Onivyde (nanoliposomal irinotecan) / Ipsen, Servier, Yakult Honsha, Takeda, PharmaEngine 
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40 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Onivyde (nanoliposomal irinotecan) / Servier, Ipsen
RESILIENT, NCT03088813 / 2017-004261-26: Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer

Completed
3
491
Europe, US, RoW
Irinotecan liposome injection, ONIVYDE®, Topotecan
Ipsen
Small Cell Lung Cancer
02/22
07/23
PREDICT, NCT03468335 / 2016-005147-17: 2nd-line Therapy With Nal-IRI After Gem/Nab-pac in Advanced Pancreatic Cancer - Predictive Role of 1st-line Therapy

Active, not recruiting
3
270
Europe
Irinotecan Liposomal Injection [Onivyde], Nal-IRI
AIO-Studien-gGmbH, Crolll Gmbh, Servier Deutschland GmbH
Locally Advanced Pancreatic Cancer, Metastatic Pancreatic Cancer
05/22
05/23
NAPOLI-3, NCT04083235 / 2018-003585-14: 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

Active, not recruiting
3
770
Europe, Canada, US, RoW
Irinotecan Liposomal Injection, Onivyde®, Nal-IRI, Oxaliplatin, Eloxatin®, 5Fluorouracil, Adrucil®, flurouracil, 5-FU, Leucovorin, Folinic Acid, Nab-paclitaxel, Abraxane®, Gemcitabine, Gemzar®
Ipsen
Metastatic Adenocarcinoma of the Pancreas
07/22
12/24
2017-000345-46: Study with anti cancer drugs in patients with resectable parcreatic cancer ¿nITRo trial" Studio con farmaci anti tumorali in pazienti con tumore del pancreas resecabile ¿studio nITRo¿

Not yet recruiting
2
67
Europe
oxaliplatino, 5-fluorouracile, lederfolin, Solution for infusion, Powder for solution for infusion, ONIVYDE, OXALIPLATINO ACCORD - 5 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 40 ML, FLUOROURACILE TEVA - 5 G/100 ML SOLUZIONE PER INFUSIONE 1 FLACONCINO DA 100 ML, LEDERFOLIN - 100 MG POLVERE PER SOLUZIONE PER INFUSIONE 1 FLACONCINO
CENTRO RICERCHE CLINICHE DI VERONA, Baxalta GmbH
Resectable pancreatic cancer Tumore pancreatico resecabile, Resectable pancreatic cancer tumore del pancreas resecabile, Diseases [C] - Cancer [C04]
 
 
2017-003496-54: A multicenter randomized phase II study to determine the optimal first-line chemotherapy regimen in patients with metastatic pancreatic cancer (FOOTPATH) Eine randomisierte Multicenterstudie der Phase II zur Ermittlung des optimalen Chemotherapie-Regimes in der Erstlinientherapie von Patienten mit einem metastasierten Pankreaskarzinom

Not yet recruiting
2
270
Europe
5-Fluorouracil, Folinic Acid, Oxaliplatin, Gemcitabine, Nab-Paclitaxel, Concentrate for solution for infusion, Infusion, Onivyde
University Hospital, LMU Munich (Germany), Shire International
Histologically (not cytologically) confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma (PDAC) [Stage IV according to UICC TNM edition 8 of 201622: each T, each N, M1] Histologisch (nicht zytologisch) bestätigte Diagnose eines metastasierten duktalen Adenokarzinoms des Pankreas (PDAC) [Stadium IV der UICC TNM Edition 8 von 2016 : jedes T, jedes N, M1], Metastatic pancreatic adenocarcinoma Metastasiertes Adenokarzinom des Pankreas, Diseases [C] - Cancer [C04]
 
 
2017-004730-28: clinical study for patients with metastatic oesophagus carcinoma étude clinique pour les patients avec un cancer de l’œsophage métastatique

Not yet recruiting
2
106
Europe
TAXOL, Solution for infusion, Solution for injection, Solution for solution for infusion, ONIVYDE, Fluorouracile Ebewe, ELVORINE, taxol
fédération francophone de cancérologie digestive, SHIRE
METASTATIC OESOPHAGEAL SQUAMOUS CELL CARCINOMA METASTATIC OESOPHAGEAL SQUAMOUS CELL CARCINOMA, carcinome épidermoïde de l'oesophage carcinome épidermoïde de l'oesophage, Diseases [C] - Cancer [C04]
 
