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    DRUG:

    ivuxolimab (PF-04518600)

    i
    Other names: PF-04518600, PF-8600, PF 04518600, PF 4518600, PF04518600, 11D4, B110
    Associations

    News

    Trials
    Company:
    Pfizer
    Drug class:
    OX40 agonist
    Related drugs:
    Associations

    News

    Trials
    4d
    Tumor microenvironment changes after treatment with avelumab and immune- stimulating agent combinations in patients with advanced solid tumors. (PubMed, Res Sq)
    Methods We performed whole exome sequencing (WES), bulk RNAseq, multiplex immunofluorescence (mIF) and chromogenic immunohistochemistry (IHC) on tumor tissue and flow cytometry of the peripheral blood to study longitudinal changes following the combination of avelumab with utomilumab (a 4-1BB agonist) (arm A), PF-04518600 (an OX40 agonist) (arm B), utomilumab and PF-04518600 (arm C) and utomilumab and radiotherapy (arm D) in phase I/II study (NCT03217747). Conclusions Our findings, though limited, highlight genomic differences between histologic subsets and outcome as well as the need for combination strategies that drive the recruitment and/or priming of anti-tumor T cells and address low immune permissive tumor states in patients with advanced solid tumors. Clinical trial registration: This clinical trial was registered on clinicaltrials.gov NCT03217747.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • CCNE1 (Cyclin E1) • IFNG (Interferon, gamma) • TTN (Titin)
    |
    TP53 mutation • KRAS mutation • KRAS G12C • KRAS G12D • TMB-L • KRAS G12
    |
    Bavencio (avelumab) • utomilumab (PF-05082566) • ivuxolimab (PF-04518600)
    2ms
    Axitinib With or Without Anti-OX40 Antibody PF-04518600 in Treating Patients With Metastatic Kidney Cancer (clinicaltrials.gov)
    P2, N=62, Active, not recruiting, University of Southern California | Trial primary completion date: Dec 2025 --> Jun 2026
    Trial primary completion date • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1)
    |
    axitinib • ivuxolimab (PF-04518600)
    4ms
    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)
    7ms
    Advancing In Vivo Detection of T-Cell Function: Development and Preclinical Evaluation of 89Zr-Ivuxolimab, a Human OX40 PET Tracer. (PubMed, J Nucl Med)
    Deferoxamine conjugation and 89Zr radiolabeling were optimized for ivuxolimab. 89Zr-ivuxolimab is a promising radiotracer for clinical translation as an imaging agent for activated T cells. Further investigation of its ability to monitor and predict response to different cancer immunotherapy modalities is warranted.
    Preclinical • Journal • IO biomarker
    |
    TNFRSF4 (TNF Receptor Superfamily Member 4)
    |
    ivuxolimab (PF-04518600)
    8ms
    Axitinib With or Without Anti-OX40 Antibody PF-04518600 in Treating Patients With Metastatic Kidney Cancer (clinicaltrials.gov)
    P2, N=62, Active, not recruiting, University of Southern California | Trial completion date: Jul 2026 --> Dec 2026 | Trial primary completion date: Jul 2025 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    axitinib • ivuxolimab (PF-04518600)
    9ms
    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)
    1year
    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)
    over1year
    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
    Axitinib With or Without Anti-OX40 Antibody PF-04518600 in Treating Patients With Metastatic Kidney Cancer (clinicaltrials.gov)
    P2, N=62, Active, not recruiting, University of Southern California | Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    axitinib • 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)
    almost2years
    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 • axitinib • vidutolimod (CMP-001) • utomilumab (PF-05082566) • ivuxolimab (PF-04518600)
    almost2years
    Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing (clinicaltrials.gov)
    P3, N=262, Recruiting, Pfizer | Trial completion date: Dec 2025 --> May 2025 | Trial primary completion date: Dec 2025 --> May 2025
    Trial completion date • Trial primary completion date
    |
    Bavencio (avelumab) • Talzenna (talazoparib) • pemetrexed • axitinib • vidutolimod (CMP-001) • utomilumab (PF-05082566) • ivuxolimab (PF-04518600)