^
    4d
    Human Serum Albumin-Lipid Nanocapsules of Duvelisib for Hematological Cancers: Characterization, In-Vitro Cell-Culture, Toxicity and Pharmacokinetic Studies. (PubMed, AAPS PharmSciTech)
    The DUV-NCs were found to be safe in toxicity studies with no major alterations in biomarkers compared to the control. In conclusion, DUV-NCs is a promising strategy to deliver DUV in hematological malignancies with improved efficacy and safety.
    PK/PD data • Preclinical • Journal
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    PIK3CG (Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Gamma)
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    Copiktra (duvelisib)
    14d
    Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov)
    P2, N=15, Active, not recruiting, City of Hope Medical Center | Trial completion date: Nov 2025 --> Oct 2026
    Trial completion date
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    BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1) • FCER2 (Fc Fragment Of IgE Receptor II)
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    Chr t(11;14)
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    Copiktra (duvelisib) • ETP-47187
    20d
    Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, Washington University School of Medicine | Trial completion date: Dec 2025 --> Apr 2026 | Trial primary completion date: Dec 2025 --> Apr 2026
    Trial completion date • Trial primary completion date
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    Copiktra (duvelisib)
    28d
    Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome (clinicaltrials.gov)
    P1, N=38, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2027 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
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    Opdivo (nivolumab) • Copiktra (duvelisib) • ABP 206 (nivolumab biosimilar) • ETP-47187
    30d
    Duvelisib Maintenance for the Treatment of Peripheral T-Cell Lymphomas (clinicaltrials.gov)
    P2, N=25, Not yet recruiting, City of Hope Medical Center
    New P2 trial
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    Copiktra (duvelisib) • ETP-47187
    1m
    Duvelisib in Combination With Nivolumab in Patients With Advanced Unresectable Melanoma (clinicaltrials.gov)
    P1/2, N=13, Terminated, John Kirkwood | Trial completion date: Dec 2028 --> Feb 2025 | Active, not recruiting --> Terminated; Secura Bio, Inc. discontinued support of the trial.
    Trial completion date • Trial termination
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    BRAF (B-raf proto-oncogene)
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    BRAF mutation
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    Opdivo (nivolumab) • axitinib • Copiktra (duvelisib)
    1m
    Dual PI3Kδ/γ inhibition enhances radiotherapy-induced antitumor immunity via macrophage-dependent cGAS-STING-type I interferon signaling. (PubMed, Biochem Biophys Res Commun)
    In the syngeneic CT26 model, dual PI3Kδ/γ inhibition (BR101801 or duvelisib), unlike selective PI3Kδ inhibition (idelalisib), synergized with RT (7.5 Gy) to suppress tumor growth and induce durable immune memory. Furthermore, blockade of the IFN-I receptor abolished CD8+ T cell infiltration and M2-like macrophage suppression, abrogating antitumor efficacy and confirming the requirement for IFN-I signaling. These findings identify macrophage-driven activation of the cGAS-STING-IFN-I axis as a key mechanism by which dual PI3Kδ/γ inhibition potentiates RT, providing a strong scientific rationale for its development as an immunomodulatory radiosensitizer.
    Journal
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    CD8 (cluster of differentiation 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • PIK3CG (Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Gamma) • PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta) • STING (stimulator of interferon response cGAMP interactor 1) • CGAS (Cyclic GMP-AMP Synthase)
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    Zydelig (idelalisib) • Copiktra (duvelisib) • bosmolisib (BR101801)
    3ms
    Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC (clinicaltrials.gov)
    P2, N=26, Completed, Glenn J. Hanna | Active, not recruiting --> Completed
    Trial completion
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    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
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    docetaxel • Copiktra (duvelisib)
    3ms
    Expression Modulation of Immune Inhibitory Molecules by Small Molecule Inhibitor Drugs in Leukemic Cells of Chronic Lymphocytic Leukemia. (PubMed, Iran J Pharm Res)
    This study examined the effects of signaling pathway inhibitors ibrutinib, idelalisib, duvelisib, and venetoclax on the expression of immune checkpoint ligands: Programmed death ligand 1 (PD-L1), galectin-9 (Gal-9), cluster of differentiation (CD)200, CD155, and herpes virus entry mediator (HVEM) in CLL leukemic cells. Altogether, the treatment of leukemic cells with different SMIs in this study indicated increased or decreased variations in the expression level of immune checkpoint inhibitory ligands in CLL. Therefore, these mechanisms should be considered for further treatment approaches, especially for combinational strategies.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1) • CD200 (CD200 Molecule) • PVR (PVR Cell Adhesion Molecule) • LGALS9 (Galectin 9)
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    PD-L1 expression
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    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Zydelig (idelalisib) • Copiktra (duvelisib)
    4ms
    Combination of HDAC inhibitor and PI3K inhibitor suppresses autophagy and induces apoptosis via cytoplasmic IκBα stabilization in p53-mutant diffuse large B-cell lymphoma. (PubMed, Cell Death Discov)
    In this study, we systematically validated the synergistic therapeutic potential of HDAC inhibitor chidamide and PI3K inhibitor duvelisib in p53+ DLBCL through cellular models, in vivo experiments, and clinical samples. This acetylation promoted histone H1.5-IκBα interactions, further stabilizing IκBα and attenuating p65 nuclear trafficking. Our findings identify a novel and potent therapeutic strategy for p53+ DLBCL, warranting clinical translation.
    Journal • P53mut
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    TP53 (Tumor protein P53) • PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta) • HDAC2 (Histone deacetylase 2) • NFKBIA (NFKB Inhibitor Alpha 2)
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    TP53 mutation • TP53 wild-type
    |
    Copiktra (duvelisib) • Epidaza (chidamide)
    4ms
    A051902: Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma (clinicaltrials.gov)
    P2, N=170, Suspended, Alliance for Clinical Trials in Oncology | Recruiting --> Suspended
    Trial suspension
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    PD-1 (Programmed cell death 1) • TNFRSF8 (TNF Receptor Superfamily Member 8) • BCL6 (B-cell CLL/lymphoma 6) • CXCL13 (Chemokine (C-X-C motif) ligand 13) • ICOS (Inducible T Cell Costimulator) • MME (Membrane Metalloendopeptidase)
    |
    TNFRSF8 expression
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    doxorubicin hydrochloride • cyclophosphamide • etoposide IV • Copiktra (duvelisib) • vincristine • prednisone • Onureg (azacitidine oral)
    5ms
    A Phase 1b/2 Study of IPI-145 Plus FCR in Previously Untreated, Younger Patients With CLL (clinicaltrials.gov)
    P1/2, N=32, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Jul 2025 --> Jul 2026
    Trial completion date
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    Rituxan (rituximab) • cyclophosphamide • Copiktra (duvelisib) • fludarabine IV