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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:
    4d
    Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer (clinicaltrials.gov)
    P2, N=44, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: May 2028 --> May 2030 | Trial primary completion date: May 2028 --> May 2030
    Trial completion date • Trial primary completion date • MSI-H
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    4d
    R4018-ONC-1721: Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers (clinicaltrials.gov)
    P1/2, N=890, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Jan 2027 --> May 2027 | Trial primary completion date: Feb 2026 --> May 2027
    Trial completion date • Trial primary completion date
    |
    MUC16 (Mucin 16, Cell Surface Associated)
    |
    Libtayo (cemiplimab-rwlc) • Actemra IV (tocilizumab) • ubamatamab (REGN4018) • Kevzara (sarilumab)
    4d
    A Safety and Efficacy Study of Combined Fianlimab + Cemiplimab in Children and Young Adults With Recurrent or Progressive High-Grade Glioma or Posterior Fossa-A Ependymoma (clinicaltrials.gov)
    P1/2, N=120, Not yet recruiting, Regeneron Pharmaceuticals
    New P1/2 trial
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    5d
    NRG-HN014: Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer (clinicaltrials.gov)
    P3, N=420, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension
    |
    TMB (Tumor Mutational Burden)
    |
    TMB-H
    |
    Libtayo (cemiplimab-rwlc)
    6d
    The Phoenix Trial: Phase II Trial of Cemiplimab for the Non-operative Management of Localized dMMR Colon Cancer (clinicaltrials.gov)
    P2, N=50, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2026 --> Apr 2027
    Enrollment closed • Trial primary completion date • Tumor mutational burden • dMMR
    |
    MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
    |
    MSI-H/dMMR
    |
    Libtayo (cemiplimab-rwlc)
    10d
    A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1) (clinicaltrials.gov)
    P2, N=51, Active, not recruiting, Regeneron Pharmaceuticals | N=32 --> 51
    Enrollment change
    |
    PD-L1 (Programmed death ligand 1)
    |
    Libtayo (cemiplimab-rwlc) • BNT116
    11d
    Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer (clinicaltrials.gov)
    P2, N=180, Recruiting, National Cancer Institute (NCI) | Initiation date: Oct 2026 --> Apr 2026
    Trial initiation date
    |
    cisplatin • carboplatin • paclitaxel • Libtayo (cemiplimab-rwlc)
    13d
    ICING: Study of Isatuximab and Cemiplimab in Relapsed or Refractory Natural Killer/T-cell Lymphoid Malignancy (clinicaltrials.gov)
    P2, N=37, Completed, Won Seog Kim | Recruiting --> Completed
    Trial completion
    |
    PD-L1 (Programmed death ligand 1)
    |
    Libtayo (cemiplimab-rwlc) • Sarclisa (isatuximab-irfc)
    14d
    CEMIRESIST: Mechanisms of Resistance to anti-PD-1 Therapy in cutaneous Squamous Cell Carcinomas: Impact of Tumor Cell Plasticity on Promoting Myeloid Suppressor Cell Infiltration. A phase II single arm, unicenter study of cemiplimab in patients with locally advanced cSCCs. (2025-524255-32-00)
    P1/2, N=15, Not yet recruiting, Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL
    New P1/2 trial
    |
    Libtayo (cemiplimab-rwlc)
    16d
    Fianlimab, a human lymphocyte activation gene-3 monoclonal antibody, in combination with cemiplimab: Tumor-specific expansion cohorts in advanced malignancies. (PubMed, Cancer)
    Fianlimab plus cemiplimab demonstrated modest clinical efficacy with an acceptable safety profile in patients with advanced malignancies across several tumor types mostly in treatment-naive patients. Further investigation is warranted.
    Journal • First-in-human
    |
    LAG3 (Lymphocyte Activating 3)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    21d
    UC-IMM-2511/2512: METAREM / META-1 - METAREM :Immunotherapy Master Trial for Advanced Cancers / META-1: Immunotherapy without chemotherapy for advanced lung cancer patients with high PD-L1 Levels. (2025-522655-26-00)
    P1/2, N=55, Not yet recruiting, Unicancer
    New P1/2 trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK mutation
    |
    Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc)
    23d
    NeoMatryx: Neoadjuvant Merkel Cell Carcinoma Therapy (Tx) With the PD-1 Inhibitor Cemiplimab (clinicaltrials.gov)
    P2, N=135, Not yet recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Initiation date: Feb 2026 --> Jun 2026
    Trial initiation date
    |
    Libtayo (cemiplimab-rwlc)