Metronomic Cyclophosphamide With Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a phase 2, single-arm, open label clinical trial determining efficacy of Cyclophosphamide and Pembrolizumab in subjects with melanoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Chao Family Comprehensive Cancer Center University of California, Irvine
RECRUITING
Orange
Contact Information
Primary
Chao Family Comprehensive Cancer Center University of California, Irvine
ucstudy@uci.edu
1-877-827-8839
Backup
University of California Irvine Medical
Time Frame
Start Date: 2024-12-23
Estimated Completion Date: 2028-12
Participants
Target number of participants: 14
Treatments
Experimental: Pembrolizumab + Cyclophosphamide
Pembrolizumab 200mg IV every 21 days or 400 mg IV every 42 days Cyclophosphamide 50mg PO daily on days 1-14 every 21 days for melanoma patients
Related Therapeutic Areas
Sponsors
Leads: University of California, Irvine

This content was sourced from clinicaltrials.gov

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