A study testing the effectiveness, safety and tolerability with increasing doses of study drug Varlilumab combined with Nivolumab in advanced cancer that does not respond to treatment.

What we are studying

You are being asked to participate in a research study of investigational drugs called varlilumab (also known as CDX-1127) and nivolumab (Opdivo®). This study will address the ongoing safety of the combination and also help determine how well the two drugs work together as an anti-cancer treatment. The study will be conducted at approximately 10-20 centers in the United States. Up to approximately 205 patients will be treated including 15 subjects at this research site. You can be in this study if you have been diagnosed with unresectable (i.e., surgery is not an option to adequately treat the tumor) or metastatic (i.e., cancer that has spread to other parts of the body) colorectal cancer, ovarian cancer, head and neck cancer, renal cell carcinoma and have received no more than five anti-cancer treatments for advanced disease or you have been diagnosed with glioblastoma, have been treated with temozolomide and radiation therapy, and now have a recurrence. Many of the procedures that will be performed during the study, including routine blood tests, urinalysis, tumor evaluations, physical examinations, electrocardiograms (ECGs: a measure of the electrical activity of your heart), vital signs (blood pressure, heart rate, breathing rate, and temperature) and measurement of height and weight, would normally be done as part of your standard care regardless of study participation. However, some of these may be done more frequently as a result of your participation in this study. If you have colorectal or renal cell cancer or glioblastoma you will receive varlilumab and nivolumab intravenously (into a vein, IV) every 2 weeks in the clinic. Varlilumab will be given to you as a 90 minute intravenous infusion. Following an approximately 30 minute break, nivolumab will be given to you as a 30 minute intravenous infusion. The study is divided up into periods of treatment and observation called Cycles, which are 8 weeks long. If you have head and neck or ovarian cancer, you will receive nivolumab intravenously (into a vein, IV) every two weeks. Depending on which treatment group you are assigned, varlilumab will be given to you either every 2 weeks, every 12 weeks, every 4 weeks as a 90 minute intravenous infusion depending on the treatment group you are assigned. Your study doctor will tell you what group you are assigned to. Your participation in this study is expected to last for up to approximately 3 years or longer. You will receive treatment until your disease worsens or if treatment causes you to experience side effects that are intolerable for you.

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

  • Must be able to Read/understood/provided written informed consent
  • No more than 5 prior anticancer treatments
  • Life expectancy ? 12 weeks
  • Can not be a women who is pregnant or lactating
  • Can not have an active infection requiring systemic therapy/known HIV infection/positive test for hepatitis B or hepatitis C

What is involved

  • Routine blood tests
  • Urinalysis
  • Tumor evaluations
  • Physical examinations
  • Medical history
  • Electrocardiograms (ECGs)
  • Vital signs
  • Measurement of height and weight
  • Biopsy of tumor tissue
  • Chest x-ray
  • CT or MRI scans of your chest/abdomen/and pelvis
  • Administration of study drug

Compensation

None

Contact Information

Study Coordinator
Christopher (Chase) Thurman
Email
[email protected]
Phone
-9010
Principal Investigator
Dr. Rhonda Bitting

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.