Phase 2 Mesothelioma Trial, Recruiting

Written by an AI model from the 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, of any gender
• People whose general health and ability to carry out daily activities is rated at 0 or 1 on a standard oncology fitness scale (meaning fully active or restricted in strenuous activity only)
• People whose treating doctor estimates they are likely to live for more than 12 weeks
• People who are able to swallow tablets or capsules and are willing to keep a daily record of whether they took the study medication
• Part 1 – Group A: People with a laboratory-confirmed diagnosis of advanced or inoperable mesothelioma (a cancer affecting the lining of the lungs or abdomen) where the treating doctor determines treatment with ipilimumab/nivolumab is appropriate, and who have not had surgery for mesothelioma
• Part 1 – Group B: People with a laboratory-confirmed diagnosis of pancreatic cancer that has spread to other parts of the body (metastatic adenocarcinoma), where the treating doctor determines treatment with nab-paclitaxel and gemcitabine is appropriate
• Part 1 – Group C: People with a laboratory-confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) with a specific gene change called KRAS G12C (confirmed by a validated test), who have already received standard first-line treatment, where the treating doctor determines treatment with sotorasib is appropriate, and who have not previously received a KRAS G12C inhibitor
• Part 2 – Mesothelioma group: People with laboratory-confirmed advanced or inoperable mesothelioma where the treating doctor determines ipilimumab/nivolumab is appropriate, and who have not previously received ipilimumab, nivolumab, or similar checkpoint inhibitor treatments for advanced disease
• Part 2 – Pancreatic cancer group: People with laboratory-confirmed metastatic pancreatic adenocarcinoma where the treating doctor determines nab-paclitaxel and gemcitabine is appropriate, and who have not previously received nab-paclitaxel or gemcitabine for metastatic disease
• Part 2 – Lung cancer group (treatment-naïve): People with laboratory-confirmed locally advanced or metastatic NSCLC with a KRAS G12C mutation (confirmed by validated test), where the treating doctor determines sotorasib is appropriate, and who have not previously received a KRAS G12C inhibitor
• Part 2 – Lung cancer group (previously treated): People with laboratory-confirmed locally advanced or metastatic NSCLC with a KRAS G12C mutation (confirmed by validated test), whose cancer has been documented to have progressed while on a prior KRAS G12C inhibitor (whether approved or investigational)
• Part 2 only: People with measurable tumours that can be assessed using standard imaging criteria (RECIST v1.1, or modified RECIST for mesothelioma)
• People who have a suitable tumour tissue sample available (taken within the past year) from either the original tumour or a metastasis, collected by core needle biopsy, excisional biopsy, or incisional biopsy — bone-only biopsies or decalcified bone samples are not acceptable
• People whose tumour is accessible for two fresh biopsies — one taken before treatment starts and one taken during treatment

Who may not be able to join:

• People who have had another active cancer in the past two years, unless it was a type of skin cancer (basal cell or squamous cell), superficial bladder cancer, or early-stage cervical or breast cancer that has been fully treated
• People who have received chemotherapy, immunotherapy, or other cancer treatments within the two weeks before the trial treatment is due to start
• People who still have unresolved side effects rated moderate or higher (Grade 2 or above on a standard scale) from previous cancer treatments — with some exceptions for certain nerve-related symptoms, hair loss, hormone-related conditions managed with replacement therapy, or symptom-free lab abnormalities
• People who have had major radiation therapy within the four weeks before trial treatment starts, or palliative (symptom-relief) radiation within the two weeks before trial treatment starts
• People with cancer that has spread to the brain or the lining around the brain, unless those areas are not causing symptoms and have already been treated locally (confirm with trial site)
• People who have had a serious active infection within one week before enrolling in the trial
• People with a known positive test result for hepatitis B, hepatitis C, or HIV — testing is not required unless the person shows signs that might suggest one of these infections
• People who have had major surgery within four weeks before the first trial treatment dose, or minor surgery within one week, or who have not yet recovered from surgery-related side effects to below a moderate level
• People who have been taking high doses of steroid or steroid-like medicines (above the equivalent of 10 mg per day of prednisone) within two days before trial treatment starts
• People who are unable to swallow medication, or who have a condition that affects how the gut absorbs medicines (such as uncontrolled nausea, diarrhoea, or vomiting)
• People who have taken another experimental medicine within two weeks (or five half-lives of that medicine, whichever is longer) before trial treatment starts — or within eight weeks if the experimental medicine was a type of antibody-based drug — and who have not completed all required visits for that other trial
• People who have received a live or live-attenuated vaccine (such as those for flu, measles, shingles, yellow fever, or chickenpox) within 28 days before the first trial treatment dose
• People with significant abnormalities in heart rhythm or electrical activity detected on a resting heart tracing (ECG), including specific patterns such as complete left bundle branch block, certain degrees of heart block, a PR interval above 250 ms, or a prolonged QT interval detected on repeated ECG recordings — or people with a personal or family history of risk factors for a specific heart rhythm problem called torsade de pointes, or who are taking medicines known to increase this risk
• People with significant heart problems including severe heart failure (Class III or IV on a standard scale), uncontrolled high blood pressure, unstable chest pain, a heart attack or stroke, reduced heart pumping function (below 50%), or a heart rhythm disorder requiring treatment within the six months before the first trial treatment dose
• People who are pregnant or breastfeeding at the time of screening or at the start of the trial

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