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    DRUG:

    Imjudo (tremelimumab-actl)

    i
    Other names: CP-675206, CP-675,206, CP-675, PF-06753388, CP 675, CP675, PF 06753388, PF06753388, CP675206, CP 675206
    Company:
    AstraZeneca, Pfizer
    Drug class:
    CTLA4 inhibitor
    Related drugs:
    2d
    Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV Non-small Cell Lung Cancer, IMMUNO-BIOMAP Trial (clinicaltrials.gov)
    P2, N=535, Not yet recruiting, City of Hope Medical Center
    New P2 trial • IO biomarker
    |
    Avastin (bevacizumab) • Imfinzi (durvalumab) • Imjudo (tremelimumab-actl) • Krazati (adagrasib) • Aybintio (bevacizumab biosimilar) • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn)
    4d
    NCI-2018-01581: Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=70, Recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2025 --> Dec 2026 | Trial primary completion date: Nov 2025 --> Dec 2026
    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) • CD4 (CD4 Molecule)
    |
    HER-2 negative • PD-L1 negative
    |
    carboplatin • Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • Imjudo (tremelimumab-actl) • Trodelvy (sacituzumab govitecan-hziy) • Hiltonol (poly-ICLC)
    11d
    Durvalumab With/Without Tremelimumab After Palliative Hypofractionated Radiotherapy for Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=21, Recruiting, Mary Feng, MD | Trial completion date: Feb 2027 --> Jul 2029 | Trial primary completion date: Feb 2027 --> Jul 2028
    Trial completion date • Trial primary completion date
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    PD-L1 (Programmed death ligand 1)
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    11d
    T Cell Receptor and Immune Gene Expression Pharmacodynamics for Durvalumab alone and with Tremelimumab or Bevacizumab in Unresectable Hepatocellular Carcinoma. (PubMed, Clin Cancer Res)
    These findings suggest that STRIDE and D+B have distinct, and potentially complementary, mechanisms of action in uHCC.
    PK/PD data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule)
    |
    Avastin (bevacizumab) • Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    14d
    Immunotherapy Combined With Y-90 SIRT Therapy in Advanced Stage Intrahepatic Biliary Tract Cancer (BTC) (clinicaltrials.gov)
    P2, N=50, Active, not recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Aug 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    20d
    Prior Radiotherapy Improves Progression-free Survival in Patients With Advanced Hepatocellular Carcinoma Treated With Tremelimumab-Durvalumab. (PubMed, Anticancer Res)
    Prior radiotherapy improves PFS in patients treated with tremelimumab-durvalumab for advanced HCC. The abscopal effect and up-regulation of immune mechanisms may contribute to improved outcomes.
    Retrospective data • Journal
    |
    CD8 (cluster of differentiation 8)
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    21d
    SIERRA: Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC) (clinicaltrials.gov)
    P3, N=111, Active, not recruiting, AstraZeneca | Trial primary completion date: Sep 2025 --> Dec 2025
    Trial primary completion date
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    24d
    Integrated therapies for targeting the microenvironment of hepatocellular carcinoma. (PubMed, Drug Discov Today)
    Immune checkpoint inhibitors (tremelimumab and durvalumab) in combination with small- molecule agents (lenvatinib and cabozantinib) enhance T-cell activation and improve progression-free survival in HCC...HCC ME has distinct immune subtypes exhibiting different responses to treatments, which complicates biomarker selection and treatment timing. Personalized therapy based on ME is the future path in HCC management.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    GPC3 (Glypican 3)
    |
    Imfinzi (durvalumab) • Lenvima (lenvatinib) • Cabometyx (cabozantinib tablet) • Imjudo (tremelimumab-actl)
    28d
    ADRIATIC: Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy (clinicaltrials.gov)
    P3, N=730, Active, not recruiting, AstraZeneca | Trial completion date: Mar 2026 --> Oct 2026
    Trial completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    28d
    A signal-seeking phase 2 study of tremelimumab in advanced cancers with high tumour mutational burden. (PubMed, NPJ Precis Oncol)
    Seven tremelimumab-related serious adverse events (grade 2-3) occurred in 5 patients. While the primary PFS6 endpoint was not met, there were two durable objective responses in rare cancers and a favourable change in disease trajectory for an additional five patients based on TTP ratio 1.3.
    P2 data • Journal • Tumor mutational burden
    |
    TMB (Tumor Mutational Burden)
    |
    TMB-H
    |
    FoundationOne® CDx • TruSight Oncology 500 Assay • TruSight Tumor 170 Assay
    |
    Imjudo (tremelimumab-actl)
    1m
    Advances in PD-1 and CTLA-4 dual-target immunotherapy for ovarian cancer. (PubMed, Front Immunol)
    Clinical evidence indicates that programmed death-1/cytotoxic T-lymphocyte-associated protein 4 (PD-1/CTLA-4) dual immune checkpoint blockade strategies (e.g., durvalumab plus tremelimumab, nivolumab plus ipilimumab) exhibit differential therapeutic effects: durable treatment responses have been observed in recurrent/platinum-resistant advanced OC, while neoadjuvant applications have significantly improved complete resection rates. In conclusion, despite existing challenges, dual-target immunotherapy has demonstrated clinically meaningful benefits, offering new therapeutic options for advanced and recurrent OC patients and heralding a new era of combination immunotherapy in OC treatment. Future large-scale clinical studies are warranted to further validate efficacy and establish individualized precision treatment strategies.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    1m
    A Pilot Trial of Preoperative Irradiation With the STRIDE (Single Dose of Tremelimumab With Ongoing Durvalumab) Regimen (PRISM) for Resectable/Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=0, Withdrawn, Weill Medical College of Cornell University | N=10 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)