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:

• Adults aged 18 or older.
• People who have finished surgery and all related treatments around the time of their operation, following standard international guidelines.
• People who completed their main cancer treatments (such as surgery, chemotherapy before or after surgery) at least 3 months but no more than 4.5 months before sending samples for testing.
• People who have not received any standard treatment for at least 3 weeks before a blood sample is taken for a specific DNA test.
• People who have not had a blood transfusion for at least 3 months before their blood sample is taken.
• People diagnosed with one of the following cancer types and stages: stage II–III non-small cell lung cancer (NSCLC), stage II–III colorectal cancer, stage I–III pancreatic cancer, or high-grade (grade 3) soft-tissue sarcoma of the limbs or trunk wall.
• People who have enough stored tumour tissue available from their original surgery for the tests required by the trial.
• People who have received a valid result (either positive or negative) from a specific blood-based DNA test before joining the trial.
• People who have never previously received immunotherapy drugs that target PD-1 or PD-L1.
• People who show no signs of cancer remaining on imaging scans, assessed using a standard measurement system called RECIST 1.1.
• People who are generally well enough to carry out all normal daily activities, or who have only minor limitations — assessed using a standard scale called ECOG Performance Status 0 or 1.
• People whose blood test results, taken within 7 days before joining the trial, show that key organs are functioning adequately, including: sufficient levels of blood cells (white cells, platelets, and haemoglobin); normal blood clotting levels; normal liver function; and adequate kidney function. People must not have needed medication to boost blood cell production within 14 days before their sample was collected (confirm with trial site).
• People who have social security coverage in line with French law on biomedical research (as this is a French trial requirement).
• People who understand the trial, are willing to follow all study procedures, and have signed and dated an informed consent form before any trial procedures begin.
• Women who could become pregnant must be willing to use a highly effective form of contraception plus a barrier method (such as a condom) throughout the trial and for at least 120 days after the last dose of the trial drug, and must have a negative pregnancy blood test within 7 days of the first dose.
• Men who have not had a permanent sterilisation procedure must be willing to use a highly effective form of contraception plus a barrier method (such as a condom) throughout the trial and for at least 120 days after the last dose of the trial drug.

Who may not be able to join:

• People who have taken part in another clinical trial using an experimental treatment in the 3 to 4.5 months before this trial, or who would be doing so at the same time as this trial.
• People whose overall health or personal circumstances, in the judgement of the treating doctor, make taking part in a clinical trial unsuitable or unlikely to be safe.
• People who are pregnant or breastfeeding.
• People who are under legal guardianship, have had their freedom restricted by a legal or administrative decision, or are unable to give their own consent.
• People with non-small cell lung cancer who have specific genetic changes in their tumour (EGFR exon 19 deletions or exon 21 L858R substitutions), because a different standard treatment already exists for those genetic profiles.
• People who have received medicines designed to stimulate the immune system (such as interferons or interleukin-2) within 4 weeks (or five half-lives of the drug, whichever is shorter) before joining the trial.
• People who have taken medicines that suppress the immune system (such as corticosteroids, cyclophosphamide, azathioprine, methotrexate, or thalidomide) within 2 weeks before starting the trial treatment, or who are expected to need these medicines during the trial — though some exceptions apply for short-term or low-dose use (confirm with trial site).
• People who experienced a severe (grade 3 or higher) immune-related side effect from a previous immunotherapy treatment, or who still have unresolved immune-related side effects above a mild level.
• People who are known to be intolerant or allergic to the trial drugs or their ingredients.
• People who have previously had a stem cell transplant from a donor or a solid organ transplant (such as a kidney or liver transplant).
• People who have received a live or weakened vaccine within 4 weeks before joining the trial, or who are expected to need one during the trial or within 5 months after the last dose of trial drugs — COVID-19 vaccines are an exception to this rule.
• People with an active autoimmune disease or a condition causing a weakened immune system — with the exception of treated underactive thyroid caused by autoimmune disease, or type 1 diabetes managed with insulin.
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, drug-caused lung inflammation, or organising pneumonia — or who currently show signs of active lung inflammation (a history of radiation-related lung scarring is generally acceptable, confirm with trial site).
• People who have had major surgery within 56 days before joining the trial, or whose surgical wound has not fully healed.
• People with a history of HIV infection.
• People with an active hepatitis B or hepatitis C infection — though people with past or resolved hepatitis B, or hepatitis C with a negative RNA test result, may be eligible (confirm with trial site).
• People with active tuberculosis.
• People who have had a severe allergic or anaphylactic reaction to similar types of antibody-based medicines in the past.
• People who have had a serious infection requiring hospital admission within 4 weeks before starting treatment.
• People who have taken antibiotic medicines by mouth or through a drip for a serious infection within 2 weeks before starting treatment.
• People with significant heart conditions, including a heart attack, acute coronary event, or coronary procedure (such as stenting or bypass surgery) within the past 6 months, or moderate-to-severe heart failure — unless recent heart function testing shows the heart is pumping adequately (confirm with trial site).
• People with uncontrolled high blood pressure (systolic above 150 and/or diastolic above 110 mmHg), unless blood pressure medication brings it down to acceptable levels.
• People who have had a stroke or mini-stroke (transient ischaemic attack) within 6 months before joining the trial.

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