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
• People with a life expectancy of at least three months
• People who have been diagnosed (confirmed by laboratory testing of tissue or cells) with unresectable or metastatic stage III or IV acral melanoma (a type of melanoma found on palms, soles, or under nails) that has continued to grow or spread despite standard treatments
• People who are able to provide a stored tumour tissue sample or a previous biomarker test report; if no stored sample is available, a fresh tissue biopsy taken by needle or core needle method may be accepted (confirm with trial site)
• People who are reasonably physically active and able to carry out light daily activities, with minimal or no restriction due to illness (a score of 0 or 1 on a standard medical scale)
• People who have at least one tumour that can be measured using standard imaging guidelines
• People whose blood counts, kidney function, liver function, blood clotting, and protein levels fall within the ranges required by the trial (confirm specific values with trial site)
• People who are willing and able to sign a written consent form
• People of childbearing potential who are willing to use effective contraception during the trial and for 90 days after the last treatment; women of childbearing age must have a negative blood pregnancy test within 7 days before starting treatment

Who may not be able to join:

• People who have received anti-cancer treatments such as chemotherapy, radiation, immunotherapy, or similar therapies within the past 4 weeks
• People who have taken certain oral anti-cancer tablets or targeted therapy drugs within the past 2 weeks, or within 5 half-lives of the drug (whichever is longer)
• People who have used traditional Chinese herbal medicines with anti-cancer properties within the past 2 weeks
• People who have taken part in another clinical trial using an unapproved drug within the past 4 weeks
• People who have had major surgery or a serious injury within the past 4 weeks (routine tumour biopsies are generally excluded from this, but invasive dental procedures such as tooth extractions or implants are included)
• People with current or previous severe eye disease affecting the retina, if considered unsuitable by the study doctor
• People with significant heart or blood vessel problems, including serious irregular heartbeat, a prolonged electrical signal in the heart (QTc interval above certain limits), major heart or vascular events in the past 6 months (such as heart attack, stroke, or blood clots), moderate to severe heart failure, weak heart pumping function, or high blood pressure that cannot be controlled with medication
• People with active cancer spread to the lining of the brain or spinal cord, or brain metastases that are not well controlled (people with treated and stable brain metastases that have shown no change on scans for at least 12 weeks before screening may still be considered — confirm with trial site)
• People with lung inflammation (interstitial lung disease or radiation pneumonia) that requires steroid treatment
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that has needed draining or medical treatment within the past 7 days
• People who have had another cancer in the past 5 years (certain cured skin, breast, cervical, or bladder cancers may be exceptions — confirm with trial site)
• People who have had a serious bleeding episode (grade 3 or above) within the past 6 months, or who currently have ongoing bleeding, abnormal blood vessels, or conditions that carry a high risk of bleeding (such as active stomach ulcers or swollen veins in the oesophagus)
• People who have taken certain medications within the past 2 weeks that strongly affect how the body processes a specific liver enzyme pathway (CYP3A4) — confirm specific medications with trial site
• People who still have significant side effects (grade 2 or above) from previous cancer treatments, with some exceptions such as mild nerve problems or hair loss
• People with active hepatitis B where the virus level is not within acceptable limits, or active hepatitis C
• People who test positive for HIV or syphilis antibodies
• People with active bacterial, viral, or fungal infections requiring systemic antibiotic or antiviral treatment
• People who are pregnant or breastfeeding
• People with significant mental health or neurological conditions that may make it difficult to follow the trial requirements
• People with conditions, substance use, or dependence that could affect how side effects are assessed or make participation unsafe
• People who are unable to swallow tablets or who have conditions affecting the absorption of oral medications, such as a blockage in the bowel
• People with significant liver disease including severe scarring of the liver, liver shrinkage, high blood pressure in the liver's blood vessels, or moderate to severe fluid in the abdomen
• People who have previously had an organ transplant
• People with other serious medical conditions considered unsuitable for the trial by the study doctor
• People who have received a live vaccine within the past 28 days (standard inactivated flu vaccines and inactivated COVID-19 vaccines are generally permitted; live nasal flu vaccines and COVID-19 mRNA vaccines are not)

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