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Metronomic Cyclophosphamide with Pembrolizumab for Melanoma

This study is testing a combination of two drugs, Pembrolizumab and Cyclophosphamide, for people with advanced melanoma that has not responded to previous treatments. Pembrolizumab is given through an IV, and Cyclophosphamide is taken by mouth. Researchers want to see how many patients respond to this treatment (Objective Response Rate) and to track any side effects, including immune-related side effects, for up to three years. You may be able to join if you are at least 18 years old and have unresectable Stage III or Stage IV melanoma that can be measured by imaging. The study is currently recruiting about 14 participants.

Study design
This is a Phase 2, single-arm, open-label study, meaning all participants receive the same treatment and both you and the study team will know which drugs are being given. It aims to enroll 14 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to three years to assess treatment response and side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06771544

Metronomic Cyclophosphamide With Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of California, Irvine
~14 participants
Updated 2026-03-10 on ClinicalTrials.gov
What's tested:PembrolizumabCyclophosphamide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR) by RECIST v1.1
Measured over Up to 3 years
+4 more outcomes measured

Conditions

Melanoma
Melanoma Stage III
Melanoma (Skin)
Melanoma Stage IV

Explore related trials

MelanomaBRAF Gene

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Warren Chow, MD · PRINCIPAL_INVESTIGATOR · Chao Family Comprehensive Cancer Center

Who to contact

Chao Family Comprehensive Cancer Center University of California, Irvine
[email protected]
1-877-827-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 liver metastases. T Bilirubin \< 3.1 mg/dL.
Has progressed on a prior PD-1/PD-L1 treatment
Recovered from toxicities of pembrolizumab to Grade ≤1, excluding endocrine toxicities
Prior Receipt of PD-1/PD-L1 therapy within 9 weeks prior to the first dose of the investigational therapy.
Women of childbearing potential must have had a negative pregnancy test performed within 7 days prior to the start of treatment
Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study.
Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the trial screening date until 3 months after the final dose of study intervention; cessation of birth control after this point shall be discussed with a responsible physician.
Pregnant or lactating women are prohibited from enrolling in this study.
Male participants are not allowed to donate sperm from the time of enrollment until 6 months after administration of study interventions.
Presence of B-RAF driver mutation without prior receipt of BRAF +/- MEK inhibitors, unless patient declines BRAF +/-MEK inhibition for any reason or is unable to tolerate BRAF and/or MEK inhibitors.
Participants with a known history of chronic viral infections as indicated below. If patients do not have a known history, testing is not required during the screening period to confirm the patient has an active infection.
Known HBV infection defined as hepatitis B surface antigen reactive. NOTE: Participants with HBV infection on stable anti-viral therapy for \> 4 weeks prior to the planned first study intervention and viral load confirmed as undetectable during Screening may be eligible.
Known active HCV infection defined as detectable HCV RNA (qualitative) infection. NOTE: History of HCV is not exclusionary if participant has received curative treatment and viral load is confirmed as undetectable during Screening.
Active HIV infection. Those with HIV infections on combination antiretroviral medications with stable CD4 count \>200/microliters as measured within screening time period. If the patient does not have a known history of HIV, then testing is not required during screening to confirm presence or absence of HIV.
Positive serum pregnancy test
Participants with out-of-range screening laboratory values as defined below. NOTE: Hematology evaluations must be performed \>7 days from any blood transfusion. Or blood product transfusion or from any dose of hematologic growth factor.
Glomerular filtration rate (calculated using the Chronic Kidney Disease Epidemiology Collaboration formula) \< 30 mL/min
Total bilirubin \> 1.5 × ULN; participants with Gilbert's syndrome are excluded if total bilirubin \> 3.0 × ULN; or direct bilirubin \> 1.5 × ULN
Albumin \< 3.0 g/dL
Absolute lymphocyte count \< 0.5 × 10\^9/L
Participants with a history of allogeneic tissue/solid organ transplant

Exclusion

Participants with a diagnosis of ocular or metastatic uveal melanoma
Participants with a history of a malignant disease other than those being treated in this study. The following exceptions are permitted:
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.
Completely resected carcinoma in situ of any type
Participants ineligible to be retreated with pembrolizumab due to a treatment-related AE while on a prior anti-PD(L)-1 regimen that led to discontinuation of that prior therapy and would thus prevent retreatment or with an immune-related adverse event (irAE) of grade 3 or greater
Participants with known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. NOTE: Participants with previously treated brain metastases may participate provided ALL of the following apply:
Treated CNS lesions are radiographically stable (without evidence of progression for ≥ 28 days prior to the first dose of study intervention) after intervention (eg, surgery and/or radiation).
Neurologically stable and on stable dose of ≤ 10mg of prednisone equivalent steroids for at least 7 days prior to the first dose of study intervention.

What this trial measures

  • Objective Response Rate (ORR) by RECIST v1.1Up to 3 years

    Sum of Complete Response (CR) and Partial Response (PR) by RECIST v 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR

  • Number of Patients with Adverse EventsUp to 3 years

    Number of Patients who received at least one dose of Pembrolizumab with Cyclophosphamide with any reported Adverse Events (AEs) using the CTCAE version 5.0 for reporting of nonhematologic AEs and modified criteria for hematologic AEs.

  • Number of Patients with Immune Related Adverse EventsUp to 3 years

    Number of Patients who received at least one dose of Pembrolizumab with Cyclophosphamide with reported immune related AEs (irAEs) using the CTCAE version 5.0 for reporting of nonhematologic AEs and modified criteria for hematologic AEs.

  • Number of Patients who Discontinued Treatment Due to Reported Adverse EventsUp to 3 years

    Number of Patients who received at least one dose of Pembrolizumab with Cyclophosphamide requiring discontinuation of therapy due to reported AEs using the CTCAE version 5.0 for reporting of nonhematologic AEs and modified criteria for hematologic AEs..

  • Comparative Analysis of Immune CellsUp to 3 years

    Mean, median, percentage and total counts of immune T cell subsets pre-treatment and after 2 three-week cycles of metronomic cyclophosphamide and pembrolizumab.