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 advanced pancreatic cancer (a specific type called adenocarcinoma) that has been confirmed by a lab test, and whose cancer is considered either "borderline resectable" (possibly removable by surgery) or "locally advanced" (not able to be removed by surgery) based on standard medical guidelines.
• People whose cancer has spread to nearby lymph nodes, as long as those lymph nodes are close to the main tumor, as assessed by a radiation specialist.
• People who have already received at least 2 months of chemotherapy (such as FOLFOX, FOLFIRINOX, gemcitabine, or similar treatments) for this cancer without the cancer getting worse locally or elsewhere in the body. People newly diagnosed with this cancer may be screened early but must complete 2 months of chemotherapy before joining. The last chemotherapy dose must have been at least 2 weeks before entering the trial.
• People aged 18 or older.
• People who are generally able to carry out everyday activities with little to no limitation (based on a standard doctor-assessed scale called ECOG, with a score of 0 or 1).
• People whose doctors estimate they have a life expectancy of more than 3 months.
• People whose blood, liver, and kidney test results meet certain minimum levels, including healthy enough counts of blood cells, liver enzymes, kidney function markers, and other indicators — specific thresholds will be checked by the trial team.
• People whose heart is pumping well enough, as shown by a heart scan (echocardiogram or MUGA scan) with a pumping efficiency of at least 55%.
• People whose heart's electrical activity (measured by a test called an ECG) shows a specific timing measurement (QTc) below 480 milliseconds.
• People who are willing and able to use highly effective contraception (such as hormonal methods, barrier methods, or abstinence) throughout the trial and for a set period after treatment ends. Women who could become pregnant must have a negative pregnancy test within 14 days before joining. Men must use contraception during the trial and for 90 days after finishing treatment.
• People who are able to understand the trial and are willing to sign a consent form. A legal representative may sign on behalf of someone who cannot do so themselves.

Who may not be able to join:

• People with a history of another cancer, unless that cancer is very unlikely to interfere with the safety or effectiveness of this trial (as decided by the treating doctor).
• People who have a noticeable build-up of fluid in the abdomen or around the lungs that requires a procedure to drain it.
• People who have previously been treated with certain types of targeted cancer drugs, including FAK inhibitors, RAF/MEK inhibitors, or specific immune checkpoint therapies (such as drugs targeting PD-1, PD-L1, PD-L2, CD137, or CTLA-4).
• People who have previously had an immune reaction to human-derived antibody treatments (confirm with trial site).
• People who are currently taking part in another clinical trial, or who have taken an experimental treatment within 4 weeks (or within 5 half-lives of the drug, whichever is shorter) before joining.
• People with a known history of allergic reactions to the trial drugs (defactinib or avutometinib) or to similar types of compounds, or to certain inactive ingredients found in the trial medications (including hydroxypropylmethylcellulose, mannitol, or magnesium stearate).
• People with a diagnosed immune deficiency condition, or who are currently taking long-term steroid medications or other drugs that suppress the immune system (beyond what might be part of a standard chemotherapy regimen).
• People who must continue taking warfarin (a blood thinner) and cannot safely switch to a different blood-thinning medication.
• People who have an active autoimmune disease (where the immune system attacks the body) that has required treatment with immune-modifying drugs, steroids, or other immune-suppressing medicines within the past 2 years. Routine hormone replacement therapies (such as thyroid hormone or insulin) are not considered a reason to exclude someone.
• People who have received a live vaccine within 30 days before joining the trial. Live vaccines include measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, and the live nasal flu spray (such as FluMist). Standard injected flu vaccines are generally acceptable.
• People with a known active or past infection with hepatitis B or hepatitis C virus.
• People who have a history of lung inflammation (pneumonitis) not caused by infection that required steroid treatment, or who currently have pneumonitis.
• People with a known history of active tuberculosis (TB).
• People who have had major surgery within 28 days before joining the trial.
• People who are pregnant or breastfeeding.
• People living with HIV whose immune cell count (CD4+) is below 350 cells per microlitre, or who have had a serious HIV-related infection in the 12 months before joining. People with HIV who have well-controlled disease on appropriate treatment may still be considered eligible.
• People who have had a confirmed COVID-19 (SARS-CoV-2) infection within 10 days before joining.
• People who have recently taken certain medications, supplements, herbal remedies, or foods that are known to interact with the trial drugs within a specific timeframe before joining. This includes substances that strongly affect certain liver enzymes (CYP3A4, CYP2C9) or drug transport proteins (P-gp, BCRP) — the trial site can advise on specific substances.
• People who cannot swallow tablets or capsules, or who have difficulty absorbing medicines through the gut due to previous stomach removal surgery or active inflammatory bowel disease.
• People with an active skin condition that has required systemic (whole-body) treatment within the past year and could make it difficult to assess the trial treatment's side effects.
• People with a significant history of a muscle breakdown condition called rhabdomyolysis.
• People with certain eye conditions, including glaucoma, a history of retinal vein blockage, uncontrolled high blood pressure or diabetes that could affect the eyes, certain types of retinal disease, elevated eye pressure (above 21 mmHg), or active serious corneal (front-of-eye) disorders that would prevent proper monitoring during the trial. Minor conditions such as dry eyes or uncomplicated corneal erosions are not excluded.
• People with serious heart conditions, including current heart failure, a history of severe heart disease (Class III or IV), a heart attack within the last 6 months, unstable heart rhythm problems, unstable chest pain (angina), or severe lung disease.
• People with any other significant medical condition (such as serious heart, digestive, lung, psychiatric, neurological, or substance-related conditions) identified within the 3 months before joining that, in the doctor's opinion, would put the person at unacceptably high risk.
• People with an active, uncontrolled infection (bacterial, viral, or fungal) that has not improved with appropriate treatment, or who still have a fever within 48 hours of stopping infection treatment.
• People who are not willing to follow the lifestyle guidance outlined in the trial protocol (confirm with trial site for details).

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