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 have signed a written consent form approved by an ethics committee, agreeing to take part in the study.
• People aged 18 to 85 years old at the time of signing the consent form.
• People whose body weight is between 50 kg and 85 kg, and whose body mass index (BMI) falls between 18 and 30.
• People who have had one of the following cancers fully removed by surgery: non-small cell lung cancer (NSCLC), melanoma (skin cancer), or kidney cancer (renal cell carcinoma) at intermediate-high or high risk of coming back — including cases where kidney removal also involved removal of cancer that had spread.
• People who are in very good general health and able to carry out all normal activities without restriction, as assessed within 7 days before the first dose (confirm with trial site for exact scoring scale used).
• People expected to live for at least 12 weeks.
• People whose liver, kidneys, blood, and other organs are functioning well enough, as shown by recent blood tests — and who have not had blood transfusions or certain medical treatments within the 14 days before the first dose.
• Women who are post-menopausal (no periods for at least 1 year with no other known cause), or who have had surgical sterilisation (removal of ovaries and/or uterus).
• Women who are able to become pregnant, provided they have a negative pregnancy test within 7 days before joining, are not breastfeeding, and agree to use a highly effective form of contraception (with less than 1% annual failure rate) or remain abstinent from the time of signing consent until at least 6 months after the last dose.
• Men who agree to remain abstinent or use condoms during the study and for at least 6 months after the last dose, particularly if their partner is pregnant or could become pregnant.

Who may not be able to join:

• Women who are pregnant or currently breastfeeding.
• People who, in the investigator's judgement, have a history of illegal drug use or alcohol misuse in the 12 months before joining.
• People with NSCLC who have two separate primary lung cancers at the same time, certain other tissue types of lung cancer (such as mixed adenosquamous carcinoma, small cell lung cancer, or neuroendocrine carcinoma), or specific genetic markers known as EGFR sensitive mutations or ALK fusion.
• People with melanoma that started in the mucous membranes or in the eye.
• People with kidney cancer who have cancer that has spread to the brain or bones before surgery, or who still have a blood clot in the kidney vein or main abdominal vein after kidney removal.
• People who have had another active cancer within the past 5 years, or who currently have another active cancer.
• People who have had an organ or bone marrow transplant, or who are planned to have one during the study.
• People who have cancer that has spread to the brain or the lining of the brain or spinal cord.
• People who have had significant heart or brain blood vessel problems — such as a heart attack, poorly controlled irregular heartbeat (including specific abnormal heart rhythm readings on an ECG), or a stroke-related condition — within the 6 months before joining.
• People with severe chronic heart failure, or whose heart pumping function (measured by ultrasound) is below 50%.
• People with moderate or severe nerve damage affecting the hands or feet (peripheral neuropathy of Grade 2 or above — confirm with trial site for exact grading).
• People with a known or newly detected infection with HIV, active hepatitis B, active hepatitis C, co-infection with both hepatitis B and C, or active tuberculosis within the 6 months before joining.
• People with known lung conditions such as interstitial pneumonia, dust-related lung disease, radiation-related lung damage, or drug-related lung inflammation, or serious breathing problems that could make it difficult to detect lung side effects from the study drug.
• People with known serious allergic reactions to pembrolizumab, other similar antibody-based medicines, or ingredients in the study drugs.
• People with known active or suspected autoimmune diseases — though people with a stable autoimmune condition that does not require immune-suppressing medication may still be considered (confirm with trial site).
• People with an unstable thyroid condition (either overactive or underactive) at the time of screening.
• People who have received a live vaccine within 28 days before the first dose (standard inactivated flu vaccines are allowed).
• People who have been taking oral or injected corticosteroids at a dose above the equivalent of 10 mg per day of prednisone, or other immune-suppressing medicines, within 14 days before the first dose or during the study — though low-dose inhaled or topical steroids and certain hormone replacement therapies at low doses may be permitted (confirm with trial site).
• People who have had an active infection requiring treatment with systemic (whole-body) medication within 1 month before the first dose.
• People who are planning to have surgery during the trial (minor procedures such as tumour biopsy or lymph node biopsy are allowed).
• People who have previously been treated with pembrolizumab or similar immune checkpoint-blocking medicines (such as PD-1, PD-L1, or CTLA-4 inhibitors).
• People who have taken part in another clinical drug trial recently — specifically within 1 month before the first dose, or within 5 half-lives of the previous trial drug (whichever is longer) — or who plan to join another drug trial before completing all assessments in this study.
• People who have taken part in a medical device trial within 1 month before screening, or who are currently in or plan to join another surgical or device trial during this study.
• People for whom the investigating doctor has a clear reason to believe that joining the study would be harmful to them.

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