A Combination of Ipilimumab and Fotemustine for Treat Unresectable Locally Advanced or Metastatic Melanoma

Exclusion Criteria

• •Any malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix;
• •Primary ocular or mucosal melanoma. Medical History and Concurrent Diseases
• •Symptomatic brain metastases requiring immediate local intervention (radiotherapy (RT) and/or surgery)
• •Autoimmune disease
• •Any underlying medical condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea.
• •Prohibited Treatments and/or Therapies
• •Concomitant therapy with any anti-cancer agent
• •Immunosuppressive agents
• •Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month prior to or after any dose of study drug); surgery or radiotherapy ; other investigational anti-cancer therapies; or chronic use of systemic corticosteroids ;
• •Previous treatment with other investigational products, including cancer immunotherapy, within 30 days;
• •Previous enrollment in another clinical trial or prior treatment with a CD137 agonist or anti-CTLA-4 and/or fotemustine.
• •Sex and Reproductive Status
• •WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study;
• •Women who are pregnant or breastfeeding;
• •Women with a positive pregnancy test on enrollment or prior to investigational product administration;
• •Sexually active fertile men not using effective birth control if their partners are WOCBP.
• •Prisoners or subjects who are involuntarily incarcerated;
• •Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.