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Onivyde

DRUG6 trials

Sponsors

Bristol-Myers Squibb, Institut de Recherches Internationales Servier, Changhoon Yoo, Benaroya Research Institute, Federation Francophone de Cancerologie Digestive

Conditions

Advanced Pancreatic CancerMetastatic Biliary Tract CancerMetastatic Pancreatic CancerPancreatic AdenocarcinomaRecurrent Ewing SarcomaRecurrent HepatoblastomaRecurrent Malignant Germ Cell TumorRecurrent Malignant Solid Neoplasm

Phase 1

Alternative Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer
NCT03703063
Benaroya Research InstitutePancreatic Adenocarcinoma
Start: 2018-09-17End: 2022-09-17Target: 30Updated: 2021-01-27
Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma
RecruitingNCT04901702
St. Jude Children's Research HospitalRecurrent Ewing Sarcoma, Recurrent Hepatoblastoma, Recurrent Malignant Germ Cell Tumor +19
Start: 2021-06-09End: 2026-12-31Target: 90Updated: 2026-02-09

Phase 2

A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
CompletedNCT03336216
Bristol-Myers SquibbAdvanced Pancreatic Cancer
Start: 2017-12-18End: 2023-06-01Updated: 2024-07-23
Nal-IRI(Nanoliposomal Irinotecan) Plus 5-FU/LV in Metastatic Biliary Tract Cancer
CompletedNCT03524508
Changhoon YooMetastatic Biliary Tract Cancer
Start: 2018-09-04End: 2021-12-31Updated: 2022-08-24
Nal-iri/lv5-fu Versus Paclitaxel as Second Line Therapy in Patients With Metastatic Oesophageal Squamous Cell Carcinoma
CompletedNCT03719924
Federation Francophone de Cancerologie DigestiveSquamous Cell Carcinoma
Start: 2019-03-07End: 2024-09-29Updated: 2025-01-08

Unknown Phase

Post Marketing Surveillance Study for ONIVYDE® in South Korea
CompletedNCT03446872
Institut de Recherches Internationales ServierMetastatic Pancreatic Cancer
Start: 2018-03-08End: 2020-08-29Updated: 2021-09-28

Related Papers

Alternating neoadjuvant gemcitabine-nab-paclitaxel (GnP) and nal-irinotecan, 5-fluorouracil and folinic acid (nal-IRI) regimens in resectable (R) and borderline resectable (BR) pancreatic cancer (PC): A pilot study.
Journal of Clinical Oncology2026-01-10
Nal-IRI/LV5-FU versus paclitaxel as second-line therapy in patients with metastatic esophageal squamous cell carcinoma (PRODIGE 62-FFCD 1701-OESIRI)
European Journal of Cancer2025-08-22
ONITT: A phase I study of nanoliposomal irinotecan with talazoparib or temozolomide in children and young adults with recurrent or refractory solid tumors.
Journal of Clinical Oncology2025-05-28
Liposomal irinotecan for previously treated patients with biliary tract cancer: A pooled analysis of NIFTY and NALIRICC trials.
2025-03-253 citations
Second-Line Fluoropyrimidine-Based Chemotherapy in Advanced Biliary Tract Cancer: A Meta-analysis Based on Individual Patient-Level Data of Randomized Trials.
2024-10-17
Treatment With Liposomal Irinotecan Plus Fluorouracil and Leucovorin for Patients With Previously Treated Metastatic Biliary Tract Cancer
JAMA Oncology2023-03-2371 citations
ARRY-382 in Combination with Pembrolizumab in Patients with Advanced Solid Tumors: Results from a Phase 1b/2 Study
Clinical Cancer Research2022-03-1847 citations
Liposomal irinotecan plus fluorouracil and leucovorin versus fluorouracil and leucovorin for metastatic biliary tract cancer after progression on gemcitabine plus cisplatin (NIFTY): a multicentre, open-label, randomised, phase 2b study.
2021-10-14154 citations
GB1275, a first-in-class CD11b modulator: rationale for immunotherapeutic combinations in solid tumors.
2021-08-0136 citations
Liposomal irinotecan (nal-IRI) in combination with fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic biliary tract cancer (BTC) after progression on gemcitabine plus cisplatin (GemCis): Multicenter comparative randomized phase 2b study (NIFTY).
Journal of Clinical Oncology2021-05-2027 citations
A randomized phase II study of cabiralizumab (cabira) + nivolumab (nivo) ± chemotherapy (chemo) in advanced pancreatic ductal adenocarcinoma (PDAC).
Journal of Clinical Oncology2019-01-2949 citations
Pharmacodynamics (PD) and genomic profiling of pts treated with cabiralizumab (cabira) + nivolumab (NIVO) provide evidence of on-target tumor immune modulations and support future clinical applications.
Journal of Clinical Oncology2018-05-2014 citations