGFR, ALK, or ROS1 aberrations, and in combination with platinum-based chemotherapy as first-line treatment for patients with NSCLC without EGFR, ALK, or ROS1 alterations (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Cemiplimab Libtayo REGN2810|SAR439684 Immune Checkpoint Inhibitor 147 PD-L1/PD-1 antibody 117 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, in patients with locally advanced or metastatic basal cell carcinoma who have received or are not eligible for a hedgehog pathway inhibitor, as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression (TPS>=50%) and no EGFR, ALK, or ROS1 aberrations, and in combination with platinum-based chemotherapy as first-line treatment for patients with NSCLC without EGFR, ALK, or ROS1 alterations (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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 Completed USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 2
NCT03409614 Phase III Cemiplimab + Ipilimumab Cemiplimab Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer Active, not recruiting USA | ITA | FRA | AUT 14
NCT05574101 Phase II Cemiplimab A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer Recruiting USA 0
NCT05840770 Phase II Cemiplimab Cemiplimab for the Treatment of Untreated Brain Metastases From PD-L1 >= 50% Non-Small Cell Lung Cancer Not yet recruiting USA 0
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 USA 0
NCT03889912 Phase I Cemiplimab Pre-Operative Cemiplimab Administered Intralesionally for Patients With Recurrent Cutaneous Squamous Cell Carcinoma Recruiting USA 0
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 0
NCT04526899 Phase II Cemiplimab BNT111 BNT111 + Cemiplimab Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD1-refractory/Relapsed, Unresectable Stage III or IV Melanoma Active, not recruiting USA | ITA | GBR | ESP | DEU | AUS 1
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 USA | NZL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 6
NCT03669718 Phase II Cemiplimab + ISA101b Cemiplimab A Randomized Phase 2 Study of Cemiplimab +/- ISA101b in HPV16-Positive OPC Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | BEL 5
NCT05538988 Phase Ib/II Cemiplimab BIOmarker-guided Study to Evaluate the Efficacy and Safety of cemipLimab for advancEd Cutaneous T-cell Lymphoma (BIOSELECT) Not yet recruiting CAN 0
NCT03916627 Phase II Cemiplimab Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC Recruiting USA 0
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 Terminated USA 0
NCT04315701 Phase II Cemiplimab A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer Recruiting USA 0
NCT04873375 Phase II Cemiplimab Cemiplimab for Secondary Angiosarcomas Recruiting NLD 0
NCT05557591 Phase II Cemiplimab BNT116 + Cemiplimab Safety and Efficacy of Intravenous Cemiplimab Plus BNT116 Versus Cemiplimab Alone in Advanced Non-Small Cell Lung Cancer in Adult Participants With PD-L1 >= 50% Recruiting USA | ESP | DEU 2
NCT03257267 Phase III Irinotecan Gemcitabine Vinorelbine Pemetrexed Disodium Cemiplimab Topotecan Study of REGN2810 in Adults With Cervical Cancer Completed USA | ITA | GBR | ESP | CAN | BEL | AUS 7
NCT05401786 Phase II Cemiplimab Ipilimumab Anti-PD-1 Re-challenge After Immune Priming by Ipilimumab and Immune Boosting by Radiotherapy in Advanced NSCLC (RAD-IO) Recruiting NLD 0
NCT05929664 Phase II Cemiplimab Cemiplimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery Recruiting USA 0
NCT05785767 Phase II Cemiplimab Cemiplimab + Fianlimab A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Recruiting USA | AUS 2
NCT05967884 Phase II Cemiplimab Cemiplimab + Dupilumab PD-1 +/- IL-4 Inhibition in ER+ Breast Cancer Not yet recruiting CAN 0
NCT05878288 Phase II Cemiplimab Deep sequencIng in Cutaneous Squamous CEll caRciNomas (DISCERN) Recruiting AUS 0
NCT03430063 Phase II Cemiplimab + Ipilimumab Cemiplimab A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer Terminated USA | GBR | FRA | ESP | DEU | BEL 3
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 USA | ESP | AUS 0
NCT04387084 Phase I Durvalumab Pembrolizumab Avelumab Cemiplimab Atezolizumab Nivolumab Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy Recruiting USA 0
NCT02760498 Phase II Cemiplimab Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma Completed USA | ITA | FRA | ESP | DEU | AUS 2
NCT02651662 Phase I Cemiplimab Cemiplimab + Odronextamab Study of REGN2810 and REGN1979 in Patients With Lymphoma Recruiting USA | ESP | DEU 0
NCT04154943 Phase II Cemiplimab Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma Active, not recruiting USA | DEU | AUS 0
NCT05961709 Phase II Cemiplimab The Phoenix Trial: Phase II Trial of Cemiplimab for the Non-operative Management of Localized dMMR Colon Cancer Not yet recruiting USA 0
NCT04988074 Phase II Cemiplimab Carboplatin + Cemiplimab + Paclitaxel Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca (MINIMA) Recruiting USA 0
NCT04975152 Phase I Cemiplimab Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell Carcinoma Recruiting USA 0
NCT04632433 Phase II Cemiplimab Neoadjuvant Plus Adjuvant Treatment With Cemiplimab in Cutaneaous Squamous Cell Carcinoma Active, not recruiting ITA 0
NCT06205836 Phase II Cemiplimab Cemiplimab + Fianlimab Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer Not yet recruiting USA 0
NCT04428671 Phase I Cemiplimab Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer Recruiting USA 0
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 USA 0
NCT01042379 Phase II Trilaciclib Trastuzumab Duocarmazine Cyclophosphamide + Doxorubicin Cemiplimab Amcenestrant Abemaciclib + Amcenestrant Carboplatin + Dostarlimab-gxly + HM30181A + Paclitaxel + Trastuzumab Amcenestrant + Letrozole Carboplatin + Dostarlimab-gxly + HM30181A + Paclitaxel Pertuzumab + Trastuzumab + Trilaciclib Paclitaxel + Trastuzumab Pertuzumab + Trastuzumab Cemiplimab + Fianlimab I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY) Recruiting USA 0
NCT04339062 Phase I Cemiplimab Cemiplimab + Everolimus + Prednisone Cemiplimab + Prednisone + Sirolimus Cemiplimab in AlloSCT/SOT Recipients With CSCC (CONTRAC) Active, not recruiting USA 0
NCT05352672 Phase III Cemiplimab Cemiplimab + Fianlimab Pembrolizumab Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma Recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 13


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