^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    Onivyde (nanoliposomal irinotecan)

    i
    Company:
    Ipsen, PharmaEngine, Servier, Yakult Honsha
    Drug class:
    Topoisomerase I inhibitor
    Related drugs:
    3d
    FUNGEMAX: First Line Metastatic Pancreatic Cancer : 5FU/LV+Nal-IRI, Gemcitabine+Nab-paclitaxel or a Sequential Regimen of 2 Months 5FU/LV+Nal-IRI (clinicaltrials.gov)
    P2, N=288, Active, not recruiting, Federation Francophone de Cancerologie Digestive | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Jul 2025
    Trial completion date • Trial primary completion date
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • Onivyde (nanoliposomal irinotecan)
    16d
    1-BETTER: XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=76, Active, not recruiting, XBiotech, Inc. | Completed --> Active, not recruiting | Trial completion date: Jun 2024 --> Jun 2025
    Enrollment closed • Trial completion date
    |
    5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • Natrunix (vilamakitug)
    17d
    NAPOLI-3: A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment (clinicaltrials.gov)
    P3, N=770, Completed, Ipsen | Active, not recruiting --> Completed
    Trial completion
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    20d
    Comparison of inflammatory markers before and after nanoliposomal irinotecan and fluorouracil with folic acid in patients with pancreatic cancer: results from the NAPOLEON-2 study (NN-2302). (PubMed, Ther Adv Med Oncol)
    Inflammatory markers can be used as biomarkers both before and after NFF treatment, and CAR may be useful. We hope these findings will contribute to the selection of appropriate treatment options.
    Journal
    |
    CRP (C-reactive protein)
    |
    5-fluorouracil • Onivyde (nanoliposomal irinotecan)
    20d
    NALIRIFOX in Japanese treatment-naïve patients with metastatic pancreatic adenocarcinoma: an open-label, phase II trial design. (PubMed, Future Oncol)
    Forty-one participants will receive the treatment NALIRIFOX (liposomal irinotecan, 5-fluorouracil, levoleucovorin and oxaliplatin) until progression or unacceptable toxicity...Other evaluations will include pharmacokinetics and the relationship between mutations in the UGT1A1 genes and safety. This study aims to show that the results of the NAPOLI 3 study in the global population can be reproduced in the Japanese population.Clinical trials registration: NCT06225999 (clinicaltrials.gov); jRCT2031230733 (Japanese clinical trials registry).
    P2 data • Journal
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • levoleucovorin calcium
    27d
    Identification of patients with advanced pancreatic cancer who might benefit from third-line chemotherapy. (PubMed, World J Gastrointest Oncol)
    This study identified that patients with good PS, CA19-9 < 1000 U/mL, second-line chemotherapy ≥ 19 weeks, and no peritoneal seeding before starting third-line treatment may benefit more from third-line chemotherapy.
    Journal
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    1m
    NALIRIFOX Before Surgery for the Treatment of Borderline Resectable Pancreatic Ductal Adenocarcinoma, Nectar Trial (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Roswell Park Cancer Institute
    New P2 trial
    |
    oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • fluorouracil topical
    1m
    Liposomal Irinotecan and Veliparib in Treating Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=18, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed
    Trial completion
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    veliparib (ABT-888) • Onivyde (nanoliposomal irinotecan)
    1m
    Perioperative NALIRIFOX in Resectable Pancreatic Adenocarcinoma: Randomized Phase II Trial (clinicaltrials.gov)
    P2, N=84, Recruiting, Taichung Veterans General Hospital
    New P2 trial
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    1m
    A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC) (clinicaltrials.gov)
    P2, N=134, Recruiting, Belgian Group of Digestive Oncology | Trial primary completion date: Jun 2025 --> Dec 2026
    Trial primary completion date
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    1m
    PANCONVA: Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=21, Recruiting, University of Kansas Medical Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • onvansertib (PCM-075) • Onivyde (nanoliposomal irinotecan)
    2ms
