^
    6d
    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)
    7d
    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)
    9d
    Ion-Channel-Mediated Drug Repurposing Opportunities Validated by Single-Cell Perturbation in Colorectal Cancer. (PubMed, Int J Mol Sci)
    Immune checkpoint receptors (LAG3, CD27) connect via PPI intermediates to Ca2+ and K+ channels, targetable by relatlimab (FDA-approved) and varlilumab (Phase 2). This work maps previously unknown links between CRC driver genes and ion channel regulation, with the ataluren-RPS21-KCNQ2 axis ready for pharmacological testing.
    Journal • IO biomarker
    |
    LAG3 (Lymphocyte Activating 3) • CD27 (CD27 Molecule)
    |
    relatlimab (BMS-986016) • varlilumab (CDX 1127) • Translarna (ataluren)
    13d
    KEYMAKER-U04 Substudy: A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04) (clinicaltrials.gov)
    P1/2, N=390, Active, not recruiting, Merck Sharp & Dohme LLC | Completed --> Active, not recruiting | N=49 --> 390
    Enrollment closed • Enrollment change
    |
    PD-L1 (Programmed death ligand 1)
    |
    Padcev (enfortumab vedotin-ejfv) • favezelimab/pembrolizumab (MK-4280A) • vibostolimab/pembrolizumab (MK-7684A)
    19d
    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)
    20d
    CA224-056: Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer (clinicaltrials.gov)
    P2, N=80, Active, not recruiting, Dan Zandberg | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    LAG3 (Lymphocyte Activating 3)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • relatlimab (BMS-986016)
    21d
    ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab (clinicaltrials.gov)
    P4, N=90, Recruiting, NYU Langone Health | Not yet recruiting --> Recruiting
    Enrollment open • Circulating tumor DNA
    |
    BRAF (B-raf proto-oncogene) • IFNA1 (Interferon Alpha 1)
    |
    Signatera™
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • relatlimab (BMS-986016)
    27d
    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
    |
    PD-L1 (Programmed death ligand 1)
    |
    cisplatin • carboplatin • paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    28d
    Fianlimab&Cemiplimab as TotalNeoadj The (TNT) ForMelanoma (clinicaltrials.gov)
    P2, N=35, Not yet recruiting, University of California, Irvine
    New P2 trial
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    1m
    AARON: Relatlimab With Nivolumab and 5-Azacytidine for the Treatment of AML (clinicaltrials.gov)
    P2, N=30, Completed, Ludwig-Maximilians - University of Munich | Active, not recruiting --> Completed
    Trial completion
    |
    Opdivo (nivolumab) • azacitidine • relatlimab (BMS-986016)
    1m
    A first-in-human phase 1 clinical trial evaluating clinical activity and proof-of-mechanism of tobemstomig, a PD1-LAG3 bispecific antibody, in patients with CPI-experienced melanoma. (PubMed, Clin Cancer Res)
    Tobemstomig had a tolerable and manageable safety profile across various advanced solid tumor indications. The encouraging antitumor activity associated with pharmacodynamic activity, and proof-of-mechanism in CPI-experienced melanoma patients, indicates the therapeutic potential of tobemstomig and supports further investigation in earlier disease treatment settings.
    P1 data • Journal • First-in-human
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • LAG3 (Lymphocyte Activating 3)
    |
    tobemstomig (RG6139)