A Study to Compare Onivyde Manufactured at Two Different Production Sites in Adult Participants With Advanced Cancer in the Pancreas

Exclusion Criteria

• •Have only localised advanced disease.
• •History of any second malignancy in the last 2 years.
• •Known history of central nervous system metastases
• •Clinically significant gastrointestinal disorder including hepatic disorders, bleeding, inflammation, occlusion, diarrhoea \>Grade 1, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease or partial bowel obstruction.
• •Concurrent illnesses that would be a relative contraindication to trial participation such as active cardiac or liver disease
• •Active infection or an unexplained fever \>38.5°C on the first scheduled day of dosing
• •Neuroendocrine tumour (carcinoid, islet cell) or acinar pancreatic carcinoma
• •History of interstitial lung disease, history of slowly progressive dyspnoea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.
• •Exposure to a non-liposomal irinotecan or SN-38 based regimen within 4 weeks prior to randomisation, or exposure to Onivyde or other irinotecan based liposomal products within 6 weeks prior to randomisation
• •Major surgery, other than diagnostic surgery, within 4 weeks prior to randomisation
• •Participants who have received a live vaccine within 4 weeks prior to randomisation.
• •Use of strong CYP3A inhibitors or inducers, or strong inhibitors of UGT1A1.
• •Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to study intervention on Cycle 1 Day 1
• •Known low or absent dihydropyrimidine dehydrogenase (DPD) activity.
• •Homozygous for the UGT1A1\*28 allele.
• •Known hypersensitivity to any of the components of Onivyde injection, other liposomal products, or any components of 5-FU, or LV
• •Presence of any contraindications outlined in the Contraindications or Warnings and Precautions sections of the IB for Onivyde, or in the prescribing information for 5-FU or LV.
• •Participants who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening
• •Any other medical or social condition deemed by the investigator to be likely to interfere with a participant's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results