    NCI-2018-02122: Liposomal Irinotecan, Fluorouracil and Leucovorin in Treating Patients With Refractory Advanced High Grade Neuroendocrine Cancer of Gastrointestinal, Unknown, or Pancreatic Origin (clinicaltrials.gov)
    P2, N=11, Terminated, Roswell Park Cancer Institute | Trial completion date: Jun 2026 --> Aug 2024 | Active, not recruiting --> Terminated; low accrual
    Trial completion date • Trial termination
    |
    leucovorin calcium • Onivyde (nanoliposomal irinotecan) • fluorouracil topical
    2ms
    NASOX: Liposomal Irinotecan, S-1, and Oxaliplatin in Advanced Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=40, Completed, Asan Medical Center | Active, not recruiting --> Completed
    Trial completion
    |
    oxaliplatin • Teysuno (gimeracil/oteracil/tegafur) • Onivyde (nanoliposomal irinotecan)
    2ms
    NEO-Nal- IRI: A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P2, N=45, Active, not recruiting, University of Florida | Trial completion date: Dec 2024 --> Jul 2025
    Trial completion date
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    2ms
    Phase II Study of Nanoliposomal Irinotecan (Nal-IRI) with 5-Fluorouracil and Leucovorin in Refractory Advanced High-Grade Neuroendocrine Cancer of Gastroenteropancreatic (GEP) or Unknown Origin. (PubMed, Cancers (Basel))
    Nal-IRI with 5-FU/LV is a safe and effective treatment for refractory high-grade NECs of GEP or unknown origin. Future studies should explore novel combinations with Nal-IRI in high-grade NECs both in frontline and refractory settings.
    P2 data • Journal
    |
    TP53 (Tumor protein P53) • APC (APC Regulator Of WNT Signaling Pathway) • CHEK2 (Checkpoint kinase 2) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    TP53 mutation • CHEK2 mutation
    |
    5-fluorouracil • etoposide IV • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    2ms
    CLARITY-PanTumor01: AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 (clinicaltrials.gov)
    P2, N=190, Recruiting, AstraZeneca | N=123 --> 190 | Trial primary completion date: May 2025 --> Dec 2025
    Enrollment change • Trial primary completion date
    |
    CLDN18 (Claudin 18)
    |
    gemcitabine • 5-fluorouracil • leucovorin calcium • sonesitatug vedotin (AZD0901) • Onivyde (nanoliposomal irinotecan)
    2ms
    OESIRI: Nal-iri/lv5-fu Versus Paclitaxel as Second Line Therapy in Patients With Metastatic Oesophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=106, Completed, Federation Francophone de Cancerologie Digestive | Active, not recruiting --> Completed | Trial completion date: Apr 2025 --> Sep 2024 | Trial primary completion date: Nov 2024 --> Apr 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    paclitaxel • Onivyde (nanoliposomal irinotecan)
    2ms
    Onvansertib in Combination with Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants with Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P2, N=43, Completed, Cardiff Oncology | Active, not recruiting --> Completed
    Trial completion
    |
    5-fluorouracil • leucovorin calcium • onvansertib (PCM-075) • Onivyde (nanoliposomal irinotecan)
    2ms
    TAS102 in Combination With NAL-IRI in Advanced GI Cancers (clinicaltrials.gov)
    P1/2, N=64, Active, not recruiting, Emory University | Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2024 --> Jun 2025
    Enrollment closed • Trial primary completion date
    |
    Lonsurf (trifluridine/tipiracil) • Onivyde (nanoliposomal irinotecan)
    2ms
    NET-02: Second-line Therapy for Patients With Progressive Poorly Differentiated Extra-pulmonary Neuroendocrine Carcinoma (clinicaltrials.gov)
    P2, N=58, Completed, The Christie NHS Foundation Trust | Trial completion date: Dec 2023 --> Nov 2024 | Trial primary completion date: Dec 2023 --> Nov 2024 | Active, not recruiting --> Completed | N=102 --> 58
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    2ms
    NET-02: Second-line Therapy for Patients With Progressive Poorly Differentiated Extra-pulmonary Neuroendocrine Carcinoma (clinicaltrials.gov)
    P2, N=58, Completed, The Christie NHS Foundation Trust | Active, not recruiting --> Completed | N=102 --> 58 | Trial completion date: Dec 2023 --> Nov 2024 | Trial primary completion date: Dec 2023 --> Nov 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    3ms
    FW-2020-1: A Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=79, Completed, Famewave Ltd. | Active, not recruiting --> Completed | Trial completion date: Jan 2025 --> Sep 2024
    Trial completion • Trial completion date
    |
    Opdivo (nivolumab) • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • Onivyde (nanoliposomal irinotecan) • CM24
    3ms
    Liposomal Irinotecan and Veliparib in Treating Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, National Cancer Institute (NCI) | N=48 --> 18 | Trial completion date: Jul 2024 --> Dec 2025
    Enrollment change • Trial completion date
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    veliparib (ABT-888) • Onivyde (nanoliposomal irinotecan)
    3ms
    Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P1/2, N=34, Completed, University of Michigan Rogel Cancer Center | Active, not recruiting --> Completed | Trial completion date: May 2025 --> Nov 2024 | Trial primary completion date: May 2025 --> Nov 2024
    Trial completion • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    UGT1A1*1*1
    |
    Opdivo (nivolumab) • 5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    3ms
    PANCONVA: A Phase 1b/2 Trial of Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=21, Not yet recruiting, University of Kansas Medical Center
    New P1/2 trial • Combination therapy • Metastases
    |
    5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • onvansertib (PCM-075) • Onivyde (nanoliposomal irinotecan)
    3ms
    Chemotherapy in Patients With Relapsed Small Cell Lung Cancer in Combination With Allopurinol and MycoPhenolate (CLAMP Trial) (clinicaltrials.gov)
    P1, N=17, Terminated, Washington University School of Medicine | Active, not recruiting --> Terminated; Futility
    Trial termination • Combination therapy
    |
    irinotecan • Onivyde (nanoliposomal irinotecan)
    4ms
    Onvansertib in Combination with Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants with Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P2, N=43, Active, not recruiting, Cardiff Oncology | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    5-fluorouracil • leucovorin calcium • onvansertib (PCM-075) • Onivyde (nanoliposomal irinotecan)
    4ms
    Chemotherapy in Patients With Relapsed Small Cell Lung Cancer in Combination With Allopurinol and MycoPhenolate (CLAMP Trial) (clinicaltrials.gov)
    P1, N=17, Active, not recruiting, Washington University School of Medicine | Recruiting --> Active, not recruiting | Phase classification: P1/2 --> P1 | N=36 --> 17 | Trial completion date: Jun 2026 --> Nov 2024 | Trial primary completion date: Dec 2025 --> Nov 2024
    Enrollment closed • Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    irinotecan • Onivyde (nanoliposomal irinotecan)
    4ms
    A Multi-center, Single-arm, Prospective Non-interventional Study to Investigate the Safety Profiles and Effectiveness of Liposomal Irinotecan (ONIVYDE®) in Combination with 5-fluorouracil (5-FU) and Leucovorin (LV) in Chinese Patients with Metastatic Pancreatic Cancer As Approval Condition (SEOPAC) (clinicaltrials.gov)
    P=N/A, N=120, Not yet recruiting, Servier (Tianjin) Pharmaceutical Co. LTD.
    New trial
    |
    5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    4ms
    To evaluate the efficacy and safety of NALIRIFOX combined with adbelimumab in the first-line treatment of unresectable locally advanced or metastatic biliary tract malignancies (ChiCTR2400089696)
    P2, N=27, Not yet recruiting, West China Hospital of Sichuan University; West China Hospital of Sichuan University
    New P2 trial • Metastases
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • Ariely (adebrelimab)
    4ms
    A Study of Liposomal Irinotecan (Nal-IRI) with 5 Fluorouracil, leucovorin, and Oxaliplatin (NALIRIFOX) in patients with locally advanced Pancreatic Cancer (ChiCTR2400089619)
    P2, N=20, Recruiting, Jiangsu Province Hospital; Jiangsu Province Hospital
    New P2 trial • Metastases
    |
    5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • Teysuno (gimeracil/oteracil/tegafur) • Onivyde (nanoliposomal irinotecan)
    5ms
    NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX as Conversion Therapy of Locally Advanced Pancreatic Cancer (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    New P2 trial
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    5ms
    Nal-IRI/5-FU/LV Chemotherapy Combined with PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT As Second-line Therapy in Metastatic Pancreatic Cancer Patients (clinicaltrials.gov)
    P2, N=56, Not yet recruiting, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    New P2 trial • IO biomarker • Metastases
