Melanoma Clinical Trial
Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
Phase I, open label, dose-escalation, and safety study designed to assess the safety and biologic activity of the investigational agent CBL0137 in combination with standard of care drugs, ipilimumab and nivolumab in sequential cohorts of adult patients with locally advanced and metastatic melanoma who are candidates for immune checkpoint blockade and have tumors accessible for serial biopsies.
The primary objectives will be Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.
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
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
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There is 1 Location for this study
Philadelphia Pennsylvania, 19111, United States More Info
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