A Study to Determine the Safety of Nivolumab with Ipilimumab in Subject with Advanced Cancers

What we are studying

The purpose of this study is to test the safety, tolerability and effectiveness (how well the drug works), of the combination of two investigational drugs called nivolumab and ipilimumab in subjects with non-small cell lung cancer (NSCLC). Nivolumab and ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab (Opdivo ™) has been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of metastatic melanoma (a type of skin cancer), and specific types of previously treated advanced lung and kidney cancers. Ipilimumab (Yervoy™) is approved by the FDA, EMA and other health authorities for the treatment of metastatic melanoma. The effectiveness will be determined by seeing if treatment with nivolumab and ipilimumab increases the chance you will have a positive response, improves your chances of survival and delays the worsening of your cancer (called progression).

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • You must be able to sign and date a written consent form
  • Must have evaluable disease by imaging scans
  • You must have tumor tissue or be willing to give tumor tissue for PD-L1 testing
  • Women of childbearing potential must use birth control according to the protocol
  • Men who are sexually active must use contraception according to the protocol
  • Cannot donate sperm or eggs

What is involved

  • Medical history review
  • Physical examination
  • Vital signs
  • Pregnancy tests
  • Laboratory tests
  • ECG
  • Tumor assessments
  • Collection of archived tumor or recent tumor biopsy
  • Questionnaires
  • Blood draws
  • CT/MRI scans

Compensation

None

Contact Information

Study Coordinator
Sharon Averill, RN, CCRP
Email
saverill@wakehealth.edu
Phone
336-713-7748
Principal Investigator
Stefan Grant, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.