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:

General requirements (all participants):

• Adults aged 18 or older
• People who are generally well enough to carry out light activity and care for themselves (a doctor will assess this using a standard scale)
• People whose doctors estimate they have a life expectancy of at least 3 months
• People whose blood, kidney, liver, and heart are functioning well enough, based on recent lab tests
• People who have had previous cancer treatments, as long as enough time has passed since the last treatment and any side effects have largely settled
• People who have had major surgery at least 4 weeks before starting the trial, or certain types of radiotherapy within the required waiting periods
• People who are not taking high-dose steroid tablets (above a low daily threshold) in the 2 weeks before starting
• People who are able to use reliable contraception during the trial and for at least 120 days after the last dose of trial medication (this applies to people who could become pregnant, and their partners)
• People who are able to understand the trial information and agree to take part

For Stage I only (the early phase):

• People with a confirmed advanced solid tumour (any type) that has been growing or spreading, where standard treatments are not available or have been declined, and where the trial doctor considers experimental immunotherapy a reasonable option to explore
• People whose tumour can be safely sampled (biopsied) more than once during the trial
• People with measurable tumour(s) that can be tracked on scans

For Stage II – Cohort A (skin melanoma that has spread):

• People with a confirmed diagnosis of metastatic cutaneous (skin) melanoma
• People who have previously been treated with one of several specific immunotherapy drugs (pembrolizumab, nivolumab, nivolumab + ipilimumab, or nivolumab + relatlimab), and whose disease either stayed stable for at least 6 months or responded and then progressed
• People whose last dose of one of those specific immunotherapy drugs was given no more than 12 weeks before the screening visit, and who have not started any other treatment since
• People with brain metastases that have already been treated and have been stable on scans for at least 4 weeks, with no new or worsening symptoms, and who are either not on steroids or are on a low stable or reducing dose (confirm with trial site)
• People who have not had a severe (Grade 3 or higher) immune-related side effect that caused them to permanently stop a previous anti-PD1/PD-L1 immunotherapy
• People willing to receive pembrolizumab according to the approved prescribing schedule

For Stage II – Cohort B (uveal/eye melanoma that has spread):

• People with a confirmed diagnosis of metastatic uveal (eye) melanoma
• People who have previously received a treatment called tebentafusp, whose disease responded or stayed stable for at least 6 months, and who then had confirmed progression, with side effects from tebentafusp settled and at least 14 days since the last dose
• People who have also previously been treated with pembrolizumab, nivolumab, or nivolumab + ipilimumab, and whose disease either stayed stable for at least 6 months or responded and then progressed

Who may not be able to join:

General exclusions (all participants):

• People who are pregnant or breastfeeding
• People with serious uncontrolled illness, such as active infections requiring intravenous antibiotics, uncontrolled heart failure, unstable chest pain, a heart attack within the last 6 months, or uncontrolled high blood pressure
• People with HIV that is not well controlled, or active hepatitis B or C with high levels of virus in the blood despite treatment
• People with another active cancer currently requiring treatment (some exceptions apply, such as certain skin cancers or cancers that have been in remission for 2 or more years)
• People who have had a live vaccine (such as the yellow fever or shingles vaccine) within 28 days before starting
• People with a certain abnormal heart rhythm reading on an ECG (QTcF above 500 ms)
• People with an active autoimmune disease (where the immune system attacks the body's own tissues) that has required systemic treatment in the past 2 years — though some treatments such as creams, inhalers, or hormone replacement are allowed
• People who have previously received certain types of immunotherapy or experimental cancer vaccines, other than the specific drugs listed as permitted for this trial
• People with a known allergy to any ingredient in the trial drug
• People whose overall health or circumstances, in the trial doctor's judgement, would make participation unsafe or difficult

For Stage I only:

• People who had chemotherapy, biological therapy, hormonal anti-cancer treatment, or radiation within 4 weeks before screening (or 6 weeks for certain chemotherapy types), unless the medication leaves the body very quickly
• People whose cancer involves major airways, large blood vessels, or the central chest area in a way that could cause dangerous bleeding or tearing if the tumour breaks down, or whose cancer is in the bowel wall where tumour breakdown could cause a perforation
• People who used another experimental treatment within 4 weeks or 5 half-lives before the first trial dose (whichever is shorter)
• People who had major surgery within 14 days before starting
• People with a history of another cancer, unless it was fully treated with no signs of active disease for at least 2 years, or was a minor skin cancer or early-stage cervical cancer that was adequately treated
• People taking immune-suppressing medications (such as high-dose steroids, certain arthritis drugs, or anti-inflammatory biologics) within 2 weeks before starting
• People taking hormone-blocking treatments (such as those used in some prostate cancers) within 2 weeks before starting
• People with ongoing side effects from previous treatments rated Grade 2 or higher, with some exceptions (such as stable nerve damage, hair loss, or stable hormone conditions managed with replacement therapy)
• People with a history of certain immune system conditions (such as lupus, multiple sclerosis, rheumatoid arthritis, myasthenia gravis, inflammatory bowel disease, or similar conditions)
• People with significant heart problems, including severe heart failure, a heart attack within 6 months, or unstable chest pain within 6 months
• People with a history of severe allergic reactions
• People with known hypersensitivity to any component of the trial drug
• People with uncontrolled seizures
• People with a history of significant clotting or bleeding disorders, or abnormal clotting blood test results
• People with any other condition, history, or situation that the trial doctor believes could affect their safety or the reliability of the trial results

For Stage II – Cohort A (skin melanoma) only:

• People who had a severe or life-threatening immune-related reaction to immunotherapy that caused them to permanently stop that treatment (some exceptions for manageable hormone-related side effects)
• People with current or past lung inflammation (interstitial lung disease or pneumonitis) that required steroid treatment
• People receiving other active anti-cancer treatments at the same time (outside of what the trial allows for supportive care)
• People with confirmed acral melanoma (melanoma on palms, soles, or under nails) or mucosal melanoma (melanoma on inner body surfaces)

For Stage II – Cohort B (uveal/eye melanoma) only:

• People with active, uncontrolled liver problems not caused by the cancer itself (such as acute hepatitis)
• People with melanoma that has spread to the brain
• People with any specific contraindication to the trial drug as assessed by the trial doctor (confirm with trial site)

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