Phase 2 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 metastatic pancreatic cancer, confirmed by a tissue or cell sample analysis.
• People whose cancer has been stable (not grown or spread) after receiving at least 8 cycles of a chemotherapy regimen called FOLFIRINOX, based on standard measurement criteria.
• People who are enrolled within 6 weeks of stopping FOLFIRINOX chemotherapy.
• People who have at least one cancer lesion that can be safely sampled for tissue collection.
• People whose blood test shows a specific immune-inflammation score (called SIII) below 900 (confirm with trial site).
• People whose blood level of a cancer marker called CA 19.9 is below 1000 kU/L.
• People aged 18 or older at the time of joining the study.
• People who weigh more than 30 kg.
• People who are generally well enough to carry out daily activities with little or no limitation, based on a standard health performance scale (score of 0 or 1).
• People whose kidneys are functioning adequately, based on a blood test result.
• People whose liver function test results are within acceptable ranges.
• People whose blood counts (white blood cells, platelets, neutrophils, and haemoglobin) are within acceptable ranges.
• People who are willing and able to use effective contraception methods throughout the study and for 90 days after the last dose of the study drug.
• People who are expected to live for at least 12 weeks.
• People who are willing and able to follow the study schedule, including all treatments, clinic visits, and follow-up appointments.
• People who are able to give signed informed consent and agree to the study requirements.

Who may not be able to join:

• People with a certain level of liver disease severity, classified as Child-Pugh grade B or C (confirm with trial site).
• People currently receiving immunotherapy treatments.
• People with a history of another cancer (with some exceptions such as certain small, non-aggressive tumours or non-melanoma skin cancer), unless there has been no sign of that cancer for more than 3 years before the pancreatic cancer diagnosis, or the person's life expectancy from that other cancer is more than 5 years.
• People who have cancer-related fluid build-up in the abdomen or around the lungs.
• People who are pregnant or breastfeeding, or people of reproductive age who are not willing to use effective contraception from the screening period until 90 days after the last study drug dose.
• People with a known allergy or sensitivity to any of the study drugs or their ingredients.
• People with an active autoimmune disease that has required systemic (whole-body) medical treatment in the past 2 years, or a history of certain autoimmune or inflammatory conditions — though several exceptions apply, including vitiligo, hair loss (alopecia), stable thyroid conditions managed with hormone replacement, certain skin conditions not needing systemic treatment, autoimmune conditions with no active disease in the last 5 years (after consultation with the study doctor), and coeliac disease controlled by diet alone.
• People diagnosed with a condition that weakens the immune system, or who have received steroid or immunosuppressive medications within 14 days before the planned first study dose — with some exceptions, such as low-dose, locally applied steroids or steroids used to prevent allergic reactions.
• People who have received a live vaccine within 30 days before the first study dose.
• People who have previously taken part in a clinical trial involving the study drug durvalumab.
• People who have taken part in another clinical trial involving an investigational (experimental) treatment within the last 3 months.
• People currently enrolled in another interventional clinical trial (trials that only observe without giving treatment may be acceptable — confirm with trial site).
• People who received their last cancer treatment less than 28 days before the planned first study dose, or who have not had a long enough break from their previous treatment.
• People who still have significant side effects (grade 2 or higher on a standard scale) from previous cancer treatments, with some exceptions such as hair loss or certain stable lab results. Cases of significant nerve damage or certain irreversible side effects may be considered individually after discussion with the study doctor.
• People currently receiving any other cancer treatment, including chemotherapy, targeted therapy, biological therapy, or hormonal cancer therapy.
• People who have had radiotherapy covering more than 30% of the bone marrow, or wide-field radiotherapy, within 4 weeks of the planned first study dose.
• People who have had major surgery within 28 days before the planned first study dose.
• People who have received an organ transplant from another person.
• People with serious uncontrolled illness, including active infections, heart failure, uncontrolled high blood pressure, unstable heart conditions, certain lung or bowel conditions, or mental health or social circumstances that would make it difficult to safely participate in the study.
• People with a history of cancer spreading to the membranes surrounding the brain and spinal cord.
• People with cancer that has spread to the brain or is pressing on the spinal cord.
• People with a certain type of irregular heart rhythm pattern detected on a heart tracing (ECG), specifically a QTcF measurement of 470 ms or above.
• People with a known active hepatitis infection, or certain positive hepatitis B or C test results at screening — though people with past resolved hepatitis B or C infections may still be eligible under specific conditions (confirm with trial site).
• People known to be HIV-positive or to have an active tuberculosis infection.
• People with serious other health conditions that, in the study doctor's judgement, would put them at risk or prevent them from completing the study.

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