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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
    2ms
    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)
    3ms
    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)
    4ms
    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)
    7ms
    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)
    9ms
    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)
    11ms
    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)
    1year
    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)
    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 2024 --> Jul 2025 | Trial primary completion date: Jul 2023 --> Jul 2024
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Inlyta (axitinib) • ivuxolimab (PF-04518600)
    over1year
    InCITe: Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients With Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=150, Recruiting, Hope Rugo, MD | Trial completion date: Jul 2023 --> Jun 2024 | Trial primary completion date: Jul 2023 --> Jun 2024
    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)
    over1year
    OX40, Venetoclax, Avelumab, Glasdegib, Gemtuzumab Ozogamicin, and Azacitidine in Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=50, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | N=138 --> 50
    Trial completion • Enrollment change
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    Venclexta (venetoclax) • Bavencio (avelumab) • azacitidine • Mylotarg (gemtuzumab ozogamicin) • Daurismo (glasdegib) • ivuxolimab (PF-04518600)
    over1year
    A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) (clinicaltrials.gov)
    P1b/2, N=405, Terminated, Pfizer | Active, not recruiting --> Terminated; The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522)
    Trial termination • Combination therapy • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • EGFR mutation • ALK translocation
    |
    Bavencio (avelumab) • vidutolimod (CMP-001) • utomilumab (PF-05082566) • PD 360324 • 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 2023 --> Sep 2024 | Trial primary completion date: Sep 2022 --> Sep 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CD8 (cluster of differentiation 8)
    |
    Bavencio (avelumab) • utomilumab (PF-05082566) • ivuxolimab (PF-04518600)
    2years
    First-in-human study of an OX40 (ivuxolimab) and 4-1BB (utomilumab) agonistic antibody combination in patients with advanced solid tumors. (PubMed, J Immunother Cancer)
    Ivuxolimab+utomilumab was found to be well tolerated and demonstrated preliminary antitumor activity in selected groups of patients.
    P1 data • Clinical Trial,Phase I • Journal
    |
    PD-L1 (Programmed death ligand 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    utomilumab (PF-05082566) • ivuxolimab (PF-04518600)
    over2years
    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 | Recruiting --> Active, not recruiting | N=104 --> 62 | Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Jul 2022 --> Jul 2023
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1)
    |
    Inlyta (axitinib) • ivuxolimab (PF-04518600)
    over2years
    A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) (clinicaltrials.gov)
    P1b/2, N=398, Active, not recruiting, Pfizer | Trial completion date: Apr 2022 --> Feb 2023 | Trial primary completion date: Apr 2022 --> Feb 2023
    Trial completion date • Trial primary completion date • Combination therapy • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • EGFR mutation • ALK translocation
    |
    Bavencio (avelumab) • vidutolimod (CMP-001) • utomilumab (PF-05082566) • PD 360324 • ivuxolimab (PF-04518600)
    almost3years
    OX40, Venetoclax, Avelumab, Glasdegib, Gemtuzumab Ozogamicin, and Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=138, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    Venclexta (venetoclax) • Bavencio (avelumab) • azacitidine • Mylotarg (gemtuzumab ozogamicin) • Daurismo (glasdegib) • ivuxolimab (PF-04518600)
    almost3years
    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 | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed • Combination therapy
    |
    CD8 (cluster of differentiation 8)
    |
    Bavencio (avelumab) • utomilumab (PF-05082566) • ivuxolimab (PF-04518600)
    3years
    A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) (clinicaltrials.gov)
    P1b/2, N=398, Active, not recruiting, Pfizer | Trial completion date: Feb 2024 --> Apr 2022 | Trial primary completion date: Feb 2024 --> Apr 2022
