^
    1d
    EMPIRE (NSABP FC-13): a biomarker-driven phase II platform trial evaluating cemiplimab-based immunotherapy in microsatellite-stable colorectal cancer with ctDNA-defined minimal residual disease. (PubMed, Future Oncol)
    Eligible patients have postoperative ctDNA positivity in the absence of radiographic recurrence and are allocated to one of three treatment arms: cemiplimab monotherapy; cemiplimab plus fianlimab (a lymphocyte activation gene-3 inhibitor); or cemiplimab plus REGN7075 (an EGFR×CD28 costimulatory bispecific antibody). Arms 2 and 3 use single-stage phase II designs, whereas Arm 1 follows a Simon two-stage design with early futility stopping. The study integrates comprehensive correlative analyses to characterize mechanisms of response and resistance.Clinical trial registration: The http://www.clinicaltrials.gov identifier is NCT07058012.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Minimal residual disease • Circulating tumor DNA
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    EGFR (Epidermal growth factor receptor) • LAG3 (Lymphocyte Activating 3)
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    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    10d
    A Study of Cemiplimab and Fianlimab in People With Nasopharyngeal Carcinoma (clinicaltrials.gov)
    P1, N=60, Not yet recruiting, Memorial Sloan Kettering Cancer Center
    New P1 trial
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    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    16d
    Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery (clinicaltrials.gov)
    P2, N=70, Suspended, Thomas Jefferson University | Recruiting --> Suspended
    Trial suspension
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    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    1m
    A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE) (clinicaltrials.gov)
    P2, N=79, Recruiting, NSABP Foundation Inc | Trial primary completion date: Jun 2028 --> Apr 2029 | Not yet recruiting --> Recruiting
    Enrollment open • Trial primary completion date • Minimal residual disease
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    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    2ms
    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
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    MSI (Microsatellite instability)
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    MSI-H/dMMR
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    2ms
    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
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    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    2ms
    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
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    LAG3 (Lymphocyte Activating 3)
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    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    2ms
    A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery (clinicaltrials.gov)
    P2, N=195, Recruiting, Regeneron Pharmaceuticals | Active, not recruiting --> Recruiting
    Enrollment open
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    PD-L1 (Programmed death ligand 1)
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    cisplatin • carboplatin • paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    2ms
    Fianlimab&Cemiplimab as TotalNeoadj The (TNT) ForMelanoma (clinicaltrials.gov)
    P2, N=35, Not yet recruiting, University of California, Irvine
    New P2 trial
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    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    3ms
    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
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    Yervoy (ipilimumab) • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    3ms
    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
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    pemetrexed • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    3ms
    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
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    CD4 (CD4 Molecule)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)