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    DRUG:

    Onivyde (nanoliposomal irinotecan)

    i
    Other names: MM-398, MM 398, MM398, PEP 02, PEP02, nal-IRI, SHP673, SHP-673, BAX-2398, S095013, BAX 2398, BAX2398, PEP-02, S-095013, S 095013, SHP 673
    Company:
    Ipsen, PharmaEngine, Servier
    Drug class:
    Topoisomerase I inhibitor
    Related drugs:
    15h
    GIANT: Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread (clinicaltrials.gov)
    P2, N=176, Active, not recruiting, ECOG-ACRIN Cancer Research Group | Trial primary completion date: Jun 2026 --> Mar 2026
    Trial primary completion date
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    gemcitabine • albumin-bound paclitaxel • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • fluorouracil topical
    4d
    NCI-2019-07966: Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma (clinicaltrials.gov)
    P2, N=52, Recruiting, University of Wisconsin, Madison | Trial completion date: Dec 2027 --> May 2028 | Trial primary completion date: Dec 2026 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Herceptin (trastuzumab) • 5-fluorouracil • Onivyde (nanoliposomal irinotecan)
    17d
    3082-CL-0301: A study to confirm the safety of ASP3082, and if it delays tumor growth in people with pancreatic cancer, when given with either mFOLFIRINOX or NALIRIFOX chemotherapies (2025-523684-38-00)
    P2/3, N=35, Not yet recruiting, Astellas Pharma Global Development Inc.
    New P2/3 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • setidegrasib (ASP3082) • Onivyde (nanoliposomal irinotecan)
    19d
    A Study of NALIRIFOX in Combination With Radiation Therapy in People With Pancreatic Ductal Adenocarcinoma (PDAC) (clinicaltrials.gov)
    P2, N=60, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: May 2026 --> May 2027 | Trial primary completion date: May 2026 --> May 2027
    Trial completion date • Trial primary completion date
    |
    5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    24d
    Neoadjuvant Radiotherapy Combined With NALIRIFOX and Adebrelimab in pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Randomized, Phase II Clinical Trial (clinicaltrials.gov)
    P2, N=84, Not yet recruiting, Sun Yat-sen University
    New P2 trial • pMMR
    |
    5-fluorouracil • capecitabine • oxaliplatin • irinotecan • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • AiRuiLi (adebrelimab)
    1m
    NALIRIFOX+Adebrelimab+PULSAR for Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=55, Recruiting, West China Hospital
    New P1/2 trial
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • AiRuiLi (adebrelimab)
    1m
    RAD-NALIRIFOX: Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer (clinicaltrials.gov)
    P2, N=42, Active, not recruiting, Shandong Cancer Hospital and Institute | Not yet recruiting --> Active, not recruiting
    Enrollment closed
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    2ms
    ONITT: Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma (clinicaltrials.gov)
    P1/2, N=90, Recruiting, St. Jude Children's Research Hospital | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial primary completion date
    |
    EWSR1 (EWS RNA Binding Protein 1) • FLI1 (Fli-1 Proto-Oncogene ETS Transcription Factor)
    |
    temozolomide • Talzenna (talazoparib) • Onivyde (nanoliposomal irinotecan)
    2ms
    SGT-53 in Children With Recurrent or Progressive CNS Malignancies (clinicaltrials.gov)
    P1, N=0, Withdrawn, SynerGene Therapeutics, Inc. | Not yet recruiting --> Withdrawn
    Trial withdrawal
    |
    Avastin (bevacizumab) • temozolomide • irinotecan • Onivyde (nanoliposomal irinotecan) • SGT-53
    2ms
    Perioperative NALIRIFOX in patients with resectable pancreatic ductal adenocarcinoma: updated analysis of survival and circulating and genetic biomarkers from the phase II nITRO trial. (PubMed, ESMO Open)
    Long-term results from the nITRO trial confirm the activity of perioperative NALIRIFOX in resectable PDAC. Inflammatory, genomic, and pharmacogenomic biomarkers strongly influenced treatment response, surgical eligibility, survival, and toxicity. Biomarker integration could enable more precise patient stratification and guide personalized perioperative strategies in PDAC.
    P2 data • Journal
    |
    TNFA (Tumor Necrosis Factor-Alpha) • DPYD (Dihydropyrimidine Dehydrogenase)
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    2ms
    Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not Previously Treated for Metastatic Adenocarcinoma of the Pancreas (clinicaltrials.gov)
    P2, N=41, Completed, Institut de Recherches Internationales Servier | Active, not recruiting --> Completed | Trial completion date: Jan 2026 --> Sep 2025
    Trial completion • Trial completion date
    |
    5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • levoleucovorin calcium
    2ms
    Impact of UGT1A1*28 polymorphism in patients with metastatic pancreatic ductal adenocarcinoma treated with NALIRIFOX in the NAPOLI 3 trial. (PubMed, Future Oncol)
    To evaluate the effect of UGT1A1*28 homozygosity on the safety profile of NALIRIFOX (liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) in NAPOLI 3 (NCT04083235). This pre-specified exploratory analysis evaluated safety outcomes by UGT1A1*28 status in patients with mPDAC receiving NALIRIFOX or gemcitabine plus nab-paclitaxel in NAPOLI 3...These findings support the use of full NALIRIFOX dosing irrespective of UGT1A1*28 status. www.clinicaltrials.gov identifier is NCT04083235; EudraCT 2018-003585-14.
    Journal
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)