Phase 2 Pancreatic Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are willing and able to follow the study schedule, including attending all visits, treatments, and follow-up appointments
• People who have been diagnosed with pancreatic cancer (confirmed by biopsy) that has either spread to other parts of the body or cannot be surgically removed — note that people who have had prior surgery to remove a pancreatic tumour may only be considered if the cancer has come back in a way that allows for a specific procedure called EUS-RFA
• People who have the mental capacity to understand and agree to the study requirements
• People with a general health and activity level rated 0 to 2 on a standard scale used by doctors (ECOG scale), meaning they are able to carry out daily activities with no more than moderate limitations
• People who have at least one area of cancer spread that can be measured on a scan
• People who have not had prior chemotherapy or radiation for their advanced/metastatic pancreatic cancer, with some exceptions: prior treatment given after surgery (adjuvant therapy, including certain chemotherapy regimens) is allowed if it was completed at least 3 months before joining the study; people who started first-line chemotherapy for metastatic disease elsewhere and have had stable disease for up to 3 months (confirmed by imaging review at the study site) may also be considered
• People whose blood counts meet the required levels — specifically, a neutrophil count of at least 1 x 10⁹/L and a platelet count of at least 75 x 10⁹/L (confirm with trial site)
• People with albumin blood levels of at least 3 g/dL (a measure of nutrition and liver function)
• People whose bilirubin level (a liver-related blood marker) is below twice the normal upper limit — those with a condition called Gilbert's Syndrome or those who have had a bile duct stent placed may still be considered under certain conditions (confirm with trial site)
• People whose liver enzyme levels (ALT, AST, and ALP) are within acceptable ranges — up to 3 times the normal upper limit, or up to 5 times if the cancer has spread to the liver
• People whose kidneys are functioning at a sufficient level, measured by a creatinine clearance of at least 30 mL/minute
• People who have had major surgery under general anaesthesia must have had that surgery completed at least 4 weeks before starting the immunotherapy part of the study

Who may not be able to join:

• People who do not have a telephone number or a permanent home address
• People who are pregnant or breastfeeding, or people of reproductive potential who are not willing to use effective contraception from the time of screening until 90 days after the last study dose
• People who are currently inmates or prisoners
• People who are unable to give informed consent
• People whose pancreatic cancer is considered removable by surgery or is classified as "borderline resectable"
• People with a known history of cancer that has spread to the brain or central nervous system
• People with a history of another separate cancer — though some exceptions apply, such as certain treated skin cancers, carcinoma in situ with no signs of disease, or other cancers that are not currently active at stage 4 (confirm with trial site)
• People with known very low or absent levels of an enzyme called DPD, which affects how certain chemotherapy drugs are processed by the body
• People currently taking certain medications that strongly affect the way the body processes drugs (strong inhibitors or inducers of CYP3A, CYP2C8, or UGT1A1 — confirm with trial site)
• People with significant or uncontrolled heart, brain, or other serious health conditions that, in the treating doctor's opinion, would make participation unsafe
• People with a known history of HIV or active tuberculosis (TB) — a positive TB skin test without active disease may still be considered
• People with underlying health conditions that, in the treating doctor's opinion, would make the immunotherapy drug (pembrolizumab) unsafe to administer — for example, lung disease, active infections requiring antibiotics, or recent hospitalisation with unresolved symptoms
• People with known psychiatric conditions or substance use disorders that would interfere with following the study requirements
• People with an active autoimmune disease or a significant history of autoimmune disease that required systemic steroids or immune-suppressing medications — several exceptions apply, including mild or controlled conditions such as asthma managed with occasional inhalers, hypothyroidism stable on hormone replacement, certain skin conditions not requiring systemic treatment, celiac disease controlled by diet alone, or conditions with no active disease in the last 5 years (confirm with trial site for individual circumstances)
• People who are currently using or have used immune-suppressing medications within 14 days before the first dose of pembrolizumab — certain exceptions apply, including steroid nasal sprays, inhalers, skin creams, local injections, low-dose systemic steroids, and steroids used to prevent allergic reactions to scans (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.