Phase 3 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 are 18 years of age or older at the time of signing the consent form.
• People who are expected to live for at least 3 months.
• People who have been diagnosed (confirmed by tissue or cell testing) with Stage 3 (unable to be surgically removed) or Stage 4 melanoma that has spread, and whose treating doctor considers them suitable for standard treatment with the drug pembrolizumab.
• People who have at least one measurable tumour that can be detected by CT or MRI scan at the start of the trial.
• People whose melanoma has been tested for a specific gene change called BRAF V600, or who agree to have that test done during the screening period.
• People who have finished any prior radiotherapy at least 2 weeks before starting the trial treatment.
• People whose general physical functioning is rated at 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity — confirm with trial site).
• People whose blood, liver, and organ function results are within acceptable ranges, based on tests done within 10 days of starting treatment.
• Women who could become pregnant must have a negative pregnancy blood test within 72 hours before the first dose of trial treatment.
• Women who could become pregnant (and have not been through menopause for more than 2 years, or have not had a hysterectomy or surgical sterilisation) must agree to use two reliable methods of contraception, or one reliable method plus a hormonal method, or to avoid sexual activity with a male partner, from the start of the trial until 120 days after the last dose.
• Men who are sexually active with a partner who could become pregnant must agree to use an approved method of contraception from the start of the trial until 120 days after the last dose.
• People who are willing and able to give written informed consent to take part.

Who may not be able to join:

• People whose melanoma originated in the eye.
• People who are currently in another clinical trial involving an investigational treatment, or who received such a treatment within the past 4 weeks or 5 half-lives of that drug (whichever is shorter).
• People who have already received a systemic (whole-body) treatment for advanced melanoma before the first dose of trial treatment. Note: prior treatments given before or after surgery (adjuvant or neoadjuvant) may be allowed in certain circumstances — confirm with trial site.
• People who experienced a serious (Grade 3 or higher) side effect while previously receiving anti-PD-1 therapy.
• People who have had major surgery within 3 weeks before the first dose.
• People who have received a live-virus vaccine within 30 days before the first dose.
• People with a history of another cancer, unless they received treatment aimed at curing it and have had no sign of it returning for at least 5 years.
• People with currently active cancer that has spread to the brain or the lining around the brain. People who have had previously treated brain metastases may be considered if they have been stable for at least 4 weeks with no new or growing spots, and have not needed high-dose steroid treatment for at least 2 weeks before starting the trial.
• People whose heart's electrical activity (measured by ECG) shows a prolonged interval beyond a set threshold (confirm with trial site).
• People who have an active autoimmune disease that has needed systemic (whole-body) treatment in the past 2 years. Some conditions such as Type 1 diabetes, an underactive thyroid on hormone replacement, vitiligo, psoriasis, or alopecia may be permitted if no systemic treatment is currently required.
• People who are currently taking, or have taken within 14 days of starting the trial, regular oral or injected steroids or other immune-suppressing medications. Some exceptions may apply — confirm with trial site.
• People with a history of lung inflammation (pneumonitis) or scarring lung disease (interstitial lung disease) that required steroid treatment, or who currently have either of these conditions.
• People who have an active infection that is currently being treated.
• People with uncontrolled HIV infection. People with HIV that is well managed may be considered.
• People who test positive for active hepatitis B or hepatitis C virus infection.
• People with any significant medical condition, ongoing treatment, or abnormal test result that could interfere with the trial results or their ability to take part for the full duration.
• People with a known psychiatric condition or substance use disorder that would make it difficult to follow the trial requirements.
• People with a known history of regular illicit drug use, or a recent history (within the past year) of substance misuse, including alcohol.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period.
• People who are currently taking certain medications known to strongly affect the way specific liver enzymes (CYP3A4 and CYP1A2) process drugs — confirm specific medications with the trial site.

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