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[Expanded Access] An Open-label, Multi-center, Single Arm, Rollover Study of GME751 (Proposed Pembrolizumab Biosimilar) in Participants Who Are Eligible for Continued Pembrolizumab Treatment After Participation in CGME751A12101 or CGME751A12301 Studies

UCI Specialty Area: Cancer
Principal Investigator: Warren A Chow
A Study On:
Melanoma skin

Study Description

The purpose of this study is to provide continued access to GME751 (a proposed pembrolizumab biosimilar, meaning a similar version) treatment in accordance with the recommended therapy duration of pembrolizumab, and to evaluate the safety of continued exposure to GME751 of participants who derived benefit from pembrolizumab while enrolled in one of the two studies: Study CGME751A12101 (hereafter, Study 101) in participants with completely resected melanoma requiring adjuvant treatment (treatment given in addition to chemotherapy/surgery to reduce the chances of the cancer coming back) or in Study CGME751A12301 (hereafter, Study 301) in participants with metastatic non-small cell lung cancer (NSCLC).

Eligibility

  1. Previous subjects of either Study 101 or Study 301 who are judged by Investigator to benefit from continued treatment with pembrolizumab
  2. Previous subjects who've demonstrated compliance with Study 101 or Study 301 protocol requirements as assessed by Investigator
  3. Subjects who've completed Study 101 or Study 301 as per protocol OR discontinued treatment and consequently participation in either Study 101 or Study 301
  4. Subjects who discontinued from Study 301 based on Sponsor decision to terminate Study 301

Key

  1. Subjects who experienced disease recurrence in either Study 101 or Study 301, OR disease progression in ONLY Study 301
  2. Subjects who experienced unacceptable toxicity related to pembrolizumab during either Study 101 or Study 301
  3. Subjects who used other investigational drugs after completion or discontinuation of Study 101 or Study 301
  4. Subjects who've had surgery with inadequate internal/external wound recovery within 3 weeks of administration of 1st dose of study intervention
  5. Previously reported hypersensitivity to any recombinant protein drugs, pemetrexed, or any mediums of administration used in this study's investigational drug and pemetrexed
  6. Clinically significant active infections requiring systemic therapy (per Investigator's discretion) that may increase the risk associated with study participation
  7. History or current diagnosis of cardiac disease that may increase the risk associated with study participation, per Investigator's assessment.
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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
    potential clinical research studies you may be eligible for. Participation in this database is voluntary.
    You may choose to skip any question. You may refuse to participate or discontinue your involvement
    at any time without penalty or loss of benefits. You are free to withdraw from this database at any
    time. If you decide to withdraw from this database you should notify the research team
    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.
  • There is no compensation for your participation in this database.
  • There is no cost to you for participation in this database.
  • 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.
  • Researchers will use your information to assess your eligibility for current and future clinical research studies at UCI. You may opt out at any time.
  • The research team, authorized UCI personnel, and regulatory entities, may have access to your study records to protect your safety and welfare.
  • 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.
  • If you have any comments, concerns, or questions regarding the conduct of this research please contact the researchers listed at the top of this form
  • 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. UCI