Phase 1 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 who are 18 years of age or older.
• People who are willing and able to give their informed consent to participate.
• People who have been confirmed by tissue testing to have advanced melanoma or triple-negative breast cancer (TNBC) that cannot be surgically removed, has spread to other parts of the body, and has continued to grow despite standard treatments, or where no standard treatment is available or was declined.
• During the dose-finding phase, people with melanoma or TNBC meeting the above criteria, including those who may have cancer that has spread to the brain.
• During the dose-expansion phase, the following specific groups may be considered: melanoma patients without brain spread who have stopped responding to certain immunotherapy treatments (anti-PD-1 or anti-PD-L1); melanoma patients with active, untreated brain spread who have stopped responding to those same immunotherapy treatments; and TNBC patients with active, untreated brain spread (prior immunotherapy is not required for this group).
• People who have had a brain MRI scan within the past 28 days to confirm their eligibility for the relevant group in the trial.
• People whose cancer can be measured on scans according to standard medical criteria (RECIST v1.1).
• People whose heart, liver, kidneys, and other organs are functioning adequately as defined by the trial's testing requirements.
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work).
• People who are expected to live for at least 12 weeks.
• People who are able to swallow and keep down tablets or capsules taken by mouth.
• During the dose-expansion phase, people with certain cancer types who are willing to provide a fresh tissue sample (biopsy) before treatment and at least once during treatment, if it is safely accessible (biopsies are optional during the dose-finding phase).
• Women who could become pregnant must have a negative pregnancy test within 72 hours before the first dose of study treatment.
• Women who could become pregnant must agree to use effective contraception from the time of screening until 4 months after the last dose of study treatment (this does not apply to women who are post-menopausal, have had a hysterectomy or both ovaries removed, have documented ovarian failure, or have had surgical sterilisation).
• Male participants whose partners could become pregnant must agree to use effective contraception from the time of screening until 4 months after the last dose of study treatment.

Who may not be able to join:

• People with a history of, or currently active, autoimmune diseases such as inflammatory bowel disease, rheumatoid arthritis, lupus, scleroderma, autoimmune vasculitis, nerve conditions like Guillain-Barré syndrome or myasthenia gravis, or autoimmune thyroid disease — though people whose thyroid condition is stable and well-managed with medication may still be considered (confirm with trial site).
• People with an active infection or who have had a serious medical event such as a stroke in the past 6 months.
• People still experiencing side effects from previous cancer treatment that are rated above a mild level (Grade 1), except for hair loss or mild anaemia with haemoglobin above a certain level.
• People who have received chemotherapy or radiation therapy within 2 weeks before starting the study treatment (or within 6 weeks for certain specific chemotherapy drugs).
• People with significant stomach or bowel problems that could affect how the body absorbs oral medication, such as severe ulcers, uncontrolled nausea, vomiting, diarrhoea, or a history of major bowel surgery.
• People who have had major surgery within 14 days before joining the trial.
• People with severe or poorly controlled disease affecting the lungs, liver, kidneys, or heart.
• People with Type 1 diabetes, or Type 2 diabetes that is not well controlled.
• People with a history of acute pancreatitis (sudden inflammation of the pancreas) within the past year, or a history of chronic pancreatitis.
• People who have had a severe skin reaction to a medication in the past, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, or DRESS syndrome.
• People whose heart's electrical activity (measured by ECG) shows a specific abnormality above set thresholds, or who have a history of a heart condition called long QT syndrome.
• People with a history of heart attack, unstable chest pain, or heart procedures such as stenting or bypass surgery within the past 6 months; those with severe heart failure (Class III or IV); those with known reduced heart pumping function; or those with cancer that has spread to the heart.
• People with poorly controlled high blood pressure (systolic at or above 150 mmHg or diastolic above 100 mmHg), though adjusting blood pressure medication 30 or more days before joining may be considered (confirm with trial site).
• During the dose-expansion phase for groups with active brain metastases: people who have any single untreated brain tumour larger than 3.0 cm, or a brain lesion in a location that poses immediate risk and requires urgent local treatment; people using steroid medication to manage brain tumour symptoms at a dose above a certain daily level; or people with poorly controlled seizures or worsening neurological symptoms from brain metastases.
• People who have had lung inflammation (pneumonitis) in the past that required steroid treatment, or who currently have pneumonitis.
• People with any medical condition, ongoing therapy, or lab result that the treating doctor believes could interfere with the trial results or would not be in the person's best interest.
• People with a known psychiatric condition or substance use problem that the treating doctor believes would prevent them from following the trial requirements.
• People with a known history of hepatitis B, hepatitis C, or a positive HIV test.
• People who have received a live vaccine within 30 days before the planned start of treatment (standard flu injections and COVID-19 vaccines are generally allowed; nasal spray flu vaccines are not).
• People currently taking, or expected to need during the study, any medications listed as prohibited by the trial.
• People with a known allergy to drugs that are chemically or biologically similar to the two study drugs (alpelisib and pembrolizumab).
• People who are pregnant or currently breastfeeding.

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