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    CANCER:

    Urothelial Cancer

    Related cancers:
    22h
    KEYNOTE A99: Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) (clinicaltrials.gov)
    P1/2, N=296, Active, not recruiting, Inhibrx Biosciences, Inc | Recruiting --> Active, not recruiting
    Enrollment closed
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    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden)
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    EGFR mutation • TMB-H • MSI-H/dMMR • ALK rearrangement
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    PD-L1 IHC 22C3 pharmDx
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    Keytruda (pembrolizumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • ordastobart (INBRX-106)
    2d
    Overcoming resistance in advanced urothelial carcinoma: mechanisms of escape from antibody-drug conjugates and FGFR3 inhibition. (PubMed, Front Oncol)
    Enfortumab vedotin, a Nectin-4 targeting ADC, is now the first line therapy of choice in combination with pembrolizumab. Erdafitinib, a pan FGFR1-4 inhibitor, is approved for patients with susceptible FGFR3 alterations...We propose strategies for overcoming resistance including combination strategies, tumor microenvironment modification, and drug structure modification to maximize efficacy. The progress to date in mUC has been remarkable, but there is still significant work to do in this deadly disease and this review highlights the gap between current available therapeutics and cure that so desperately needs to be closed.
    Review • Journal
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    FGFR3 (Fibroblast growth factor receptor 3) • NECTIN4 (Nectin Cell Adhesion Molecule 4)
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    Keytruda (pembrolizumab) • Balversa (erdafitinib) • Padcev (enfortumab vedotin-ejfv)
    2d
    A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors (clinicaltrials.gov)
    P1/2, N=428, Not yet recruiting, Astellas Pharma Global Development, Inc.
    New P1/2 trial
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    Keytruda (pembrolizumab) • carboplatin • Padcev (enfortumab vedotin-ejfv)
    2d
    Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Urothelium (clinicaltrials.gov)
    P2, N=31, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial completion date • Trial primary completion date
    3d
    The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas (clinicaltrials.gov)
    P2, N=27, Not yet recruiting, Mayo Clinic
    New P2 trial
    4d
    A Clinical Study of the Efficacy and Safety of Disitamab Vedotin in Combination With Radiotherapy for the Adjuvant Treatment of HER2 Overexpressing UTUC Patients With High Risk Factors for Recurrence After Radical Surgery (clinicaltrials.gov)
    P2, N=60, Recruiting, Peking University First Hospital | Not yet recruiting --> Recruiting
    Enrollment open
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    Aidixi (disitamab vedotin)
    4d
    IMCODE-004: A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-risk Muscle-invasive Urothelial Carcinoma (MIUC) (clinicaltrials.gov)
    P2, N=362, Recruiting, Hoffmann-La Roche | Trial primary completion date: Nov 2028 --> Mar 2029
    Trial primary completion date • IO biomarker
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    PD-L1 (Programmed death ligand 1)
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    Opdivo (nivolumab) • autogene cevumeran (RG6180)
    4d
    Cryoablation With Pembrolizumab Or Avelumab In Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=30, Recruiting, Massachusetts General Hospital | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date
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    Keytruda (pembrolizumab) • Bavencio (avelumab)
    4d
    Comprehensive molecular profiling of urologic tumors presented in a molecular tumor board: insights from a real-world precision oncology cohort. (PubMed, Front Oncol)
    Comprehensive molecular profiling in a MTB setting reveals distinct and therapeutically relevant mutational patterns across urologic cancers. These data support the integration of MTBs into clinical workflows and highlight the potential of co-mutational signatures to guide personalized treatment strategies.
    Journal • Real-world evidence • Tumor mutational burden • BRCA Biomarker • PARP Biomarker
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    TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PBRM1 (Polybromo 1) • KMT2D (Lysine Methyltransferase 2D) • LRP1B (LDL Receptor Related Protein 1B) • KMT2C (Lysine Methyltransferase 2C) • APC (APC Regulator Of WNT Signaling Pathway) • SETD2 (SET Domain Containing 2, Histone Lysine Methyltransferase) • PARP1 (Poly(ADP-Ribose) Polymerase 1) • SPTA1 (Spectrin Alpha) • SFTPA1 (Surfactant Protein A1)
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    TP53 mutation
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    TruSight Oncology 500 Assay
    4d
    Small cell bladder carcinoma with a high tumor mutational burden responding to sequential cisplatin-etoposide and pembrolizumab: a case report. (PubMed, Int Cancer Conf J)
    This case highlights the role of genomic profiling test for clinical decision-making as tumor mutational burden predicts the efficacy of immune checkpoint inhibitor therapy in SCCB. This case also underscores the urgent need for novel treatment approaches for SCCB.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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    TMB (Tumor Mutational Burden)
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    TMB-H
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    Keytruda (pembrolizumab) • cisplatin • etoposide IV
    4d
    Neoadjuvant chemoradiotherapy plus programmed cell death protein-1 blockade versus chemoradiotherapy alone for muscle-invasive bladder cancer: a real-world comparative study. (PubMed, Front Immunol)
    Chemotherapy comprised gemcitabine 1,000 mg/m² (days 1 and 8) and cisplatin 70 mg/m² (days 2-3) every 21 days for ≥3 cycles...Toripalimab and tislelizumab achieved comparable PDRs (83.33% vs. 92.86%, p=0.613) and PCRRs (66.67% vs. 78.57%, p=0.694)...NACRT combined with PD-1 blockade significantly improved PCRR without increasing toxicity in patients with MIBC. These findings support conducting a prospective single-arm phase II multicenter trial to confirm potential long-term survival benefits.
    Clinical • Retrospective data • Journal • Real-world evidence
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    PD-1 (Programmed cell death 1)
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    cisplatin • gemcitabine • Loqtorzi (toripalimab-tpzi) • Tevimbra (tislelizumab-jsgr)