 
2019-002734-37: Open-Label, Single Arm Phase II Trial Investigating the Efficacy, Safety and Quality of Life of Neoadjuvant Chemotherapy with Liposomal Irinotecan Combined with Oxaliplatin and 5-Fluorouracil/Folinic Acid Followed by Curative Surgical Resection in Patients with Hepatic Oligometastatic Adenocarcinoma of the Pancreas (HOLIPANC) Offene, einarmige Phase II klinische Studie zur Wirksamkeit, Sicherheit und Lebensqualität einer neoadjuvanten Chemotherapie aus liposomalem Irinotecan kombiniert mit Oxaliplatin und 5-Fluorouracil/Folinsäure, gefolgt von kurativer Resektion bei Patienten mit auf die Leber beschränktem oligometastatischen Adenokarzinom des Pankreas (HOLIPANC)

Not yet recruiting
2
150
Europe
Oxaliplatin, Folinic Acid, 5-Fluorouracil, Concentrate for solution for infusion, Concentrate and solvent for solution for infusion, Solution for infusion, Onivyde
University of Cologne, SERVIER (Les Laboratoires Servier, France)
Hepatic Oligometastatic Adenocarcinoma of the Pancreas Auf die Leber beschränktes oligometastatisches Adenokarzinom des Pankreas, Hepatic Oligometastatic Adenocarcinoma of the Pancreas Auf die Leber beschränktes oligometastatisches Adenokarzinom des Pankreas, Diseases [C] - Cancer [C04]
 
 
AIO-NIFE-trial, NCT03044587 / 2016-002467-34: Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Biliary-tract Cancer

Active, not recruiting
2
93
Europe
Arm NaI-IRI + 5-FU + Leucovorin (Arm A), Arm Cisplatin + Gemcitabine (Arm B)
AIO-Studien-gGmbH, Servier, Institut für Klinisch-Onkologische Forschung der Krankenhaus Nordwest GmbH
Adenocarcinoma Metastatic, Biliary Tract Cancer, Adenocarcinoma of the Biliary Tract, Adenocarinoma Locally Advanced, Non-Resectable Hepatocellular Carcinoma, Intrahepatic Bile Duct Carcinoma, Extrahepatic Bile Duct Carcinoma
01/22
01/25
NCI-2018-02122, NCT03736720: Liposomal Irinotecan, Fluorouracil and Leucovorin in Treating Patients With Refractory Advanced High Grade Neuroendocrine Cancer of Gastrointestinal, Unknown, or Pancreatic Origin

Active, not recruiting
2
11
US
Fluorouracil, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757, Leucovorin, Folinic acid, Liposomal Irinotecan, Irinotecan Liposome, MM-398, nal-IRI, Nanoliposomal Irinotecan, Nanoparticle Liposome Formulation of Irinotecan, Onivyde, PEP02, Quality-of-Life Assessment, Quality of Life Assessment
Roswell Park Cancer Institute, Ipsen
Locally Advanced Digestive System Neuroendocrine Carcinoma, Locally Advanced Pancreatic Neuroendocrine Carcinoma, Metastatic Digestive System Neuroendocrine Carcinoma, Metastatic Pancreatic Neuroendocrine Carcinoma, Refractory Digestive System Neuroendocrine Carcinoma, Refractory Pancreatic Neuroendocrine Carcinoma, Unresectable Digestive System Neuroendocrine Carcinoma, Unresectable Pancreatic Neuroendocrine Carcinoma
10/22
06/26
NCT03336216 / 2018-000339-28: A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer

Checkmark From trial in combination trial with cabiralizumab in advanced pancreatic cancer
Feb 2020 - Feb 2020: From trial in combination trial with cabiralizumab in advanced pancreatic cancer
Completed
2
205
Europe, Canada, Japan, US, RoW
Cabiralizumab, BMS-986227, FPA008, Nab-paclitaxel, Abraxane, Onivyde, irinotecan liposome, Nivolumab, Opdivo, BMS-936558, Fluorouracil, 5-Fluorouracil, Gemcitabine, Oxaliplatin, Leucovorin, Irinotecan Hydrochloride
Bristol-Myers Squibb
Advanced Pancreatic Cancer
06/23
06/23
NEO-Nal- IRI, NCT03483038: 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

