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Metronomic Cyclophosphamide with Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma

UCI Specialty Area: Cancer
Principal Investigator: Warren A Chow
Official Title: Metronomic Cyclophosphamide with Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma
A Study On:
Melanoma skin

Study Description

The purpose of this research study is to find out if the addition of oral cyclophosphamide to

intravenous pembrolizumab is able to improve the anti-tumor effect of pembrolizumab in patients

whose melanoma has continued to grow on checkpoint inhibitors alone.

Eligibility

Subjects can participate in this study if you satisfy the following criteria:

  • At least 18 years of age
  • Confirmed diagnosis of Stage III or Stage IV non-ocular (not related to eye or eyesight) melanoma that cannot be removed with surgery (unresectable)
  • Must have received pembrolizumab or a similar PD-1 therapy within 6 weeks (every 3 week dosing) or 9 weeks (every 6 week dosing) prior to the first dose of the investigational therapy
  • Individuals who can become pregnant or partners of individuals who can become pregnant must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study.

You cannot participate in this study if you have any of the following criteria:

  • Have an active HIV, hepatitis B or C infection
  • Are pregnant or nursing
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Interested in Participating in this Trial?

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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

  • Please read the information below and ask questions about anything that you do not understand. A
    researcher listed above will be available to answer your questions.
  • You are being asked to participate in a clinical research potential participant database to identify
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    at any time without penalty or loss of benefits. You are free to withdraw from this database at any
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    immediately    .
  • You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health
  • We would like to interview you to learn more about your eligibility for current clinical research studies at UCI. The interview will last about 5-30 minutes, depending on the extent of your medical history.
  • Possible risks/discomforts associated with the database are hearing about potential clinical research studies that may not be of interest to you, invasion of your privacy, or a potential breach of confidentiality.
  • There are no direct benefits from participation in the database. However, this database may help inform you on clinical research studies that you may be eligible for. Participation in UCI clinical research studies help us gain important data and knowledge that may lead to improved treatment options for people with similar conditions to you in the future.
  • There are no alternative procedures available. The only alternative is not to participate in this study.
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  • All information collected will be stored confidentially in a world-class securely-hosted application, “RealTime CTMS,” with robust data protections and encryption. This application has HIPAA compliant architecture and application rules to ensure data privacy and regulatory compliance.
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  • While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.
  • Future Research Use
    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
  • Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.
  • If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.
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  • Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at IRB@research.uci.edu or at 160 Aldrich Hall, Irvine, CA 92697-7600 if you are unable to reach the researchers listed at the top of the form and have general questions; have concerns or complaints about the research; have questions about your rights as a research subject; or have general comments or suggestions.

What is an IRB? An Institutional Review Board (IRB) is a committee made up of scientists and nonscientists. The IRB’s role is to protect the rights and welfare of human subjects involved in research. The IRB also assures that the research complies with applicable regulations, laws, and institutional policies.