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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:
    2d
    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)
    7d
    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
    |
    AFP (Alpha-fetoprotein)
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    AFP elevation
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    Avastin (bevacizumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    7d
    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
    |
    Avastin (bevacizumab) • Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    9d
    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
    |
    RAS wild-type • EGFR positive
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    9d
    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
    |
    CD4 (CD4 Molecule)
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    13d
    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
    |
    cisplatin • carboplatin • Imfinzi (durvalumab) • gemcitabine • Imjudo (tremelimumab-actl)
    15d
    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)
    |
    PD-L1 underexpression • PD-L1 negative
    |
    cisplatin • Imfinzi (durvalumab) • doxorubicin hydrochloride • Imjudo (tremelimumab-actl) • methotrexate • vinblastine • Neulasta (pegfilgrastim)
    15d
    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
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    28d
    ESR-16-12192: Durvalumab (MEDI4736 ) plus tremelimumab in resectable, locally advanced squamous cell carcinoma of the oral cavity: a window of opportunity study (2024-511511-25-00)
    P1/2, N=21, Completed, UZ Leuven | Active, not recruiting --> Completed
    Trial completion
    |
    cisplatin • Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    29d
    TREMENDOUS-2: Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=114, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Imfinzi (durvalumab) • Lenvima (lenvatinib) • Imjudo (tremelimumab-actl)
    29d
    REFINE-IO: An Observational Study to Learn More About How Well a Treatment Works When Given After Treatment With Atezolizumab and Bevacizumab or Another Similar Combination of Drugs in Adults With Liver Cancer That Cannot be Treated With Surgery (clinicaltrials.gov)
    P=N/A, N=300, Active, not recruiting, Bayer | Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2026 --> Dec 2025
    Enrollment closed • Trial primary completion date • Checkpoint inhibition
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    1m
    An unusual presentation of Hepatocellular Carcinoma: Isolated bile duct involvement without detectable hepatic mass. (PubMed, Z Gastroenterol)
    Given the advanced stage of disease, systemic immunotherapy with tremelimumab and durvalumab was initiated. This case underscores the critical role of a multimodal diagnostic approach in atypical presentations of HCC to enable accurate diagnosis and appropriate therapeutic decision-making.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    TP53 (Tumor protein P53) • GPC3 (Glypican 3)
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)