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 aged 18 or older who are able to understand and sign a consent form
• People who have been confirmed through a tissue test (biopsy) to have melanoma that cannot be surgically removed and is classified as stage III or stage IV
• People whose doctor has determined they are a candidate for standard treatment with two immunotherapy drugs called ipilimumab and nivolumab
• People who are generally well enough to carry out light daily activities, as measured by a standard medical scale (ECOG score of 0 or 1)
• People who have not received any prior treatment for this cancer, or who have received previous treatments — including targeted therapies, provided any small-molecule inhibitor drugs have been stopped at least two weeks before the trial starts
• People with a life expectancy of at least six months
• People who have at least one area of disease that can be safely biopsied during the study (this requirement may be waived by the lead doctor if a biopsy is not safely possible)
• People who are willing to have a tumour biopsy before and during the study, if no stored tumour tissue is already available
• People who are willing to provide a stored tumour tissue sample, if one is available, for research purposes
• People whose blood test results show that key organs are working within acceptable ranges, including white blood cell counts, platelet levels, haemoglobin, liver function, and other markers (confirm specific values with trial site)
• People who have at least one tumour that can be measured by CT or MRI scan at the start of the trial
• People who have previously had focused radiotherapy directed at a specific area
• Female participants of childbearing potential who have a negative pregnancy blood test within 72 hours before starting the study medication
• Female participants of childbearing potential who agree to use a highly effective form of contraception (such as a hormonal method or intrauterine device) combined with a condom used by their male partner, or who are surgically sterile, or who agree to abstain from heterosexual activity for at least six months after the last dose
• Male participants who agree to use an adequate method of contraception from the first dose through at least six months after the last dose

Who may not be able to join:

• People who have untreated brain metastases (cancer that has spread to the brain), unless specific conditions are met and the lead doctor approves involvement after specialist consultation (confirm details with trial site)
• People who are currently using corticosteroid (steroid) medications to manage immune-related side effects, or who have used them for this purpose within the past two weeks (low-dose steroids used as hormone replacement for adrenal insufficiency are generally permitted — confirm with trial site)
• People who have not fully recovered from side effects of a previous cancer treatment
• People who have previously had severe (grade 3–4) nerve or heart-related side effects, or life-threatening liver toxicity that did not respond well to steroids, from a type of immunotherapy called anti-PD-1 therapy
• People who have cancer that has spread to the membranes surrounding the brain and spinal cord (leptomeningeal disease)
• People who have an active autoimmune disease (where the immune system attacks the body) that is not related to prior cancer immunotherapy and has required ongoing medical treatment in the past year
• People who have medical reasons that prevent them from safely taking a drug called propranolol, including heart conditions such as cardiogenic shock, significant heart rhythm problems, severe asthma, known allergy to propranolol, a current need to take a different beta-blocker medication, uncontrolled diabetes, uncontrolled depression, or a heart attack or unstable chest pain within the past three months
• People enrolling into specific groups within the trial (Cohorts 2–4 only) who have medical reasons that prevent them from safely taking a drug called naltrexone — this includes people currently using opioid pain medications, people dependent on opioids, people in opioid withdrawal, or people with a known sensitivity to naltrexone
• People who are pregnant or breastfeeding
• People who have taken part in another clinical trial or used another experimental treatment or device within four weeks of the first dose
• People with other medical conditions, active infections requiring intravenous antibiotics, or abnormal test results that could make participation unsafe or make the results difficult to interpret
• People who have another active cancer at the same time, except for certain common skin cancers (squamous cell carcinoma or basal cell carcinoma of the skin)
• People who have active, non-infectious lung inflammation (pneumonitis)
• People with an active or chronic Hepatitis B or Hepatitis C infection
• People who have recently received a live vaccine (confirm timing with trial site)

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