^
    18d
    Personalization of Neoadjuvant Immunotherapy in High-Risk Resectable Melanoma and Utility of ctDNA as a Biomarker of Immunotherapy Response. (PubMed, Ann Surg Oncol)
    A personalized surgical approach to neoadjuvant ICI was feasible, with comparable recurrence rates between the patients who underwent INE and those who underwent TLND. For the patients without MPR, subsequent adjuvant therapy improved recurrence-free survival (p = 0.046). The ctDNA results correlated with the clinical outcomes, suggesting that ctDNA may complement pathologic response in guiding management.
    Journal • PD(L)-1 Biomarker • IO biomarker • Circulating tumor DNA
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    Signatera™
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • relatlimab (BMS-986016)
    26d
    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)
    1m
    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)
    1m
    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)
    1m
    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)
    1m
    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)
    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
    |
    LAG3 (Lymphocyte Activating 3)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    2ms
    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)
    2ms
    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)
    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
    |
    PD-L1 (Programmed death ligand 1)
    |
    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
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)