Early 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:

• You are willing and able to sign a written consent form to take part in the trial.
• You are 18 years of age or older at the time of signing the consent form.
• You have been diagnosed with a specific advanced stage of melanoma (pT3b, T4a, or T4b) confirmed by a biopsy, with visible remaining tumor or tumor cells found at the edges of the biopsy — note that melanoma starting in the eye (uveal melanoma) does not qualify.
• If you are a woman who could become pregnant, you must have a negative pregnancy blood test during screening and before your first dose, and a negative urine pregnancy test on each treatment day.
• If you are a woman who could become pregnant, you must agree to use highly effective birth control and avoid becoming pregnant until at least 90 days after your last dose of the study drug.
• If you are a man who could father a child, you must agree to use highly effective birth control, avoid getting a partner pregnant, and not donate sperm until at least 90 days after your last dose of the study drug.
• You are generally healthy and active enough to carry out daily activities, based on a standard health performance scale (a score of 0 or 1 out of 5, where 0 means fully active and 1 means slightly restricted in strenuous activity).
• Your kidneys, liver, and other organs are working well enough, confirmed by blood tests taken within 30 days before starting treatment.

Who may not be able to join:

• You have previously been treated with a type of cancer therapy that uses a modified virus (called an oncolytic virus therapy).
• You have an active or chronic hepatitis B or C infection, a known history of hepatitis B, active hepatitis C, or an HIV infection.
• You have had a serious infection that required antibiotics given through a drip (IV) or another serious infection within the 14 days before starting the study drug.
• You currently have an active herpes infection or have had serious complications from the HSV-1 herpes virus in the past, such as herpes affecting your eyes or brain.
• You are taking high-dose steroid medicines (more than the equivalent of 10 mg of prednisone per day) for reasons other than replacing hormones your body cannot make, within 14 days of enrolling in the trial.
• You have had major surgery within one week before starting the study drug, or have not fully recovered from a recent major surgery.
• You are currently taking part in, or have taken part in, another clinical trial involving an experimental treatment or device within the four weeks before your first dose in this study.
• You have had an allergic reaction or a severe sensitivity reaction to the study drug (RP1) or any of its ingredients in the past.
• You have received a live vaccine (such as measles, mumps, chickenpox, yellow fever, or nasal flu spray) within 30 days before your first dose — note that standard injected flu vaccines and available COVID-19 vaccines are generally allowed.
• You have any other medical condition, treatment history, or lab result that the trial doctor believes would make it unsafe or unsuitable for you to participate.
• You have serious or poorly controlled medical conditions.
• You have known mental health conditions, alcohol dependency, or substance misuse issues that would make it difficult to follow the study requirements.
• You are currently subject to a court or government order restricting your freedom, or are under a legal protection measure as an adult.
• You have received a transplanted solid organ (such as a kidney, liver, or heart).
• You have another cancer that currently requires active treatment with systemic therapy or ongoing radiation.
• Your tumor is located near critical structures such as major blood vessels (e.g., carotid artery), or has features such as significant bone erosion or possible involvement of the heart or other vital structures that make it unsafe to inject (confirm with trial site).

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