Active, not recruiting
2
45
US
Liposomal Irinotecan, ONIVYDE, FOLFOX regimen
University of Florida, Ipsen
Pancreatic Adenocarcinoma
09/23
12/24
NCT03861702: Liposomal Irinotecan in Combination With Oxaliplatin, Leucovorin, and 5-fluorouracil for Patients With Locally Advanced Pancreatic Carcinoma:

Active, not recruiting
2
28
US
FOLFOX regimen, Liposomal Irinotecan, nal-Irinotecan
Nelson Yee, Ipsen
Locally Advanced Pancreatic Carcinoma(LAPC)
08/23
08/24
NAPOLI-2, NCT04005339: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer

Recruiting
2
44
US
Nanoliposomal Irinotecan, Leucovorin, Fluorouracil
Georgetown University, Ipsen
Advanced Biliary Tract Cancer
04/25
12/25
NET-02, NCT03837977: Second-line Therapy for Patients With Progressive Poorly Differentiated Extra-pulmonary Neuroendocrine Carcinoma

Active, not recruiting
2
102
Europe
Liposomal Irinotecan, Onivyde, Fluorouracil, Folinic Acid, Docetaxel
The Christie NHS Foundation Trust, University of Leeds, Servier, National Institute for Health Research, United Kingdom
Oncology, Neuroendocrine Carcinoma
12/23
12/23
NCT04656041: Folfox+Irinotecan+Chemort In Esophageal Cancer

Recruiting
2
40
US
FOLFOX/ nal-IRI, Paclitaxel, Abraxane®., Carboplatin, Paraplatin, Proton Radiation Therapy
Massachusetts General Hospital, Ipsen
Gastroesophageal Junction Adenocarcinoma, Esophagogastric Cancer
12/23
12/27
CLARITY-PanTumor01, NCT06219941: AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

Recruiting
2
123
Europe, Canada, Japan, US, RoW
AZD0901, CMG901, 5-Fluorouracil, 5-FU, Leucovorin, LV, l-leucovorin, I-LV, Irinotecan, Camptosar, Nanoliposomal Irinotecan, ONIVYDE, Gemcitabine, Gemzar
AstraZeneca
Gastric Cancer, Gastroesophageal Junction Cancer, Pancreatic Adenocarcinoma
05/25
01/27
NCT06345300: NALIRIFOX in Combination With Camrelizumab for BRPC: a Prospective, Exploratory Study

Recruiting
2
40
RoW
Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab, NALIRIFOX+PD-1, Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate, NALIRIFOX
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Jiangsu HengRui Medicine Co., Ltd.
Borderline Resectable Pancreatic Cancer
12/24
12/25
NCT04752696: Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal Adenocarcinoma

Active, not recruiting
2
43
US
Onvansertib, PCM-075, Nanoliposomal irinotecan, Onivyde, Nal-IRI, Leucovorin, Fluorouracil, 5-FU
Cardiff Oncology
Pancreatic Ductal Adenocarcinoma
03/24
03/24
OESIRI, NCT03719924: Nal-iri/lv5-fu Versus Paclitaxel as Second Line Therapy in Patients With Metastatic Oesophageal Squamous Cell Carcinoma

Active, not recruiting
2
106
Europe
Onivyde, no other intervention name to add, Paclitaxel
Federation Francophone de Cancerologie Digestive, Shire
Squamous Cell Carcinoma
11/24
04/25
LyRICX, NCT03764553: Liposomal iRInotecan, Carboplatin or oXaliplatin for Esophagogastric Cancer

Recruiting
2
320
Europe
Liposomal Irinotecan, Carboplatin, Capecitabine, Xeloda, Oxaliplatin, 5-fluorouracil, Leucovorin
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Servier
Esophageal Cancer
07/25
07/26
HOLIPANC, NCT04617457: Chemotherapy and Surgical Resection in Patients With Hepatic Oligometastatic Adenocarcinoma of the Pancreas

Recruiting
2
150
Europe
nal-irinotecan (nal-iri) (Onyvide), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA), nal-irinotecan (nal-iri), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA), ONIVYDE TM
University of Cologne, Servier
Pancreatic Cancer, Metastasis, Surgery, Oligometastatic Disease
12/24
09/25
NCI-2019-07966, NCT04150640: Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma

