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 have been diagnosed with one of the following cancers, confirmed by a lab test: (1) melanoma that has spread or cannot be surgically removed and has stopped responding to a type of immunotherapy called anti-PD-1 therapy; (2) kidney cancer (clear cell type) that has spread and has stopped responding to at least one PD-1/PD-L1 based treatment; or (3) melanoma that has spread or cannot be surgically removed and you have not yet received anti-PD-1 therapy.
• Your cancer can be measured on scans (confirm with trial site).
• You are 18 years of age or older.
• You are generally well enough to carry out daily activities with little or no limitation (confirm with trial site what this means for you).
• You are willing to use birth control from the time you join the study until four months after treatment ends.
• You have a negative pregnancy test before starting the trial.
• You have tested negative for HIV.
• You have tested negative for hepatitis B and hepatitis C (or if a hepatitis C test comes back positive, a follow-up test shows the virus is not active).
• Your blood counts and organ function (including liver, kidneys, and blood cells) meet certain minimum health levels as measured by blood tests (confirm specific values with trial site).
• At least four weeks have passed since you finished any previous cancer treatment.
• You are able to understand the study and are willing to sign a consent form agreeing to take part.
• You are willing to sign a Durable Power of Attorney form (a legal document related to the study).
• You are enrolled in a related study called protocol 03-C-0277 (confirm with trial site).

Who may not be able to join:

• You are currently breastfeeding.
• You are currently taking steroid medications (such as prednisone) on a regular basis.
• You have an active serious infection, a blood clotting disorder, or another significant uncontrolled medical condition.
• You have a condition where your immune system does not work properly from birth or due to disease (such as severe combined immunodeficiency or AIDS).
• You have a history of a serious autoimmune disease affecting a major organ.
• You previously had a severe immune-related side effect (grade 3 or 4) from anti-PD-1/PD-L1 therapy, such as serious inflammation of the heart, lungs, bowel, or liver.
• You currently have a serious opportunistic infection (an infection that occurs when the immune system is weakened).
• You have had a severe allergic reaction to pembrolizumab or aldesleukin in the past.
• You have a history of heart artery procedures (such as stents or bypass surgery) or symptoms of reduced blood flow to the heart.
• In some cases, if your heart pumping function has been tested and is below a certain level, you may not be eligible (confirm with trial site).
• In some cases, if your lung breathing capacity has been tested and is below a certain level, you may not be eligible (confirm with trial site).
• You are currently taking part in another clinical trial involving an experimental treatment.

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