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    DRUG:

    urelumab (BMS-663513)

    i
    Other names: BMS-663513, ONO-4481, BMS-66513
    Associations

    News

    Trials
    Company:
    BMS, Ono Pharmaceutical
    Drug class:
    CD137 agonist
    Related drugs:
    Associations

    News

    Trials
    20h
    Neoadjuvant Nivolumab With and Without Urelumab in Cisplatin-Ineligible or Chemotherapy-refusing Patients With Muscle-Invasive Urothelial Carcinoma of the Bladder (clinicaltrials.gov)
    P2, N=15, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Jul 2026 --> Jul 2027
    Trial completion date • Trial primary completion date • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • urelumab (BMS-663513)
    3ms
    Safety, feasibility and pharmacodynamic activity of intratumoral injections of the agonist anti-CD137 (4-1BB) mAb urelumab in combination with nivolumab. (PubMed, Clin Cancer Res)
    Intratumoral delivery of urelumab is feasible, safe, and induces favorable immunopharmacodynamic effects in serial biopsies and in peripheral blood. Our results support the development of tumor-targeted next-generation CD137 (4-1BB) agonists.
    PK/PD data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    Opdivo (nivolumab) • urelumab (BMS-663513)
    4ms
    Development of a nanoparticle-based immunotherapy targeting CD137 for nasopharyngeal carcinoma treatment. (PubMed, Theranostics)
    Urelumab and utomilumab, are two agonistic anti-CD137 antibodies that are most advanced in clinical trials but suffer from liver toxicity and low potency, respectively. In contrast to ure-MSNs, rhCD137-MSN treatment did not induce liver damage, thereby demonstrating a more favorable safety profile than ure-MSNs. This study identifies a formulation of rhCD137L on MSNs that combines high potency with excellent safety.
    Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    utomilumab (PF-05082566) • urelumab (BMS-663513)
    5ms
    Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov)
    P2, N=76, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Oct 2025 --> May 2026
    Trial primary completion date • IO biomarker
    |
    Opdivo (nivolumab) • cyclophosphamide • BMS-986253 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)
    9ms
    Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov)
    P2, N=76, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting --> Active, not recruiting
    Enrollment closed • IO biomarker
    |
    Opdivo (nivolumab) • cyclophosphamide • BMS-986253 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)
    9ms
    Neoadjuvant Nivolumab With and Without Urelumab in Cisplatin-Ineligible or Chemotherapy-refusing Patients With Muscle-Invasive Urothelial Carcinoma of the Bladder (clinicaltrials.gov)
    P2, N=15, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Jul 2025 --> Jul 2026
    Trial completion date • Trial primary completion date • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • urelumab (BMS-663513)
    11ms
    Rationale and feasibility of a rapid integral biomarker program that informs immune-oncology clinical trials: the ADVISE trial. (PubMed, J Immunother Cancer)
    Actualization of a patient-specific I-O combination treatment selection strategy is feasible, however, determination of de novo integral biomarker thresholds of novel I-O targets to facilitate effective treatment of PD-1-refractory cancer remains fraught. These data emphasize the difficulty of integral biomarker development for I-O in translating from immunotherapy treatment-naïve biospecimens to the selection of patients in the PD-1-refractory state.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3) • TNFA (Tumor Necrosis Factor-Alpha) • IDO1 (Indoleamine 2,3-dioxygenase 1) • CSF1R (Colony stimulating factor 1 receptor) • FOXP3 (Forkhead Box P3)
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • linrodostat (BMS-986205) • cabiralizumab (BMS-986227) • relatlimab (BMS-986016) • BMS-986156 • lirilumab (BMS-986015) • urelumab (BMS-663513)
    12ms
    Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov)
    P2, N=76, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Aug 2026 --> May 2026
    Trial completion date • IO biomarker
    |
    Opdivo (nivolumab) • cyclophosphamide • BMS-986253 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)
    1year
    Development of a tumor-region-selective activation monoclonal antibody targeting the 4-1BB receptor for enhanced therapeutic efficacy and safety. (PubMed, Int J Biol Macromol)
    Additionally, Pro-Urelumab achieved 77 % tumor growth inhibition (TGI), compared to 45 % with Urelumab, and significantly increased T cell activation within the tumor. This study underscores the potential of tumor-selective 4-1BB activation for enhancing both the efficacy and safety of immuno-oncology therapies.
    Journal
    |
    CD8 (cluster of differentiation 8) • MMP2 (Matrix metallopeptidase 2) • MMP9 (Matrix metallopeptidase 9)
    |
    urelumab (BMS-663513)
    over1year
    Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov)
    P2, N=76, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2025 --> Aug 2026 | Trial primary completion date: Dec 2024 --> Aug 2025
    Trial completion date • Trial primary completion date • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • TNFRSF9 (TNF Receptor Superfamily Member 9) • GZMB (Granzyme B) • IL17A (Interleukin 17A)
    |
    CD8 expression
    |
    Opdivo (nivolumab) • cyclophosphamide • BMS-986253 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)
    over1year
    Neoadjuvant Nivolumab With and Without Urelumab in Cisplatin-Ineligible or Chemotherapy-refusing Patients With Muscle-Invasive Urothelial Carcinoma of the Bladder (clinicaltrials.gov)
    P2, N=15, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • urelumab (BMS-663513)
    2years
    Development of a c-MET x CD137 bispecific antibody for targeted immune agonism in cancer immunotherapy. (PubMed, Cancer Treat Res Commun)
    Overall, the c-MET x CD137 BsAb exhibits a promising developability profile as a tumor-targeted immune agonist by minimizing off-target effects while effectively delivering immune agonism. It has the potential to overcome resistance to anti-PD-(L)1 therapies.
    Journal
    |
    MET (MET proto-oncogene, receptor tyrosine kinase) • TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    MET expression
    |
    Keytruda (pembrolizumab) • utomilumab (PF-05082566) • urelumab (BMS-663513)