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    DRUG:

    Libtayo (cemiplimab-rwlc)

    i
    Other names: REGN2810, SAR439684, REGN 2810, SAR 39684, REGN-2810, SAR-439684
    Company:
    GENESIS Pharma, Medison, Regeneron
    Drug class:
    PD1 inhibitor
    Related drugs:
    1d
    Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=13, Completed, H. Lee Moffitt Cancer Center and Research Institute | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 negative
    |
    capecitabine • Libtayo (cemiplimab-rwlc)
    1d
    PROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically Resectable Melanoma (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial
    |
    Yervoy (ipilimumab) • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    2d
    Trial assessing fianlimab plus cemiplimab plus chemotherapy or cemiplimab plus chemotherapy in patients with pleural mesothelioma (2024-519208-29-00)
    P1/2, N=126, Recruiting, Intergroupe Francophone De Cancerologie Thoracique | Not yet recruiting --> Recruiting
    Enrollment open
    |
    pemetrexed • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    4d
    IMMUNOLIFE2: Oral Pooled Fecal Microbiotherapy (MaaT033) Concomitant to Cemiplimab Versus Best Investigator's Choice in Patients With Resistance to Treatment Due to Antibiotics Uptake With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=162, Recruiting, Gustave Roussy, Cancer Campus, Grand Paris | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Avastin (bevacizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • docetaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • MaaT033 • Navelbine oral (vinorelbine tartrate oral)
    5d
    Reduced-dose Carboplatin-doublet-chemotherapy + Cemiplimab vs Cemiplimab Monotherapy in Treatment Naive Older and Frail Patients With Metastatic NSCLC With PD-L1 <50% (clinicaltrials.gov)
    P2, N=156, Recruiting, Swiss Cancer Institute | Not yet recruiting --> Recruiting | Trial completion date: Mar 2030 --> Sep 2030 | Trial primary completion date: Mar 2028 --> Sep 2028
    Enrollment open • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    carboplatin • gemcitabine • paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc)
    11d
    NEOPECS: Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=27, Not yet recruiting, Melanoma and Skin Cancer Trials Limited | Trial completion date: Dec 2028 --> Dec 2030 | Trial primary completion date: Jan 2026 --> Jul 2026
    Trial completion date • Trial primary completion date
    |
    Erbitux (cetuximab) • Libtayo (cemiplimab-rwlc)
    11d
    C-POST: Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=415, Active, not recruiting, Regeneron Pharmaceuticals | Trial primary completion date: Nov 2026 --> Jan 2028
    Trial primary completion date
    |
    Libtayo (cemiplimab-rwlc)
    13d
    CLeAR: Cemiplimab +/- Fianlimab Post Y90 Radioembolization in Patients With Hepatocellular Carcinoma (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Virginia Commonwealth University | Initiation date: Feb 2026 --> Jul 2026
    Trial initiation date
    |
    CD4 (CD4 Molecule)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    14d
    First-Line Cemiplimab for Locally Advanced NSCLC: Updated Subgroup Analyses From the EMPOWER-Lung 1 and EMPOWER-Lung 3 Trials. (PubMed, JTO Clin Res Rep)
    Favorable patient-reported outcomes were observed with cemiplimab monotherapy than chemotherapy; no significant patient-reported outcomes favoring chemotherapy were observed in either study. This subgroup analysis supports the clinical benefit of 1L cemiplimab as monotherapy or combined with chemotherapy in patients with unresectable locally advanced NSCLC (not candidates for definitive chemoradiotherapy).
    Journal • PD(L)-1 Biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Libtayo (cemiplimab-rwlc)
    14d
    Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery (clinicaltrials.gov)
    P2, N=70, Recruiting, Thomas Jefferson University | Trial completion date: Jul 2027 --> Jul 2031 | Trial primary completion date: Jul 2027 --> Jul 2031
    Trial completion date • Trial primary completion date
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    15d
    A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=120, Recruiting, Regeneron Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    20d
    ARCH: A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients With Surgically Removed Non-small Cell Lung Cancer Who Have Not Received Prior Chemotherapy (clinicaltrials.gov)
    P3, N=390, Recruiting, ETOP IBCSG Partners Foundation
    Trial initiation date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Libtayo (cemiplimab-rwlc)