Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma

Inclusion Criteria:

Patients must have:

Pathologically proven stage III melanoma with one or more macroscopic lymph node metastases (measurable according to RECIST v. 1.1) amenable to biopsy and/or surgery OR:
Patients considered to have stage III or stage IV disease amenable to serial biopsies as determined by the treating physician. Note: patients with in-transit metastasis may be eligible after surgical consultation if not surgical candidates.
Patients must have disease amenable to and must be willing to undergo protocol-directed repeat biopsies and blood draws.
Age > 18 years
ECOG performance status 0 or 1
Patients must have normal organ and marrow function

Exclusion Criteria:

Patients may not be receiving any other investigational agents
Patients with a known active autoimmune disease
Prior treatment with CTLA-4 or PD1/PD-L1 pathway targeted systemic treatment
Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids
Patients with ongoing diarrhea (> 4 bowel movements/day) unresolved despite medical and best supportive care in the two weeks preceding therapy