^
    1d
    RELATIVITY-069: A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adults With Hodgkin and Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=5, Terminated, Bristol-Myers Squibb | Completed --> Terminated
    Trial termination
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    Opdivo (nivolumab) • relatlimab (BMS-986016)
    3d
    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)
    5d
    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 | Trial completion date: Oct 2026 --> Oct 2027 | Trial primary completion date: Jul 2026 --> Oct 2027
    Trial completion date • Trial primary completion date
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    LAG3 (Lymphocyte Activating 3)
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    Opdivo (nivolumab) • Yervoy (ipilimumab) • relatlimab (BMS-986016)
    10d
    RELATIVITY-104: A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=468, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed
    Trial completion • IO biomarker
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    PD-L1 (Programmed death ligand 1)
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    Opdivo (nivolumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • relatlimab (BMS-986016)
    12d
    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)
    15d
    Study of Relatlimab and Nivolumab (Opdualag) in Replication Repair Deficient HGG and DIPG (clinicaltrials.gov)
    P2, N=12, Not yet recruiting, Nationwide Children's Hospital
    New P2 trial
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    TMB (Tumor Mutational Burden)
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    TMB-H
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    Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    16d
    Tobemstomig, a novel bispecific antibody, preferentially blocks PD-1 and LAG-3 on CD8 TILs to expand stem-like T-cells for sustained tumor control. (PubMed, Cancer Res Commun)
    To address this limitation, we developed tobemstomig, a novel bispecific antibody to preferentially and simultaneously block PD-1 and LAG-3 in cis on tumor-specific CD8 TILs, while sparing Tregs. It provided superior tumor growth inhibition in mouse models by replenishing stem-like cells and cytotoxic effector CD8 TILs, resulting in durable responses compared to monospecific antibodies targeting PD-1 and LAG-3 separately, which eroded the stem-like T cell pool over time.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
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    tobemstomig (RG6139)
    17d
    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
    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™
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    Opdivo (nivolumab) • Yervoy (ipilimumab) • relatlimab (BMS-986016)
    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)