Recruiting
2
52
US
Nal-IRI, liposomal irinotecan, Oxaliplatin, 5-FU, Fluorouracil, Trastuzumab, Pembrolizumab, Nivolumab
University of Wisconsin, Madison, Ipsen
Esophageal Adenocarcinoma, Gastric Adenocarcinoma
12/25
12/26
NCT05851924: A Study of NALIRIFOX in Combination With Radiation Therapy in People With Pancreatic Ductal Adenocarcinoma (PDAC)

Recruiting
2
60
US
NALIRIFOX, AD-XRT and Capecitabine
Memorial Sloan Kettering Cancer Center, Ipsen, Pancreatic Cancer Research Fund
Pancreatic Ductal Adenocarcinoma
05/26
05/26
NCT05854498: Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer

Recruiting
2
25
US
Liposomal irinotecan, TAS102, Bevacizumab
University of Wisconsin, Madison, Ipsen
Metastatic Colorectal Cancer
07/26
07/26
OPTIMUS, NCT04901741: Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or Gemcitabine/Nab-Paclitaxel in MSS Pancreatic Cancer

Not yet recruiting
2
60
NA
Olaptesed pegol, NOX-A12, Pembrolizumab, KEYTRUDA®
TME Pharma AG, Merck Sharp & Dohme LLC
Metastatic Pancreatic Cancer
10/27
10/28
NCT05255666: Combination Liposomal Irinotecan and Pembrolizumab For Triple-Negative Breast Cancer (TNBC) With Brain Metastases (BM)

Withdrawn
2
42
NA
Pembrolizumab, Keytruda, Liposomal Irinotecan, NaI-IRI
Washington University School of Medicine, Merck Sharp & Dohme LLC, Ipsen
Triple Negative Breast Cancer, Brain Metastases
01/27
01/30
NCT05251038: Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer

Withdrawn
1/2
59
US
Sotorasib, Lumakras, Liposomal Irinotecan (nal-IRI), Onivyde, 5 Fluorouracil (5FU), Leucovorin (LV), Gemcitabine (GEM), Nab paclitaxel, Abraxane
Devalingam Mahalingam, Amgen
Pancreatic Cancer, Unresectable Pancreatic Cancer, Metastatic Pancreatic Cancer, KRAS P.G12C
01/23
01/23
1-BETTER, NCT04825288: XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer

Completed
1/2
76
US
XB2001 or Placebo
XBiotech, Inc.
Pancreatic Cancer
10/23
06/24
NCT03368963: TAS102 in Combination With NAL-IRI in Advanced GI Cancers

Recruiting
1/2
64
US
Nanoliposomal Irinotecan, Irinotecan Liposome, Onivyde, PEP02, Camptosar, Liposomal Irinotecan, Trifluridine and Tipiracil Hydrochloride, Lonsurf, TAS-102, Trifluridine/Tipiracil
Emory University, Taiho Oncology, Inc., Ipsen
Colorectal Adenocarcinoma, Gastric Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Non-Resectable Cholangiocarcinoma, Stage IV Colorectal Cancer, Stage IV Gastric Cancer, Stage IV Pancreatic Cancer, Stage IVA Colorectal Cancer, Stage IVB Colorectal Cancer, Stage III Colorectal Cancer, Stage III Gastric Cancer, Stage III Pancreatic Cancer, Unresectable Digestive System Adenocarcinoma, Unresectable Pancreatic Carcinoma
11/24
11/25
FW-2020-1, NCT04731467: A Study of CM24 in Combination With Nivolumab in Adults With Advanced Solid Tumors

Checkmark Presentation of data in combination with CM24 for solid tumors at AACR 2022
Apr 2022 - Apr 2022: Presentation of data in combination with CM24 for solid tumors at AACR 2022
Checkmark Initiation of trial in combination with Opdivo for NSCLC
Feb 2021 - Feb 2021: Initiation of trial in combination with Opdivo for NSCLC
Active, not recruiting
1/2
79
Europe, US, RoW
CM-24 and Nivolumab - Dose Escalation, CM-24, Nivolumab, Nab paclitaxel and Gemcitabine - Expansion, CM-24, Nivolumab, and Nal-IRI/5-FU/LV - Expansion, Nivolumab, Nab paclitaxel and Gemcitabine - Expansion, Nivolumab and Nal-IRI/5-FU/LV - Expansion
Famewave Ltd., Bristol-Myers Squibb
Solid Tumor, Non Small Cell Lung Cancer, Pancreatic Cancer, Ovarian Cancer, Papillary Thyroid Cancer, Melanoma, Colorectal Adenocarcinoma
12/24
01/25
Phoenix, jRCTs031210040: Phase 1/2 study of Onivyde, nanoliposomal-irinotecan plus S-1 in metastatic or recurrent pancreatic cancer after first-line gemcitabine-based therapy

