Study of Pembrolizumab in Children with Advanced Solid Tumors or Lymphoma

Inclusion Criteria

• Age between 6 months and under 18 years.
• Have a type of cancer that is advanced, cannot be cured, and has not responded to standard treatments.
• Any number of previous treatments is allowed.
• Must have a tissue sample available for testing.
• Have advanced melanoma or a PD-L1-positive advanced, relapsed, or refractory solid tumor or lymphoma.
• Have measurable disease based on specific medical criteria.
• Children with neuroblastoma that can be detected by specific imaging may participate.
• Must have a performance score indicating they are active or able to do light activities.
• Must have adequate organ function.
• Female participants of childbearing age must have a negative pregnancy test before starting the study.
• Female participants must agree to use contraception or abstain from sex during the study and for 120 days after the last dose.
• Male participants must follow local guidelines for contraception use.
• Must demonstrate adequate organ function.

Exclusion Criteria

• Currently participating in another study or have used an investigational drug or device recently.
• Have an immune deficiency or are taking immune-suppressing medications.
• Have had recent cancer treatments or not recovered from previous treatment side effects.
• Have another progressing cancer that needs treatment, except for certain skin or cervical cancers.
• Have active cancer in the brain or spinal cord.
• Have severe allergies to pembrolizumab or its ingredients.
• Have an active autoimmune disease needing treatment in the past 2 years.
• Have a history of lung inflammation needing steroids.
• Have an active infection needing treatment.
• Are pregnant, breastfeeding, or planning to have children soon.
• Have had previous treatments targeting specific immune checkpoints.
• Have HIV, hepatitis B or C, or active tuberculosis.
• Have received a live vaccine recently.
• Have had a solid organ transplant or recent stem cell transplant.
• Have any condition or history that might interfere with the study or its results.
• Have psychiatric or substance abuse issues that would interfere with the study.