Actively Recruiting
Metronomic Cyclophosphamide With Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma
Led by University of California, Irvine · Updated on 2026-03-10
14
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase 2, single-arm, open label clinical trial determining efficacy of Cyclophosphamide and Pembrolizumab in subjects with melanoma.
CONDITIONS
Official Title
Metronomic Cyclophosphamide With Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing informed consent
- Unresectable Stage III or Stage IV non-ocular melanoma not suitable for local therapy
- Measurable disease by RECIST v1.1 criteria with progression in previously irradiated lesions allowed
- ECOG performance status of 0, 1, or 2 at screening
- Life expectancy of at least 12 weeks
- Adequate bone marrow, liver, and kidney function
- Hemoglobin level at least 9.0 g/dL
- Platelet count at least 100/mm3
- Absolute neutrophil count at least 1.5/mm3
- Creatinine clearance of at least 30 mL/min (Cockcroft-Gault formula)
- AST and ALT less than 3 times the upper limit of normal or less than 5 times with liver metastases
- Total bilirubin less than 3.1 mg/dL
- Disease progression after prior PD-1/PD-L1 treatment
- Recovery from pembrolizumab toxicities to Grade 1 or lower, excluding endocrine toxicities
- Prior PD-1/PD-L1 therapy received within 9 weeks before first dose of study treatment
- Negative pregnancy test within 7 days before treatment for women of childbearing potential
- Willingness to use effective contraception during and after study treatment
- Male participants agree to avoid sperm donation from enrollment until 6 months after treatment
You will not qualify if you...
- Diagnosis of ocular or metastatic uveal melanoma
- History of other malignant diseases except certain cured or indolent cancers
- Ineligibility for pembrolizumab retreatment due to prior severe immune-related adverse events
- Untreated or symptomatic brain metastases or carcinomatous meningitis
- Prior treatments other than PD-1/PD-L1, chemotherapy, or radiation within 6-9 weeks of study start
- Presence of B-RAF mutation without prior BRAF +/- MEK inhibitor treatment unless declined or intolerant
- Known active chronic viral infections such as untreated HBV, active HCV, or active HIV infections
- Positive pregnancy test
- Abnormal lab values including low kidney function, high bilirubin, low albumin, or low lymphocyte count
- History of allogeneic tissue or solid organ transplant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
Research Team
C
Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
U
University of California Irvine Medical
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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