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • IL10 (Interleukin 10) • IL17A (Interleukin 17A) • IFNA1 (Interferon Alpha 1) • IL1B (Interleukin 1, beta)
    |
    5-fluorouracil • Focus V (anlotinib) • Andewei (benmelstobart) • Onivyde (nanoliposomal irinotecan)
    5ms
    Small-Molecule Therapeutics Achieve Multiple Mechanism-Mediated Sensitizations of Colorectal Cancer to Immune Checkpoint Blockade via Neutrophil Micropharmacies. (PubMed, Nano Lett)
    This study confirmed the potential of combining immunogenic cell death (ICD) inducer irinotecan (IRI) and transforming growth factor-β (TGF-β) inhibitor galunisertib (GAL) to improve tumor immunogenicity and remodel the immunosuppressive TME. Moreover, to ameliorate the in vivo delivery barriers associated with small molecules, neutrophil micropharmacies (NOG) were developed for the codelivery of IRI and GAL, which loaded the commercial liposome formulation of IRI (ONIVYDE, ONI) intracellularly and conjugated the pH-responsive GAL liposome (GLP) on the cell surface. This neutrophil-based formulation resulted in a >4-fold increase in the ratios of the amount of both IRI and GAL accumulated in tumors to the dosage administration, effectively achieving multiple mechanism-mediated sensitization of CRC to ICB therapy.
    Journal • Checkpoint inhibition • Checkpoint block
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    irinotecan • Onivyde (nanoliposomal irinotecan) • galunisertib (LY2157299)
    5ms
    Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=173, Recruiting, Hebei Medical University Fourth Hospital | Not yet recruiting --> Recruiting | N=50 --> 173 | Trial completion date: Dec 2025 --> Mar 2027 | Trial primary completion date: Dec 2024 --> Feb 2026
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    Avastin (bevacizumab) • 5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    6ms
    To explore the efficacy and safety of nanoliposomal irinotecan combined with oxaliplatin and fluorouracil neoadjuvant therapy for locally advanced rectal cancer (ChiCTR2400088276)
    P=N/A, N=44, Not yet recruiting, Cancer Hospital Affiliated of Shandong First Medical University; Cancer Hospital Affiliated of Shandong First Medical University
    New trial • Metastases
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    6ms
    Nanoliposomal irinotecan in combination with Cadonilimab in patients with second line extensive-stage small cell lung cancer: a phase II study (ChiCTR2400087003)
    P2, N=30, Recruiting, Cancer Hospital Affiliated of Shandong First Medical University; Cancer Hospital Affiliated of Shandong First Medical University
    New P2 trial • Combination therapy
    |
    Kaitanni (cadonilimab) • Onivyde (nanoliposomal irinotecan)
    6ms
    NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer (clinicaltrials.gov)
    P2, N=44, Recruiting, Georgetown University | Trial completion date: Jul 2024 --> Dec 2025 | Trial primary completion date: May 2024 --> Apr 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    CD4 (CD4 Molecule)
    |
    5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    7ms
    COMBAT: Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients (clinicaltrials.gov)
    P2, N=80, Completed, BioLineRx, Ltd. | Phase classification: P2a --> P2
    Phase classification • Metastases
    |
    Keytruda (pembrolizumab) • 5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • Aphexda (motixafortide)
    7ms
    Neoadjuvant Chemoradiation With Nal-IRI and Capecitabine Guided by UGT1A1 Status in Patients With Rectal Cancer (clinicaltrials.gov)
    P2, N=60, Recruiting, Hebei Medical University Fourth Hospital | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    capecitabine • Onivyde (nanoliposomal irinotecan)
    7ms
    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, Active, not recruiting, Institut de Recherches Internationales Servier | Not yet recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • levoleucovorin calcium
    7ms
    Chemotherapy in Patients With Relapsed Small Cell Lung Cancer in Combination With Allopurinol and MycoPhenolate (CLAMP Trial) (clinicaltrials.gov)
    P1/2, N=36, Recruiting, Washington University School of Medicine | Trial completion date: Oct 2025 --> Jun 2026 | Trial primary completion date: Apr 2025 --> Dec 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    irinotecan • Onivyde (nanoliposomal irinotecan)