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:

• You are 18 years of age or older
• Your cancer has continued to grow or spread after standard treatments, or your doctor believes standard treatments are unlikely to help you
• Your cancer type fits one of the following groups: any advanced or spreading cancer (Phase 1); advanced melanoma with no more than 3 previous treatments (Arm A); advanced head and neck cancer that has stopped responding to platinum chemotherapy and certain immunotherapy drugs (Arm B); sarcoma with no more than 3 previous treatments (Arm C); advanced skin squamous cell cancer with no more than 3 previous treatments (Arm D); advanced or returning non-small cell lung cancer without certain specific gene changes, with between 1 and 3 previous treatments (Arm E)
• Your cancer can be measured on scans using standard methods
• You have at least one tumor that a doctor can inject medication into directly
• You are generally able to carry out everyday activities with little or no limitation (confirm with trial site)
• Your doctors expect you to live for more than 12 weeks
• Your liver, kidneys, and other organs are working well enough based on blood tests
• If you could become pregnant, you are willing to use reliable contraception before, during, and for 6 months after treatment, and you have a negative pregnancy test before starting; men must also agree to use contraception during this period
• It has been at least 21 days since your last cancer treatment, radiation, or surgery
• You have recovered from any side effects caused by previous cancer treatments
• You are willing to provide a fresh tumor tissue sample as required by the study
• You are able to understand and follow the study requirements
• You have signed a consent form after being fully informed about the trial

Who may not be able to join:

• All of your tumors are in locations where they cannot be injected
• You have tumors that are pressing on major airways or blood vessels
• For head and neck cancer patients only: you previously received repeat radiation treatment to an area that includes a major neck artery
• You have more than 3 areas of spread to distant lymph nodes or other sites, or your largest distant tumor is bigger than 3 cm (or 5 cm for sarcoma), unless that specific tumor is the one being injected
• You have previously been treated with a virus-based cancer therapy (such as T-VEC), a cancer vaccine, cell therapy, or gene therapy
• You previously had a serious reaction to certain immunotherapy drugs, or have had lung inflammation caused by immunotherapy
• You have previously received a combination of certain immunotherapy drugs together with IL-12
• You currently need ongoing medication to treat herpes simplex virus (HSV) infections
• You have received a live or weakened live vaccine within the 4 weeks before starting the study
• You have a condition that weakens your immune system, either from birth or developed over time
• You are pregnant or currently breastfeeding
• You have previously had an organ transplant
• You currently have an active hepatitis B, hepatitis C, or HIV infection, or recent positive test results for these
• You have an active autoimmune disease or a condition that has required steroid or immune-suppressing medication in the past 4 weeks
• You have a history of cancer spreading to the brain or spinal cord, or currently have this
• You have had seizures within the past 6 months
• You currently have an active herpes sore on your mouth or skin
• You have active lung inflammation or a history of lung inflammation that required steroid treatment
• You have significant heart problems, including heart failure, active coronary artery disease, unexplained new chest pain within 3 months, unstable chest pain, or serious irregular heartbeat
• You have had an allergic reaction to substances similar to those used in this trial, including HSV-1, IL-12, or certain immunotherapy drugs
• You currently have an active COVID-19 infection
• You have a moderate or large build-up of fluid around your lungs, in your abdomen, or around your heart that requires treatment
• You have other significant health conditions that your doctor believes could interfere with the study (confirm with trial site)

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