A Study to Determine the Safety and Tolerability of BMS-986012 Alone and in Combination with Nivolumab in patients with Small Cell Lung Cancer

What we are studying

The purpose of this study is to find the highest tolerable dose of BMS-986012 that can be given to patients with relapsed (has come back) or refractory (has not responded to treatment) small cell lung cancer either alone or combined with an investigational drug called nivolumab. The study is also designed to find out what side effects these drugs have and whether they can shrink your cancer or keep it from growing. BMS-986012 is a monoclonal antibody that binds specifically to a component of the cell membrane called fucosyl-GM1. An antibody is a type of protein that your immune system (the system that defends your body against potentially harmful particles) uses to find and destroy foreign molecules (particles not typically found in your body such as bacteria and viruses). Scientists can now make antibodies in the laboratory and produce them for the treatment of many different diseases. Several antibodies for the treatment of various medical conditions including cancer have been approved by the FDA and other health authorities. Fucosyl-GM1 is found in small amounts, if any, in normal tissues but is present in most small cell lung cancers. Binding fucosyl-GM1 with BMS-986012 may help control this disease. BMS-986012 is an investigational drug that has not been approved by government agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This is the first study using BMS-986012 in humans. Nivolumab (Opdivo ™) has been approved by the FDA for the treatment of metastatic melanoma (a type of skin cancer) and a specific type of previously treated advanced lung cancer but not for small cell lung cancer. Nivolumab is an antibody that is being tested to see if it will allow the body’s immune system to work against tumor cells.

Who we are studying

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

Eligibility Criteria

  • Diagnosed with small cell lung cancer
  • Treated with one prior treatment
  • At least 4 weeks since last treatment
  • Adequate organ function
  • Ability to comply with visit schedule
  • Treatment schedule
  • Sample collection for laboratory tests
  • And treatment and follow-up
  • Cannot be pregnant or breastfeeding
  • Must agree to use adequate contraception
  • Cannot have past or active hepatitis B or C infection
  • Cannot have HIV
  • Cannot have any autoimmune diseases
  • Cannot have psychiatric or physical illness.

What is involved

  • Physical examinations
  • Vital signs
  • Medical history review
  • Pregnancy tests
  • Blood draws
  • CT/MRI scans
  • Safety assessments

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.