Phase 2 Melanoma 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:

• You are between 18 and 75 years old.
• You have been diagnosed with acral melanoma (a type of melanoma found on palms, soles, or under nails) at stage III or IV that can be surgically removed, and you have at least one measurable area of disease that has not already been treated locally.
• You have not received any anti-cancer treatment before for this condition.
• You are generally active and able to carry out daily activities with little or no limitation (confirm with trial site regarding exact fitness level required).
• You are able to provide a tissue sample from your tumour for genetic testing.
• Your expected survival is at least 12 weeks.
• Your blood, liver, kidney, and heart are functioning at an acceptable level, based on tests taken within 7 days before joining the trial (confirm with trial site for exact values).
• If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days before starting treatment.
• If you or your partner could become pregnant, you must agree to use effective contraception throughout the study and for 3 months after treatment ends.
• You are able to swallow pills normally.
• You are willing to take part voluntarily, sign a consent form, and attend follow-up appointments.

Who may not be able to join:

• You have previously been treated with certain types of immunotherapy or targeted therapy drugs (anti-PD-1, anti-PD-L1, or VEGFR TKI treatments).
• You are currently taking part in, or have taken part in, another clinical drug trial within the past 4 weeks.
• You have had major surgery, a vaccine, or systemic steroid treatment in the past 4 weeks, or radiation therapy in the past 2 weeks.
• You have had another type of cancer in the past 3 years, other than certain fully treated skin or early-stage cancers (confirm with trial site for specifics).
• You have received certain blood-stimulating injections (such as G-CSF or erythropoietin) within 1 week before starting the trial.
• You have tested positive for HIV.
• You have active hepatitis B or C (confirm with trial site for specific test results that apply).
• You have significant amounts of protein in your urine, confirmed by testing.
• You have high blood pressure that cannot be controlled with medication (readings at or above 140/90 mmHg).
• You have fluid build-up around your lungs or abdomen that is causing symptoms.
• You have melanoma that has spread to your eyes or brain.
• You have a history of active tuberculosis.
• You have an autoimmune disease, or have previously needed steroids or immune-suppressing drugs to treat such a condition.
• You have had a serious heart or blood vessel event (such as a blood clot, heart attack, stroke, or related procedure) within the past 6 months.
• You have serious uncontrolled health conditions such as uncontrolled diabetes, severe heart failure, unstable heart rhythm, recent stroke, or lung disease such as interstitial pneumonia.
• You have any condition that prevents you from swallowing pills or absorbing medication properly, including previous removal of part of the digestive system.
• You have previously had a stem cell or organ transplant.
• You are pregnant, breastfeeding, or have a positive pregnancy test within 7 days before starting treatment.
• You have a history of serious mental illness or addiction to psychiatric drugs that cannot be resolved.
• You have other serious medical conditions or abnormal lab results that, in the opinion of the trial team, would make participation unsafe or affect the trial results.
• The trial team has any other reason to consider participation unsuitable for you.

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