    Clinical • Trial completion date • Trial primary completion date • Combination therapy • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • EGFR mutation • ALK translocation
    |
    Bavencio (avelumab) • vidutolimod (CMP-001) • utomilumab (PF-05082566) • PD 360324 • ivuxolimab (PF-04518600)
    over3years
    InCITe: Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients With Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=150, Recruiting, Hope Rugo, MD | Trial completion date: Jul 2021 --> Jul 2023 | Trial primary completion date: Jul 2021 --> Jul 2023
    Clinical • Trial completion date • Trial primary completion date
    |
    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)
    over3years
    A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) (clinicaltrials.gov)
    P1b/2, N=392, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=620 --> 392
    Clinical • Enrollment closed • Enrollment change • Combination therapy • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • EGFR mutation • ALK translocation
    |
    Bavencio (avelumab) • vidutolimod (CMP-001) • utomilumab (PF-05082566) • PD 360324 • ivuxolimab (PF-04518600)
    over3years
    Axitinib With or Without Anti-OX40 Antibody PF-04518600 in Treating Patients With Metastatic Kidney Cancer (clinicaltrials.gov)
    P2, N=104, Recruiting, University of Southern California | Trial completion date: Jul 2022 --> Jul 2023 | Trial primary completion date: Jul 2021 --> Jul 2022
    Clinical • Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1)
    |
    Inlyta (axitinib) • ivuxolimab (PF-04518600)
    over3years
    RITUXIMAB + IMMUNOTHERAPY IN FOLLICULAR LYMPHOMA (clinicaltrials.gov)
    P1b, N=24, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting | N=99 --> 24
    Enrollment closed • Enrollment change
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Rituxan (rituximab) • Bavencio (avelumab) • utomilumab (PF-05082566) • ivuxolimab (PF-04518600)
    4years
    [VIRTUAL] Interim Results of an Open-Label Phase IB/II Multi-Arm Study of OX40 Agonist Monoclonal Antibody (mAb), Anti-PDL1 Mab, Smoothened Inhibitor, Anti-CD33 Mab, Bcl-2 Inhibitor, and Azacitidine As Single-Agents and As Combinations for Relapsed/Refractory Acute Myeloid Leukemia (ASH 2020)
    Background: Several novel agents, including venetoclax (VEN), gemtuzumab ozogamicin (GO), and glasdegib have shown promise in newly diagnosed AML...Pts were assigned at the treating physician’s discretion to one of 5 concomitantly enrolling arms: A.) azacitidine (AZA) + VEN + GO, B.) AZA + VEN + avelumab (anti-PDL1 mAb), C.) AZA + avelumab + GO, D.) OX40 agonist mAb (PF-04518600), or E.) glasdegib + GO... All 3 novel triplet combination regimens were safe and demonstrated preliminary efficacy even in pts with prior VEN exposure. Outcomes of AZA + VEN + GO in pts who had not received prior VEN were particularly promising with a CR/CRi/MLFS rate of 80%, which compares favorably to response rates of 50-55% with HMA + VEN in similar R/R pts, although numbers are still small. Future accrual will focus on these 3 triplet combination regimens.
    Clinical • P1/2 data • PD(L)-1 Biomarker • IO biomarker
    |
    TP53 (Tumor protein P53) • NPM1 (Nucleophosmin 1)
    |
    NPM1 mutation
    |
    Venclexta (venetoclax) • Bavencio (avelumab) • azacitidine • Mylotarg (gemtuzumab ozogamicin) • Daurismo (glasdegib) • ivuxolimab (PF-04518600)
    over4years
    A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) (clinicaltrials.gov)
    P1b/2, N=620, Recruiting, Pfizer | Trial completion date: Dec 2022 --> Feb 2024 | Trial primary completion date: Dec 2022 --> Feb 2024
    Clinical • Trial completion date • Trial primary completion date • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • EGFR mutation • ALK translocation
    |
    Bavencio (avelumab) • vidutolimod (CMP-001) • utomilumab (PF-05082566) • PD 360324 • ivuxolimab (PF-04518600)
    over4years
    InCITe: Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients With Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=150, Recruiting, Hope Rugo, MD | Trial completion date: Jun 2023 --> Jul 2021 | Trial primary completion date: Jun 2020 --> Jul 2021
    Clinical • 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)
    over4years
    Axitinib With or Without Anti-OX40 Antibody PF-04518600 in Treating Patients With Metastatic Kidney Cancer (clinicaltrials.gov)
    P2, N=104, Recruiting, University of Southern California | Trial completion date: Jul 2021 --> Jul 2022 | Trial primary completion date: Jul 2020 --> Jul 2021
    Clinical • Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1)
    |
    Inlyta (axitinib) • ivuxolimab (PF-04518600)