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:

• Adults aged 18 or older, of any gender
• People who are willing and able to provide written consent to participate, along with any other authorisations required by local law
• People who have a relatively good level of general physical functioning (rated 0 or 1 on a standard scale used by doctors to measure this)
• People who have been confirmed through laboratory testing to have an advanced or spreading solid tumour cancer — the specific cancer types allowed depend on which phase of the trial is involved (confirm with trial site)
• People whose cancer has continued to grow despite standard treatment, or for whom standard treatment is not available or suitable (as determined by the treating doctor)
• People who have at least one measurable area of cancer that has not previously been biopsied or treated with radiation
• People who have a tumour site that can be safely biopsied before and during treatment (this is required)

Who may not be able to join:

• People with a history of another separate cancer diagnosis
• People with brain metastases causing symptoms that require more than a certain dose of steroid medication (specifically more than 10 mg per day of prednisolone or an equivalent)
• People who have had a serious heart event such as a heart attack or blood clot within the 6 months before starting the study, or who have certain significant heart rhythm or electrical problems (applies to Phase 1a and Phase 2 monotherapy portions)
• People who have any level of breathing difficulty, whether caused by cancer or another condition
• People who currently have an active bacterial, fungal, or viral infection affecting the whole body
• People who have received a live vaccine in the 30 days before joining
• People who have had major surgery within 4 weeks of starting the study
• People who have previously had a solid organ transplant or a bone marrow stem cell transplant
• People who have previously received very high-dose chemotherapy that required stem cell support to recover
• People with a history of active autoimmune conditions (where the immune system attacks the body)
• People currently using immune-suppressing medications, including steroid tablets or steroid medications taken by mouth
• People who have received an approved cancer treatment or an experimental treatment within 4 weeks before the study start date
• People who have tested positive for COVID-19 (SARS-CoV-2) within 28 days before the first dose, unless the treating doctor has confirmed full recovery by the start date
• People with a condition called adrenal insufficiency (where the adrenal glands do not produce enough hormones)
• People whose blood test results for kidney, liver, or blood cell function fall outside an acceptable range (Grade 2 or worse on a standard medical grading scale)

The following additional restrictions apply to the combination therapy portion of the trial only:

• People with active cancer spread to the brain or the lining of the brain (though people with previously treated and now stable brain metastases who have not needed steroid treatment for at least 14 days may be considered — confirm with trial site)
• People who have received radiation therapy within 2 weeks of starting the study, or who have a history of radiation-related lung inflammation
• People who have an active autoimmune disease that has required systemic medication within the past 2 years (note: standard hormone replacement therapies such as thyroid or insulin treatment are generally not considered to be a disqualifying systemic treatment — confirm with trial site)
• People who previously received certain immunotherapy drugs (targeting PD-1, PD-L1, PD-L2, CTLA-4, OX40, or CD137) and had to stop that treatment due to a serious immune-related side effect (Grade 3 or higher)
• People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients (some exceptions may be considered after discussion with the study medical team — confirm with trial site)
• People with a history of non-infectious lung inflammation that required steroid treatment, or who currently have lung inflammation
• People who have received high-dose radiation to the lungs (more than 30 Gy) within 6 months before the first dose

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