Prostaglandin Inhibition and Immune Checkpoint Blockade in Melanoma
Condition: Stage III Cutaneous Melanoma; Stage IIIA Cutaneous Melanoma; Stage IIIB Cutaneous Melanoma; Stage IIIC Cutaneous Melanoma; Stage IV Cutaneous Melanoma
MeSH terms: Melanoma; Skin Neoplasms
Intervention: Aspirin; Ipilimumab; Laboratory Biomarker Analysis; Pembrolizumab
Intervention description: Given PO; Given IV; Correlative studies; Given IV
Intervention MeSH terms: Aspirin; Pembrolizumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well pembrolizumab, ipilimumab, and aspirin work in treating
      patients with melanoma that has spread to other places in the body or cannot be removed by
      surgery. Monoclonal antibodies, such as pembrolizumab and ipilimumab, may interfere with the
      ability of tumor cells to grow and spread. Aspirin may stop the growth of tumor cells by
      blocking some of the enzymes needed for cell growth. Giving pembrolizumab, ipilimumab, and
      aspirin may work better in treating patients with melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed melanoma that is metastatic or
             unresectable and for which standard curative or palliative measures do not exist or
             are no longer effective

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

          -  Leukocytes >= 3,000/microliter (mcL)

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Total bilirubin within normal institutional limits

          -  Total bilirubin =< 1.5 X institutional upper limit

          -  Aspartate aminotransferase (AST) [serum glutamic-oxaloacetic transaminase (SGOT)] =<
             2.5 X institutional upper limit of normal

          -  Alanine aminotransferase (ALT) [serum glutamate pyruvate transaminase (SGPT)] =< 2.5 X
             institutional upper limit of normal

          -  Creatinine =< 1.5 X upper limit of normal (ULN)

          -  Women of childbearing potential should have a negative urine or serum pregnancy within
             72 hours prior to receiving the first dose of study drug; if the urine test is
             positive or cannot be confirmed as negative, a serum pregnancy test will be required

          -  Women of childbearing potential must be willing to use an adequate method of
             contraception, for the course of the study through 120 days after the last dose of
             study medication; Note: Abstinence is acceptable if this is the usual lifestyle and
             preferred contraception for the subject

          -  Men of childbearing potential must agree to use an adequate method of contraception,
             starting with the first dose of study therapy through 120 days after the last dose of
             study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and
             preferred contraception for the subject

          -  Ability to understand a written informed consent document, and the willingness to sign
             it

        Exclusion Criteria:

          -  Any mental or physical condition or disease or past medical history that mitigates
             against following the protocol

          -  History of active autoimmune diseases such as but not limited to Crohn?s disease,
             ulcerative colitis, Sjogren's syndrome, requiring active immune suppression; patient
             may have hay fever or controlled asthma

          -  Any solid organ transplant or bone marrow transplant

          -  Any other disseminated malignancy. Exceptions include: localized prostate cancer,
             basal or squamous cell skin cancer, localized cervical cancer, and localized breast
             cancer.

          -  Uncontrolled central nervous system (CNS) metastasis; patients with CNS metastasis can
             be eligible if definitively treated with radiotherapy or surgery

          -  Any coexistent medical condition interfering with drug absorption

          -  History of gastritis or malabsorption syndrome or aspirin intolerance or allergy

          -  Live vaccination within the last 30 days

          -  History of multiple sclerosis, type 1 diabetes mellitus (DM) or Guillain-Barre
             syndrome

          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the
             projected duration of the trial, starting with the screening visit through 120 days
             after the last dose of trial treatment