Phase 3 Pancreatic Cancer Trial, Recruiting

Written by an AI model from 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 have been diagnosed with a specific type of pancreatic cancer called ductal adenocarcinoma, confirmed by laboratory testing of tumor tissue.
• People whose tumor testing (done through a certified laboratory using a tissue sample — not a blood test) has shown the absence of certain gene changes called KRAS mutations and a specific BRAF mutation (BRAF V600E).
• People whose cancer cannot be surgically removed and/or has spread to other parts of the body, confirmed by a CT scan or MRI taken within a specific timeframe before joining the trial.
• People whose tumor testing has not found certain other gene changes, including mutations in PTEN, NRAS, or EGFR, nor amplifications of HER2 or MET, nor specific gene fusions (confirm with trial site if not all of these were tested).
• People who have received exactly one prior course of chemotherapy for their locally advanced or metastatic pancreatic cancer, and whose cancer has since grown, stopped responding, or who were unable to tolerate that treatment.
• People who have previously received certain additional targeted therapies (for specific molecular features of their cancer, such as MSI-high or certain gene fusions) may still be eligible — the treating doctor would assess this.
• People who previously received maintenance therapy with Olaparib or Rucaparib (for certain inherited or tumor-based gene mutations) — this does not count as a prior line of chemotherapy for eligibility purposes.
• People aged 18 or older at the time of joining the trial.
• People who are well enough to carry out daily activities, assessed using a standard scale called the Zubrod performance status, with a score of 0, 1, or 2.
• People whose recent blood test results (taken within 28 days before joining) show their blood cell counts and organ function are within the required ranges, including white blood cells, red blood cells, platelets, liver function markers, and kidney function.
• People living with HIV, provided they are on effective treatment and their most recent viral load test (within 6 months) shows the virus is undetectable.
• People with a history of chronic hepatitis B, provided their viral load is undetectable on suppressive therapy (if required), based on testing within 6 months.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable viral load on recent testing (within 6 months).
• People who have read and signed an informed consent form agreeing to take part in the study (a legally authorised representative may sign on behalf of someone who is unable to do so themselves).
• People who are willing to provide tissue or blood samples for research banking (this will be offered as an opportunity).
• People who speak English or Spanish and are willing to complete quality-of-life questionnaires (this will be offered as an opportunity).

Who may not be able to join:

• People whose cancer has spread to the brain or the area around the brain, unless that spread was treated with radiation and/or surgery and has been stable for at least 28 days, and the person has no neurological symptoms and is not taking steroid medications at the time of joining.
• People who have previously been treated with a type of cancer drug that targets the EGFR protein using an antibody (such as cetuximab or panitumumab).
• People who have previously been treated with a type of drug called an EGFR tyrosine kinase inhibitor (such as erlotinib).
• People who have received any pancreatic cancer treatment — including standard chemotherapy, investigational therapy, targeted therapy, or radiation — within 14 days before joining the trial.
• People who have a medical reason why they cannot safely receive the chemotherapy planned for this trial, based on approved prescribing guidelines.
• People who have another current or past cancer that, in the treating doctor's opinion, could interfere with assessing the safety or effectiveness of the trial treatment.
• People who are pregnant or breastfeeding (including milk expressed by any means).
• People of reproductive potential who have not agreed to use effective contraception during the trial.

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