Phase 1 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 pancreatic cancer (a specific type called adenocarcinoma), confirmed through laboratory testing of a tissue sample.
• People whose tumour has one of seven specific gene changes (mutations) in a gene called KRAS: G12D, G12V, G12R, G12C, G12A, G12S, or G13D.
• People whose cancer is considered removable by surgery, or on the border of being removable, and has not spread to other parts of the body (confirmed by a recent CT or MRI scan).
• People who have received up to 4 doses of a chemotherapy regimen called mFOLFIRINOX before joining, provided any side effects have largely resolved.
• People aged 18 or older.
• People who are in reasonably good general health, able to carry out light activity and care for themselves (assessed by a standard medical scale called ECOG, rated 0 or 1).
• People who are not pregnant or breastfeeding, with pregnancy confirmed by a test taken within 28 days before treatment starts.
• People whose blood counts, kidney, liver, and heart function meet minimum levels set by the trial (the trial site will check these through blood and urine tests).
• People whose treating doctor estimates they have a life expectancy of at least 12 weeks.
• People who are willing and able to attend appointments and follow the trial's procedures.
• People who do not have an active infection needing intravenous antibiotics.
• People with a history of another cancer may still be considered eligible, as long as that cancer or its treatment is not expected to interfere with this trial (confirm with trial site).
• People of reproductive age who are willing to use highly effective contraception from the screening period until 90 days after the last dose of immunotherapy.

Who may not be able to join:

• People whose pancreatic cancer has grown in a way that makes surgery impossible due to involvement of major blood vessels or spread into the main body artery (aorta), as defined by standard medical guidelines.
• People whose cancer has spread (metastasised) to other parts of the body.
• People who have previously received certain types of immunotherapy treatments, including checkpoint inhibitors (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 drugs) or certain immune-stimulating drugs targeting proteins called OX40, CD27, CD137/4-1BB, or GITR.
• People with an active infection, including tuberculosis, hepatitis A, active hepatitis B, or active hepatitis C (people with resolved or previously treated hepatitis B or C may still be considered — confirm with trial site).
• People with a known HIV infection that does not meet the trial's specific health criteria (confirm with trial site).
• People with active or previously documented autoimmune or inflammatory conditions such as inflammatory bowel disease, lupus, rheumatoid arthritis, multiple sclerosis, myasthenia gravis, or similar conditions. Some milder or well-controlled conditions such as vitiligo, stable thyroid conditions on medication, or diet-controlled coeliac disease may be exceptions (confirm with trial site).
• People with serious uncontrolled health conditions such as heart failure, unstable chest pain, uncontrolled irregular heartbeat, uncontrolled high blood pressure, lung inflammation (interstitial lung disease), severe ongoing diarrhoea, or significant mental health or social circumstances that would make trial participation difficult.
• People who have taken immune-suppressing medications within 14 days before the first dose of the trial drug (some exceptions apply, such as low-dose steroids or inhaled/topical steroids — confirm with trial site).
• People who have received a live vaccine within 30 days before the first dose of immunotherapy.
• People who are pregnant, breastfeeding, or unwilling to use effective contraception during treatment and for 90 days after the last immunotherapy dose.
• People with a known allergy or sensitivity to the trial drugs or their ingredients.
• People diagnosed with another cancer within the past 3 years, with some exceptions such as certain treated skin cancers, early-stage bladder cancer, localised prostate cancer, or cervical carcinoma in situ (confirm with trial site).
• People who have previously received an organ transplant from another person (allogeneic transplant).

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