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    DRUG:

    Imjudo (tremelimumab-actl)

    i
    Other names: PF06753388, CP675206, CP 675206, CP-675206, CP-675,206, CP-675, PF-06753388, CP 675, CP675, PF 06753388
    Company:
    AstraZeneca, Pfizer
    Drug class:
    CTLA4 inhibitor
    Related drugs:
    1m
    Pretreatment Tumor-infiltrating CD8+ T Cell Numbers Are Associated With the Response to Tremelimumab Plus Durvalumab in Hepatocellular Carcinoma. (PubMed, Anticancer Res)
    Pretreatment intratumoral CD8+ TIL density was associated with an improved response and a longer PFS in STRIDE-treated HCC. Baseline tumor immune contexture may serve as a practical predictive biomarker for STRIDE. These findings are exploratory and hypothesis-generating, and require validation in larger prospective studies.
    Retrospective data • Journal • PD(L)-1 Biomarker • IO biomarker
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    CD8 (cluster of differentiation 8)
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    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    2ms
    TREMENDOUS: Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With uHCC (clinicaltrials.gov)
    P3, N=214, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting | Trial completion date: Mar 2025 --> Sep 2026 | Trial primary completion date: Mar 2025 --> Sep 2026
    Enrollment closed • Trial completion date • Trial primary completion date
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    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    2ms
    IMMUWIN: Durvalumab and Tremelimumab in Combination With Y-90 SIRT for Intermediate Stage HCC (clinicaltrials.gov)
    P2, N=55, Active, not recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    2ms
    A PHASE 2 STUDY OF STRIDE (durvalumab + tremelimumab) With Lenvatinib Versus STRIDE Alone in Patients With Unresectable Hepatocellular Carcinoma (SLIDE-HCC) - HE.2 (2025-521608-23-00)
    P1/2, N=56, Not yet recruiting, IRCCS Istituto Nazionale Tumori Fondazione Pascale
    New P1/2 trial
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    Imfinzi (durvalumab) • Lenvima (lenvatinib) • Imjudo (tremelimumab-actl)
    2ms
    Autopsy-Proven Immune-Mediated Hepatitis With Rapid Liver Atrophy Despite Minimal Aminotransferase Elevation After Durvalumab Plus Tremelimumab Therapy for Hepatocellular Carcinoma: A Case Report. (PubMed, Clin Case Rep)
    The tumor burden was small without metastasis. This case highlights that ICI hepatitis can progress with minimal aminotransferase elevation in advanced cirrhosis, warranting multidimensional monitoring beyond aspartate aminotransferase/alanine aminotransferase, including bilirubin, coagulation parameters, clinical decompensation, and quantitative imaging.
    Journal
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    CD8 (cluster of differentiation 8)
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    2ms
    Real-World Comparison of First-Line Atezolizumab plus Bevacizumab and Durvalumab plus Tremelimumab for Unresectable Hepatocellular Carcinoma. (PubMed, Liver Cancer)
    This dissociation between PFS and OS may reflect differences in disease biology, treatment sequencing, and post-progression management rather than intrinsic superiority of either regimen. These findings highlight the importance of individualized treatment selection and careful consideration of tumor characteristics and hepatic reserve when choosing first-line immunotherapy for uHCC.
    Journal • Real-world evidence • PD(L)-1 Biomarker • IO biomarker
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    AFP (Alpha-fetoprotein)
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    AFP elevation
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    Avastin (bevacizumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    2ms
    STUDY 22: A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=433, Active, not recruiting, MedImmune LLC | Trial completion date: Apr 2026 --> Dec 2026
    Trial completion date
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    Avastin (bevacizumab) • Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    2ms
    SERPENTINE: Single cEll pRofiling PErsistaNce To ImmuNothErapy (clinicaltrials.gov)
    P2, N=60, Recruiting, Vall d'Hebron Institute of Oncology | Trial completion date: Dec 2025 --> Jul 2032 | Trial primary completion date: Sep 2025 --> Jul 2032
    Trial completion date • Trial primary completion date
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    RAS wild-type • EGFR positive
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    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    2ms
    Phase I/II, open-label, multicenter study of durvalumab in combination with tremelimumab in pediatric patients with advanced solid tumors. (PubMed, Front Oncol)
    D (30 mg/kg) + T (1 mg/kg) had limited antitumor activity in this pediatric population; however, the safety profile was manageable and consistent with the known safety profile in adult patients, with no new safety concerns identified. ClinicalTrials.gov, identifier NCT03837899; EudraCT, identifier 2018-003118-42.
    Clinical • P1/2 data • Journal
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    CD4 (CD4 Molecule)
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    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    3ms
    NILE: Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer (clinicaltrials.gov)
    P3, N=1246, Active, not recruiting, AstraZeneca | Trial completion date: Apr 2026 --> Jun 2027
    Trial completion date
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    cisplatin • carboplatin • Imfinzi (durvalumab) • gemcitabine • Imjudo (tremelimumab-actl)
    3ms
    Neoadjuvant Durvalumab ± Tremelimumab in Combination With Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin in Muscle-Invasive Bladder Carcinoma: Results of the Phase I/II NEMIO Study. (PubMed, J Clin Oncol)
    Neoadjuvant ddMVAC plus durvalumab demonstrated encouraging pCR rates, favorable early survival outcomes, and manageable safety profile. Adding tremelimumab provides similar pCR but worse toxicity. These results support further study of ddMVAC plus durvalumab as a neoadjuvant chemoimmunotherapy strategy for localized MIBC, to be evaluated in comparative trials within an evolving perioperative treatment landscape.
    P1/2 data • Journal
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 underexpression • PD-L1 negative
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    cisplatin • Imfinzi (durvalumab) • doxorubicin hydrochloride • Imjudo (tremelimumab-actl) • methotrexate • vinblastine • Neulasta (pegfilgrastim)
    3ms
    MONTEROSA - Italian Multicenter Observational Study to Evaluate Time to Clinical Hepatic Decompensation, Quality of Life, Effectiveness, and Safety of Tremelimumab Plus Durvalumab in Patients With Advanced or Unresectable Hepatocellular Carcinoma Who Have Received no Prior Systemic Treatment. (clinicaltrials.gov)
    P=N/A, N=200, Recruiting, AstraZeneca
    New trial • HEOR • Real-world evidence
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    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)