Active, not recruiting
1/2
68
Japan
Onivyde (nanoliposomal irinotecan) - Servier, Ipsen
National Cancer Center Hospital East, Nihon Servier Co.,Ltd.
Metastatic or recurrent pancreatic cancer
 
 
NCT03785873: Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer

Active, not recruiting
1/2
34
US
Nivolumab, Opdivo®, BMS-936558, MDX-1106, ONO-4538, Nanoliposomal-Irinotecan, Onivyde®, 5-Fluorouracil, 5-FU, Leucovorin
University of Michigan Rogel Cancer Center, Ipsen, Bristol-Myers Squibb
Biliary Tract Cancer
05/25
05/25
NCT04901702 / 2021-003570-31: Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma

Active, not recruiting
1/2
46
Canada, US
Onivyde, Nanoliposomal irinotecan, Talazoparib, BMN 673, Talzenna, Temozolomide, Temodar, Temodal
St. Jude Children's Research Hospital, Pfizer, Ipsen
Recurrent Solid Tumor, Recurrent Ewing Sarcoma, Recurrent Hepatoblastoma, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Solid Neoplasm, Recurrent Neuroblastoma, Recurrent Osteosarcoma, Recurrent Peripheral Primitive Neuroectodermal Tumor, Recurrent Rhabdoid Tumor, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Recurrent Wilms Tumor, Refractory Ewing Sarcoma, Refractory Hepatoblastoma, Refractory Malignant Germ Cell Tumor, Refractory Malignant Solid Neoplasm, Refractory Neuroblastoma, Refractory Osteosarcoma, Refractory Peripheral Primitive Neuroectodermal Tumor, Refractory Rhabdoid Tumor, Refractory Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma
12/25
12/25
NCT02022644: Study of Convection-Enhanced, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma

Completed
1
18
US
nanoliposomal irinotecan, MM-398, ONIVYDE
University of California, San Francisco, Ipsen, National Cancer Institute (NCI)
High Grade Glioma
12/20
05/23
NCT03810742: Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE®) in Combination With TAS-102 (LONSURF®) in Refractory Solid Tumors

Completed
1
44
RoW
Nanoliposomal Irinotecan, TAS-102
PharmaEngine
Refractory Solid Tumors
05/22
10/23
NCT03554707: SGT-53 in Children With Recurrent or Progressive CNS Malignancies

Not yet recruiting
1
6
US
SGT-53, Radiation, Irinotecan, Camptosar, Onivyde, Temozolomide, Temodar, Bevacizumab, Avastin
SynerGene Therapeutics, Inc.
Childhood CNS Tumor
12/23
12/24
SIRACUSA, NCT05383352: A Study to Compare Onivyde Manufactured at Two Different Production Sites in Adult Participants With Advanced Cancer in the Pancreas

Active, not recruiting
1
177
Europe, RoW
Irinotecan liposome injection, Onivyde® Reference product, Onivyde Test product, Folinic Acid, Leucovorin (LV), 5-Fluorouracil, 5-FU
Ipsen
Metastatic Pancreatic Adenocarcinoma
05/24
09/24
NALIRI-PANC, NCT06006728: Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy

Completed
N/A
58
Europe
University Hospital, Bordeaux, Servier
Pancreatic Adenocarcinoma Metastatic
10/23
10/23
NALLONG, NCT06155136: RWE on Patients With mPDAC Long-term Survival After Treatment With Liposomal Irinotecan

Active, not recruiting
N/A
163
Europe
Servier Affaires Médicales
Pancreatic Cancer Metastatic
03/24
09/24
NCT05601323: A Study of Suizenji in Patients With Unresectable Pancreatic Cancer

Recruiting
N/A
90
Japan
Suizenji, Nal-IRI/FL, mFOLFIRINOX, Gem/nab-PTX
SONIRE Therapeutics Inc.
Unresectable Pancreatic Cancer
10/25
10/25

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