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 aged 18 or older who give written consent to participate (or have a legal representative do so on their behalf).
• People who have been confirmed through laboratory testing to have melanoma that cannot be surgically removed and has spread, at certain stages of the disease — including some people whose melanoma has spread to a limited number of sites such as the lung, liver, bone, or brain (up to 10 lesions total), as well as people with a type of melanoma called acral lentiginous melanoma.
• People whose melanoma stopped responding to a type of immunotherapy drug called an anti-PD-1 or anti-PD-L1 treatment — either from the start or after an initial response — and who received at least 2 doses of that treatment before the disease progressed.
• People whose melanoma has a specific genetic change called a BRAF mutation, who received targeted therapy drugs (BRAF/MEK inhibitors) or declined them, and then received anti-PD-1 immunotherapy that the cancer stopped responding to — with that immunotherapy being the most recent treatment received before joining the trial.
• People who have at least one tumour that can be measured on scans, and at least one skin, under-skin, or lymph node tumour lesion that is large enough to be injected directly (5mm or more in size, or multiple smaller lesions adding up to that size).
• Women who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use highly effective contraception during treatment and for at least 120 days after the last dose of the study treatment.
• People who can provide a tumour tissue sample — either from a stored sample or a newly obtained biopsy — from a site that has not previously been treated with radiation.
• People who are in good enough general health to be active and carry out light daily activities (a general health score of 0 or 1 on a standard medical scale).
• People whose liver, kidneys, blood, and other organs are functioning well enough, confirmed by blood tests taken within 14 days before starting treatment.
• People who can provide a lymph node biopsy sample for research testing, either from stored tissue or a new biopsy, before starting the trial.
• People who have tested negative for HIV, hepatitis B (HBV), and hepatitis C (HCV) (with additional blood tests required if there are signs of past hepatitis B exposure).
• People whose side effects from any previous cancer treatment have mostly resolved — generally to a mild or baseline level — before starting the trial, and who have not needed treatment for immune-related side effects for at least 4 weeks before joining.
• People who have not had severe immune-related side effects (at the most serious levels, Grade 4, or Grade 3 needing more than 4 weeks of treatment) from previous immunotherapy.
• Male participants whose partners could become pregnant must agree to use two forms of contraception at the same time from the screening period until three months after the last dose, and must not donate sperm during treatment.
• People who are willing and able to attend scheduled visits and follow the study plan.

Who may not be able to join:

• People who have more than 10 melanoma lesions spread to the lung, liver, bone, or brain combined, or who have brain lesions causing symptoms or growing or bleeding rapidly.
• People with certain types of melanoma, including uveal melanoma (melanoma of the eye), mucosal melanoma (melanoma in body linings such as the mouth or nose), or melanoma where the original location is unknown.
• Women who could become pregnant and have a positive pregnancy test within 72 hours before starting treatment.
• People who previously had to stop an immunotherapy treatment (including anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint drugs such as those targeting CTLA-4, OX-40, or CD137) because of a severe immune-related side effect (Grade 3 or higher).
• People who have received other systemic cancer treatments or participated in another investigational study within 4 weeks before the first dose (confirm with trial site for exact timing rules).
• People who have had radiation therapy within 2 weeks before starting the trial, or who have a history of radiation-related lung inflammation.
• People who have had a stem cell transplant from a donor within the last 5 years, or who still have symptoms of graft-versus-host disease from a transplant done more than 5 years ago.
• People who have ever received an organ or tissue transplant from another person.
• People who have received a live or live-attenuated vaccine within 30 days before the first dose (certain approved COVID-19 vaccines are allowed — confirm with trial site).
• People who have a condition that weakens the immune system, or who are taking steroid medication at doses above 10mg of prednisone per day (or equivalent), or any other immune-suppressing medication within 7 days before the first dose.
• People who have another cancer that is currently active or required treatment within the past 2 years (certain minor or treated skin cancers may be exceptions — confirm with trial site).
• People who have active, untreated cancer spread to the brain or the lining of the brain. People with previously treated and stable brain metastases may be considered if they have not needed steroid treatment for at least 14 days and imaging confirms no progression for at least 4 weeks.
• People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients, or to certain immune-related substances including IL-2 or TNF.
• People who have an active autoimmune disease that required systemic treatment (such as immune-suppressing drugs) within the past 2 years. (Hormone replacement therapy for conditions such as thyroid or adrenal insufficiency is generally not considered systemic treatment in this context — confirm with trial site.)
• People who have a history of or currently have serious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment.
• People who currently have an active infection requiring treatment with medication.
• People who have a medical condition, mental health condition, or substance use disorder that could interfere with their ability to participate fully or safely, as determined by the treating doctor.
• People who have previously been enrolled and randomly assigned to a treatment group in this same trial.

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