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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
    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)
    4ms
    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)
    5ms
    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)
    |
    Inlyta (axitinib) • ivuxolimab (PF-04518600)
    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)
    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
    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)
    |
    Inlyta (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)
    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)
    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 • Inlyta (axitinib) • vidutolimod (CMP-001) • utomilumab (PF-05082566) • ivuxolimab (PF-04518600)
    almost2years
    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, Hope Rugo, MD | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Tumor mutational burden • Metastases
    |
    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)
    2years
    A multi-cohort phase 1b trial of rituximab in combination with immunotherapy doublets in relapsed/refractory follicular lymphoma. (PubMed, Ann Hematol)
    We therefore conducted a phase 1b trial testing time-limited therapy with different immunotherapy doublets targeting 4-1BB (utomilumab), OX-40 (ivuxolimab), and PD-L1 (avelumab) in combination with rituximab among patients with relapsed/refractory grade 1-3A FL. Abundance of Akkermansia in stool samples was also associated with response. Our results support a possible role for 4-1BB agonist therapy in FL and suggest that features of the tumor microenvironment and stool microbiome may be associated with clinical outcomes (NCT03636503).
    P1 data • Journal • Combination therapy
    |
    TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    Rituxan (rituximab) • Bavencio (avelumab) • utomilumab (PF-05082566) • ivuxolimab (PF-04518600)