A Combination of Ipilimumab and Fotemustine for Treat Unresectable Locally Advanced or Metastatic Melanoma (NIBIT-M1)

This is an interventional treatment trial for Metastatic Malignant Melanoma focused on measuring metastatic melanoma, Ipilimumab Read More

Inclusion Criteria:

• Histologic diagnosis of malignant melanoma
• Stage III (unresectable) or Stage IV melanoma
• Maximum 1 line of chemotherapy for advanced disease allowed
• No prior chemotherapy within 4 weeks from treatment start (6 weeks in case of nitrosourea)
• No previous systemic corticosteroid therapy within 10 days
• Prior adjuvant treatment with IFN or other immunotherapy allowed
• Asymptomatic brain metastases allowed
• Measurable disease
• Prior treatment of brain metastases. In case stereotactic radiotherapy (or surgery) was not applicable, whole brain radiotherapy should have been performed
• Life expectancy >= 16 weeks
• ECOG performance status of 0 or 1
• Normal laboratory tests were required
• Negative screening tests for HIV, Hepatitis B, and Hepatitis C.
• Men and women, of and over 18 years old. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the study in such a manner that the risk of pregnancy is minimized.

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.

Other Exclusion Criteria

• Prisoners or subjects who are involuntarily incarcerated;
• Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.