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:

• People who have signed and provided written consent to participate.
• People with an advanced solid tumour (confirmed by tissue testing) that can be measured or detected on scans or fluid samples — this applies to most parts of the trial except the melanoma combination group.
• People with metastatic skin melanoma (confirmed by tissue testing) whose cancer has progressed after no more than 2 previous treatments for advanced disease, and who have previously received a type of immunotherapy called a PD-1/PD-L1 treatment — this applies to the combination treatment group only.
• People with relapsed or treatment-resistant lymphoma (including various B-cell, Hodgkin's, and T-cell types) where standard treatments are no longer working or do not exist, with disease that can be measured in two directions on scans — this applies to the lymphoma group only.
• People with solid tumours in certain parts of the trial who have received no more than 3 previous treatments for metastatic disease.
• People aged 18 or older (there is no upper age limit).
• People whose general physical fitness is rated at 0 or 1 on a standard oncology scale, meaning they are either fully active or have minor restrictions in strenuous activity (confirm with trial site).
• People with a life expectancy of at least 12 weeks.
• People with adequate bone marrow, liver, and kidney function as measured by blood tests.
• People who are able to follow the requirements of the trial protocol.
• People of childbearing potential who have a negative blood pregnancy test within 3 days before starting the study drug, and who agree to use two forms of contraception (including one highly effective method) from screening until 6 months after the last dose, or to practise complete abstinence during that period.
• People in certain early-stage parts of the trial who are willing to have a tumour biopsy before and during treatment (exceptions may be considered if a biopsy poses unacceptable risk — the trial's medical monitor would assess this individually).
• People who have been advised to protect their skin and eyes from UV light, including avoiding sunbathing and solariums, for the entire duration of the trial and for 4 weeks after the last dose.

Who may not be able to join:

• People who have had an allergic reaction to any ingredient in NUC-7738.
• People with cancer that has spread to the brain or the lining of the brain and spinal cord — although people with brain metastases may be eligible if they have no ongoing neurological symptoms, have not used steroid medications in the 7 days before joining, and whose brain scans have been stable for at least 2 weeks.
• People who have received chemotherapy, radiation therapy (other than a short course for bone pain), immunotherapy, or another experimental treatment within 28 days before starting the study drug (longer waiting periods apply for certain specific drug types, including 6 weeks for some chemotherapy agents and 14 days for hormone therapies).
• People who still have significant side effects (rated above Grade 1 on a standard scale) from previous cancer treatments, with the exception of nerve damage, hearing problems, or hair loss, which must be below Grade 3.
• People with serious uncontrolled medical conditions that the doctor believes would interfere with the trial, including: severe heart failure, a heart attack within the past 6 months, poorly controlled chest pain, certain abnormal heart rhythm findings on an ECG, a history of or risk factors for a specific dangerous heart rhythm problem, or a history of lung inflammation or scarring.
• People known to be HIV positive, or who have active hepatitis B or C, or a current bacterial or viral infection including shingles or chickenpox.
• People whose circumstances (such as difficulty following instructions, psychological factors, or location) may prevent them from properly participating or giving informed consent, in the doctor's judgement.
• People who are currently pregnant, breastfeeding, or lactating.
• People whose heart's electrical activity (QTc interval) is above a certain threshold on an ECG — above 450 milliseconds for males or 470 milliseconds for females.
• People currently taking medications known to affect heart rhythm in a specific way (QT/QTc prolongation).
• People currently taking certain medications that strongly affect how the body processes drugs (strong CYP3A4 inducers or inhibitors), or who have taken these within 2 weeks (inducers) or 1 week (inhibitors) before starting the study drug.
• People who have received a live vaccine within 4 weeks of the planned first dose.

For the combination immunotherapy group (NUC-7738 + pembrolizumab) only, additional exclusions apply:

• People with a known allergy or medical reason to avoid any ingredient in pembrolizumab.
• People for whom immunotherapy with checkpoint inhibitor drugs is medically contraindicated.
• People currently taking systemic steroid therapy or immune-suppressing medications at or above a certain dose.
• People who have developed antibodies that neutralise checkpoint inhibitor drugs.
• People previously treated with checkpoint inhibitors whose skin side effects have not been adequately treated, or who do not have appropriate replacement therapy for hormone-related side effects.
• People who had to stop checkpoint inhibitor treatment in the past due to side effects — though these cases may be reviewed individually by the medical monitor.
• People with an active autoimmune disease or a history of one (including ulcerative colitis or Crohn's disease), or any condition requiring ongoing steroid treatment.
• People who have previously received cell-based therapies.

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