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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| NCT04428671 | Phase I | Cemiplimab | Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer | Recruiting | USA | 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 |
| NCT04315701 | Phase II | Cemiplimab | A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer | Recruiting | USA | 0 |
| 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 |
| 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 |
| 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 |
| 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 |
| NCT04632433 | Phase II | Cemiplimab | Neoadjuvant Plus Adjuvant Treatment With Cemiplimab in Cutaneaous Squamous Cell Carcinoma | Active, not recruiting | ITA | 0 |
| NCT04339062 | Phase I | Cemiplimab Cemiplimab + Everolimus + Prednisone Cemiplimab + Prednisone + Sirolimus | Cemiplimab in AlloSCT/SOT Recipients With CSCC (CONTRAC) | Active, not recruiting | USA | 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 |
| NCT02760498 | Phase II | Cemiplimab | Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma | Completed | USA | ITA | FRA | ESP | DEU | AUS | 2 |
| 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 |
| NCT05878288 | Phase II | Cemiplimab | Deep sequencIng in Cutaneous Squamous CEll caRciNomas (DISCERN) | Recruiting | AUS | 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 | |
| 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 |
| 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 |
| NCT05967884 | Phase II | Cemiplimab Cemiplimab + Dupilumab | PD-1 +/- IL-4 Inhibition in ER+ Breast Cancer | Not yet recruiting | CAN | 0 |
| NCT05929664 | Phase II | Cemiplimab | Cemiplimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery | Recruiting | USA | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NCT03916627 | Phase II | Cemiplimab | Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC | Recruiting | USA | 0 |
| 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 |
| 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 |
| 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 |
| NCT03889912 | Phase I | Cemiplimab | Pre-Operative Cemiplimab Administered Intralesionally for Patients With Recurrent Cutaneous Squamous Cell Carcinoma | Recruiting | USA | 0 |
| NCT05574101 | Phase II | Cemiplimab | A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer | Recruiting | USA | 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 |
| NCT02651662 | Phase I | Cemiplimab Cemiplimab + Odronextamab | Study of REGN2810 and REGN1979 in Patients With Lymphoma | Recruiting | USA | ESP | DEU | 0 |
| NCT04873375 | Phase II | Cemiplimab | Cemiplimab for Secondary Angiosarcomas | Recruiting | NLD | 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 |
| 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 |
| 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 |
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