Study on Metronomic Cyclophosphamide and Pembrolizumab for Melanoma Resistant to Checkpoint Inhibitors

Sponsor: University of California, Irvine

Sponsor score: 40

ClinicalTrials ID:NCT06771544

This clinical trial is testing a combination of two drugs, Cyclophosphamide and Pembrolizumab, to see if they can effectively treat melanoma that has not responded to previous treatments. The study is open to adults with advanced melanoma that cannot be surgically removed.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of a drug combination, Cyclophosphamide and Pembrolizumab, in treating patients with advanced melanoma that has not responded to other treatments. This is a phase 2 trial, meaning it focuses on how well the treatment works and its safety in a small group of participants.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced melanoma that cannot be removed by surgery.
  • Have measurable cancer as determined by medical scans.
  • Be in relatively good health with a performance status score of 0, 1, or 2.
  • Have a life expectancy of at least 12 weeks.
  • Have adequate bone marrow, liver, and kidney function.
  • Meet specific blood test requirements, including hemoglobin, platelet, and neutrophil counts.
  • Have recovered from previous pembrolizumab treatment side effects, except for certain hormone-related issues.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.
  • Agree to use effective birth control during the study and for a specified time after.
  • Men must not donate sperm during the study and for six months after treatment.

Exclusion Criteria

  • Have a type of melanoma affecting the eyes or a history of other cancers, with some exceptions.
  • Have untreated or symptomatic brain metastases.
  • Have had certain treatments within 6-9 weeks before starting the study.
  • Have a specific gene mutation without prior treatment unless unable to tolerate it.
  • Have certain chronic viral infections unless well-controlled.
  • Have abnormal blood test results outside specified ranges.
  • Have a history of organ transplant.

Locations

FACILITYZIPCITYSTATE
Chao Family Comprehensive Cancer Center University of California, Irvine92868OrangeCalifornia

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