Study on Pembrolizumab for Treating Cancer Spread to the Brain and Spinal Cord

Inclusion Criteria

• Must have a confirmed diagnosis of cancer from any solid tumor.
• Must have measurable cancer in the central nervous system (CNS), with at least one lesion 5 mm or larger.
• Must be 18 years or older.
• Must have a performance status that allows for daily activities with some limitations.
• Must have a life expectancy of more than 6 weeks.
• Must have normal organ and bone marrow function based on specific lab tests.
• Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for 120 days after the last dose.
• Men must agree to use effective contraception during the study and for 120 days after the last dose.
• Must be able to understand and sign a consent form.
• Must be on a stable dose of dexamethasone (2mg or less) for 7 days before starting treatment.
• May have progressive cancer outside the CNS.
• May have untreated spinal cord metastases if they are not causing symptoms.
• May have untreated brainstem metastases if they are small and not causing symptoms.
• Specific criteria for different groups of patients based on their cancer history and treatment status.

Exclusion Criteria

• Have had recent chemotherapy or other cancer treatments within 14 days before starting the study, unless side effects have resolved.
• Are receiving other investigational drugs.
• Have an immune system deficiency.
• Need high doses of corticosteroids (more than 2mg/day of dexamethasone) within 7 days of starting the study.
• Have had recent immunosuppressive treatments.
• Are allergic to Pembrolizumab or its ingredients.
• Have a history of active tuberculosis.
• Have uncontrolled illnesses or infections.
• Have psychiatric or substance abuse issues that would interfere with the study.
• Are pregnant or breastfeeding, or planning to conceive during the study period.
• Are HIV-positive and on antiretroviral therapy.
• Have another active cancer that requires treatment, except for certain skin cancers or cervical cancer.
• Have an active autoimmune disease requiring treatment in the past 2 years.
• Have a history of lung inflammation not caused by infection.
• Have an active infection needing treatment.
• Have had prior treatment with similar drugs to Pembrolizumab.
• Have active Hepatitis B or C.
• Have received a live vaccine within 30 days before starting the study.
• Cannot undergo an MRI of the brain.
• Are receiving other cancer treatments, except for certain allowed therapies.
• Need immediate surgery or radiation for brain metastases.
• Have acute bleeding in the CNS.