Phase 2 Melanoma 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 aged 18 or older at the time of signing the consent form.
• People diagnosed with certain advanced or spreading solid tumours that cannot be surgically removed — specifically, hormone receptor-positive (ER+), HER2-negative breast cancer (Group 1) or melanoma (Group 2), confirmed by laboratory testing of tumour tissue or cells.
• Breast cancer patients whose cancer has specific gene changes (in PIK3CA, AKT1, or PTEN) and whose disease has progressed after at least two hormone-based treatments, or whose cancer came back during or within 12 months of completing earlier treatment — and who are candidates to start a medicine called capivasertib as determined by their treating doctor.
• Premenopausal people with ER+ HER2- breast cancer who are receiving, or will receive, ovarian suppression treatment (such as an LHRH agonist) as part of their standard care.
• Melanoma patients whose cancer has progressed or who could not tolerate prior immune checkpoint inhibitor therapy.
• Melanoma patients with a BRAF gene mutation whose cancer has also progressed on, or who could not tolerate, an approved BRAF or MEK inhibitor treatment.
• Melanoma patients whose immune checkpoint inhibitor side effects have resolved to a mild level (Grade 0–1) and who have been on low-dose or no steroid treatment for at least 2 weeks.
• People whose cancer can be measured or assessed using standard imaging criteria (RECIST 1.1) at the time of joining.
• People with brain metastases that were previously treated and are now stable — meaning no signs of growth for at least 4 weeks on repeat scans, no symptoms, and no need for steroid treatment for at least 14 days before starting the study drug.
• People willing to have a fresh tumour biopsy taken during the study if it is safe and practical to do so (a stored tissue sample from within the past year may also be acceptable; lack of a biopsy alone will not necessarily prevent someone from joining).
• People with a general health and activity level rated as 0 or 1 on the ECOG scale — meaning fully active or able to carry out light activity (confirm with trial site).
• People with a life expectancy of at least 12 weeks.
• People whose blood counts and organ function (liver, kidneys, blood clotting, thyroid) meet the specific laboratory levels required by the trial.
• People who have recovered from the side effects of prior cancer treatments, with enough time having passed since the last treatment (the required gap varies depending on the type of treatment received).
• People with a previous or low-risk second cancer, such as certain skin cancers, early-stage cancers in remission for 2 or more years, low-risk prostate cancer, or any cancer from which the person has been disease-free for 3 or more years.
• People who are able to take medicines by mouth.
• People who are willing and able to attend follow-up appointments as required.
• Both male and female patients who are willing to use highly effective contraception before, during, and for at least 3 months after treatment.

Who may not be able to join:

• Melanoma patients who have received radiation therapy or biological cancer therapy within 4 weeks before the first dose, or who have not yet recovered from side effects of such treatments.
• Melanoma patients who are expected to need other systemic or local cancer treatments while on the study.
• Melanoma patients who have used systemic steroid therapy within 2 weeks before starting the study treatment, or who are on any other immunosuppressive medication.
• People who cannot tolerate any component of the study drug combinations or standard care therapies.
• People with significant active neurological conditions such as epilepsy, stroke, severe brain injury, dementia, Parkinson's disease, psychosis, or active spreading of cancer to the lining of the brain (unless previously treated brain metastases are stable, as described above).
• People with active inflammatory nerve disorders such as Guillain-Barré Syndrome, ALS (motor neurone disease), or multiple sclerosis.
• People who have had radiation therapy, surgery, chemotherapy, or immunotherapy within 4 weeks before joining (or 6 weeks for certain specific chemotherapy drugs); prior use of the chemotherapy drug Adriamycin is not permitted at all.
• People who have received targeted small molecule therapy within 7 days, or chemotherapy within 14 days, before starting the trial treatment.
• People with an active autoimmune disease (such as lupus, rheumatoid arthritis, or Sjögren's syndrome) that has required systemic treatment in the past 2 years (hormone or gland replacement therapy is not counted as systemic treatment for this purpose).
• People with significant heart or cardiovascular conditions, including poorly controlled high blood pressure, history of heart attack, unstable angina, coronary artery disease, stroke, heart failure, certain abnormal heart rhythms, pacemakers or implantable defibrillators, or abnormal heart function measurements.
• People with certain abnormal heart electrical readings (ECG), including a prolonged QTc interval (above 450ms), certain types of heart block, or significant rhythm abnormalities.
• People who have had major (non-diagnostic) surgery within 4 weeks before Day 1 of the trial.
• People with active bacterial, viral, or fungal infections that require systemic treatment.
• People who are pregnant or breastfeeding; women of childbearing potential must have a negative pregnancy blood test within 1 week before treatment.
• People with unresolved side effects above a mild level (Grade 1) from previous cancer treatment, except for stable long-term effects not expected to improve (such as certain nerve symptoms or hair loss).
• People who are unwilling or unable to follow the study procedures.
• People with active liver disease, or currently active hepatitis A, B, or C infection (people with successfully treated hepatitis C with undetectable virus, or prior hepatitis B with negative PCR test, may still be considered eligible — confirm with trial site).
• People with a serious non-cancer illness that the treating doctor or trial sponsor considers would interfere with the study.
• People currently taking part in another clinical trial, or who have received an experimental treatment within the last 28 days (with one specific study exception — confirm with trial site).
• People with digestive conditions or prior gut surgeries that could affect how the study drug is absorbed, or who are unable to swallow capsules or tablets whole.
• People who have had a significant allergic reaction or intolerance to any of the study drugs or similar compounds (including AMXT 1501, DFMO, or standard of care therapies used in this study).
• Breast cancer patients (Group 1) using other hormonal therapies during the study (except ovarian suppression treatment for premenopausal patients, which is permitted).
• People taking biotin (Vitamin B7) supplements at doses higher than 30 micrograms per day (those who reduce their dose to 30 micrograms or less per day may be eligible — confirm with trial site).
• People with uncontrolled, severe, or life-threatening infections (people on preventive antibiotic, antifungal, or antiviral medication with no active infection may still be eligible; people with well-controlled HIV may also be eligible — confirm with trial site).
• People with an active or past history of autoimmune disease, with some exceptions (such as stable, well-controlled type 1 diabetes, vitiligo, stable thyroid conditions, or autoimmune hair loss, provided these do not require immunosuppressive treatment).
• People with another cancer that is actively progressing or requires treatment, with certain exceptions for specific skin cancers or treated cervical cancer.
• For the group receiving pembrolizumab in combination: people with a severe (Grade 3 or higher) allergic reaction to pembrolizumab; people who have received high-dose lung radiation within the past 6 months; people with a history of or current serious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment; people with a history of radiation-related lung inflammation; people who have had an organ transplant or bone marrow transplant from a donor.

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