Metronomic Cyclophosphamide With Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma
University of California, Irvine
Summary
This is a phase 2, single-arm, open label clinical trial determining efficacy of Cyclophosphamide and Pembrolizumab in subjects with melanoma.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugPembrolizumab
Given IV
- DrugCyclophosphamide
Given PO
Location
- Chao Family Comprehensive Cancer Center University of California, IrvineOrange, California