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    DRUG:

    utomilumab (PF-05082566)

    i
    Other names: PF-05082566 , PF-2566, PF-5082566, PF05082566, PF2566, PF5082566, PF 05082566, PF 2566, PF 5082566
    Company:
    Novartis, Pfizer
    Drug class:
    CD137 agonist
    Related drugs:
    3d
    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)
    1m
    NCI-2018-01118: Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients With Advanced Malignancies (clinicaltrials.gov)
    P1/2, N=173, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Sep 2025 --> Apr 2026
    Trial completion date
    |
    Bavencio (avelumab) • utomilumab (PF-05082566) • ivuxolimab (PF-04518600)
    5ms
    The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer (clinicaltrials.gov)
    P2, N=100, Active, not recruiting, Adrienne G. Waks | Trial completion date: May 2025 --> May 2026
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 positive • HER-2 amplification
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Bavencio (avelumab) • vinorelbine tartrate • utomilumab (PF-05082566)
    7ms
    InCITe: Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=150, Recruiting, Laura Huppert, MD, BA | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Jun 2026
    Trial completion date • Trial primary completion date • Tumor mutational burden
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Bavencio (avelumab) • Mektovi (binimetinib) • pegylated liposomal doxorubicin • Trodelvy (sacituzumab govitecan-hziy) • utomilumab (PF-05082566) • ivuxolimab (PF-04518600)
    8ms
    Avelumab, Utomilumab, Rituximab, Ibrutinib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma (clinicaltrials.gov)
    P1, N=16, Completed, City of Hope Medical Center | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Jun 2024 | Trial primary completion date: Dec 2024 --> Jun 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1)
    |
    CD20 positive
    |
    carboplatin • Imbruvica (ibrutinib) • Rituxan (rituximab) • Bavencio (avelumab) • cyclophosphamide • ifosfamide • etoposide IV • Truxima (rituximab-abbs) • utomilumab (PF-05082566)
    10ms
    Rituximab + Immunotherapy in Follicular Lymphoma (clinicaltrials.gov)
    P1, N=24, Terminated, Dana-Farber Cancer Institute | Phase classification: P1b --> P1 | Active, not recruiting --> Terminated; Stopped was stopped prematurely due to drug manufacturer withdrawing supply/funding. Patients already enrolled on study were allowed to continue treatment.
    Phase classification • Trial termination
    |
    Rituxan (rituximab) • Bavencio (avelumab) • utomilumab (PF-05082566) • ivuxolimab (PF-04518600)
    1year
    NCI-2018-01118: Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients with Advanced Malignancies (clinicaltrials.gov)
    P1/2, N=173, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CD8 (cluster of differentiation 8)
    |
    Bavencio (avelumab) • utomilumab (PF-05082566) • ivuxolimab (PF-04518600)
    over1year
    A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) (clinicaltrials.gov)
    P1/2, N=409, Terminated, Pfizer | Phase classification: P1b/2 --> P1/2
    Phase classification • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Bavencio (avelumab) • vidutolimod (CMP-001) • utomilumab (PF-05082566) • PD 360324 • ivuxolimab (PF-04518600)
    over1year
    ZUMA-11: Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Adults With Refractory Large B-cell Lymphoma (clinicaltrials.gov)
    P1, N=15, Terminated, Kite, A Gilead Company | Phase classification: P1/2 --> P1
    Phase classification • Combination therapy
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    cyclophosphamide • Yescarta (axicabtagene ciloleucel) • fludarabine IV • utomilumab (PF-05082566)
    over1year
    Utomilumab, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1, N=42, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2023 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR • RAS mutation
    |
    Erbitux (cetuximab) • irinotecan • utomilumab (PF-05082566)
    over1year
    Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing (clinicaltrials.gov)
    P3, N=61, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=262 --> 61 | Trial completion date: May 2025 --> Sep 2026 | Trial primary completion date: May 2025 --> Sep 2026
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    Bavencio (avelumab) • Talzenna (talazoparib) • pemetrexed • Inlyta (axitinib) • vidutolimod (CMP-001) • utomilumab (PF-05082566) • ivuxolimab (PF-04518600)
    over1year
    Avelumab, Utomilumab, Rituximab, Ibrutinib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma (clinicaltrials.gov)
    P1, N=16, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1)
    |
    CD20 positive
    |
    carboplatin • Imbruvica (ibrutinib) • Rituxan (rituximab) • Bavencio (avelumab) • cyclophosphamide • ifosfamide • etoposide IV • utomilumab (PF-05082566)