Metronomic Cyclophosphamide With Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine
About this trial
This is a phase 2, single-arm, open label clinical trial determining efficacy of Cyclophosphamide and Pembrolizumab in subjects with melanoma.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Participants with a diagnosis of ocular or metastatic uveal melanoma
Malignancies that were treated curatively and have not recurred within 2 years. Shorter intervals can be considered after discussion with the Principal Investigator.
Completely resected basal cell and squamous cell skin cancers.
Any malignancy considered to be indolent and that has never required therapy, such as chronic lymphocytic leukemia.
Trial design
Treatments tested in this trial
- Pembrolizumab
- Cyclophosphamide
Treatment groups
14 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov