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:

• Adults aged 18 years or older who weigh more than 30 kg (about 66 pounds)
• People with an expected survival of at least 12 weeks
• People who have been diagnosed with advanced pancreatic cancer, liver cancer (hepatocellular carcinoma), or bile duct/gallbladder cancer (biliary tract cancer) that cannot be cured by local treatment or surgery — with only one cancer type present, not a mix
• For liver cancer (HCC): people whose diagnosis was confirmed by tissue sample, or — if a biopsy is not possible — by recognised clinical criteria in people with liver cirrhosis (confirm with trial site)
• People who have finished radiation therapy at least 4 weeks before starting the trial and whose side effects from that treatment have mostly resolved
• People who are able to give their own informed consent to join
• People with a general health and activity level rated as ECOG 0, 1, or 2 (meaning able to carry out at least some daily activities, ranging from fully active to limited in strenuous activity but able to be up and about) (confirm with trial site)
• People whose cancer can be measured on scans according to standard criteria (RECIST v1.1)
• Women who could become pregnant must have a negative pregnancy test at screening
• People of reproductive age (men and women) who are willing to use highly effective contraception during the trial and for 6 months after the last dose of study medication
• Women who are breastfeeding must stop nursing before starting treatment and for 90 days after the last dose if on the single-drug treatment, or 180 days after the last dose if on the two-drug combination
• Male participants must agree not to donate sperm during the trial and for at least 6 months after the last dose
• People who are able to follow the study schedule and requirements
• People whose blood test results meet the required levels for blood cell counts, kidney function, and liver function as assessed by the trial site

Who may not be able to join:

• People who have already received systemic (whole-body) treatment such as chemotherapy for their advanced cancer
• People who have had lung inflammation (pneumonitis) in the past that required treatment with steroids
• People with a history of active scarring or inflammation of the lung tissue (interstitial lung disease)
• People with liver cancer (HCC) whose liver function is rated below a certain level (Child-Pugh B or C) — the trial requires Child-Pugh A status (confirm with trial site)
• People with serious heart or blood vessel problems in the past 6 months, such as stroke, heart attack, unstable chest pain, significant heart failure, or serious irregular heartbeat requiring medication
• People with uncontrolled ongoing illnesses, including active infections, uncontrolled high blood pressure, severe digestive conditions causing diarrhoea, or mental health/social circumstances that would make it difficult to follow the study requirements
• People with a heart rhythm measurement (QTcF) at or above 470 ms on an ECG — particularly relevant if receiving a study drug that may affect heart rhythm (confirm with trial site)
• People with a history of another cancer, unless they have been cancer-free for 3 years, have had completely removed non-melanoma skin cancer, successfully treated early-stage cervical cancer, or a removed cancer that did not need systemic treatment after surgery
• People with active cancer spread to the brain or the lining of the brain — though people with previously treated and stable brain metastases, who are off steroids and anti-seizure medications and have had 6 weeks of stable imaging, may be considered
• People currently taking immune-suppressing medications, with some exceptions such as low-dose topical/inhaled steroids, low-dose systemic steroids (up to 10 mg/day prednisone or equivalent), or steroids used to prevent allergic reactions before scans
• People who have had an organ transplant or bone marrow/stem cell transplant
• People with active autoimmune diseases that could worsen with immune-stimulating treatment — though people with Type 1 diabetes, vitiligo, psoriasis, or thyroid conditions not requiring immune-suppressing treatment may be considered
• People with active infections requiring treatment, including tuberculosis, active hepatitis B or C, or HIV — some people with past (resolved) hepatitis B or hepatitis C infection may be considered depending on specific test results (confirm with trial site)
• People with a known history of severe allergic reactions to the study drugs or similar antibody-based medicines
• People with other serious medical or psychiatric conditions — including inflammatory bowel disease, lung scarring, or suicidal thoughts or behaviour in the past year — that the treating doctor believes would make participation unsafe
• People with ongoing significant side effects from previous treatments (above a certain severity level), with some exceptions such as mild nerve sensitivity or hair loss
• People already enrolled in another clinical trial involving an experimental treatment that could interfere with this study
• Pregnant people or those of reproductive potential not willing to use effective contraception for the required period after treatment
• People who have had a major surgical procedure within 28 days before starting the trial (minor local surgery for symptom relief may be acceptable — confirm with trial site)
• People who have received a live vaccine within 30 days before starting the trial, and participants must not receive live vaccines while on the study or for 30 days after the last dose
• People who have previously participated in a clinical trial involving durvalumab or tremelimumab (the study drugs), regardless of which treatment group they were in
• People with asthma requiring steroid inhalers who have been admitted to hospital for an asthma attack within the past year

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