BMS-986012 in Relapsed/Refractory SCLC
Completed · Phase 1/Phase 2
Conditions studied: Small Cell Lung Cancer
In brief
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986012 alone and in combination with nivolumab in patients with relapsed/refractory SCLC.
Key facts
- Study ID
- NCT02247349
- Run by
- Bristol-Myers Squibb
- People needed
- 106
- Starts
- 2014-11-14
- Expected to finish
- 2022-12-22
- Last updated by the study team
- 2024-03-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histological or cytological confirmed small cell lung cancer (SCLC)
- Performance Status 0-1
- Adequate organ function
- Measurable disease
You may not qualify if…
- Known or suspected brain metastasis
- Small cell cancer not lung in origin
- Significant or acute medical illness
- Uncontrolled or significant cardiac disease
- Infection
- ≥ Grade 2 peripheral neuropathy
- Concomitant malignancies
- HIV related disease or known or suspected HIV+
- Hepatitis B or C infection
- ECG abnormalities as defined by the protocol
- Allergies or hypersensitivities to monoclonal antibodies, BMS-986012 or related compounds, including fucosyl-GM1 vaccine and Nivolumab
- Other protocol defined inclusion/exclusion criteria could apply
Where it is running
- Local Institution - 0004 — New York, New York, United States
- Local Institution - 0001 — Durham, North Carolina, United States
- Local Institution - 0021 — Winston-Salem, North Carolina, United States
- Local Institution - 0020 — St Leonards, New South Wales, Australia
- Local Institution - 0011 — Brisbane, Queensland, Australia
- Local Institution - 0002 — Clayton, Victoria, Australia
- Local Institution - 0015 — Ghent, Belgium
- Local Institution - 0012 — Liège, Belgium
- Local Institution - 0003 — Edmonton, Alberta, Canada
- Local Institution - 0017 — Halifax, Nova Scotia, Canada
- Local Institution - 0019 — Hamilton, Ontario, Canada
- Local Institution - 0010 — London, Ontario, Canada
- Local Institution - 0007 — Toronto, Ontario, Canada
- Local Institution - 0013 — Nijmegen, Netherlands
- Local Institution - 0009 — San Juan, Puerto Rico
- Local Institution - 0008 — Seoul, South Korea
Full record on ClinicalTrials.gov
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