Metronomic Cyclophosphamide With Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma
Trial Parameters
Brief Summary
This is a phase 2, single-arm, open label clinical trial determining efficacy of Cyclophosphamide and Pembrolizumab in subjects with melanoma.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years at the time of signing informed consent form (ICF) * Patients must have unresectable Stage III or Stage IV non-ocular melanoma per American Joint Committee on Cancer 8th Edition Staging Criteria not amenable to local therapy * Participants must have measurable disease by RECIST v1.1 criteria as assessed by investigator/ radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions. * Participants must have Eastern Cooperative Group (ECOG) performance status score of 0, 1 or 2 at screening visit. * Life expectancy of at least 12 weeks * Adequate bone marrow, liver, and renal function * Hemoglobin ≥9.0 g/dL * Platelets ≥100/mm3 * ANC ≥1.5/mm3 * Creatinine Clearance ≥ 30mL/min Cockcroft-Gault CrCl, mL/min = (140 - age) × (weight, kg) × (0.85 if female) / (72 × Cr, mg/dL). * AST and ALT less than 3 times the Upper Limit of Normal or less than 5 times the Upper Limit of normal with live