Status:
COMPLETED
BMS-986012 in Relapsed/Refractory SCLC
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 p...
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- Histological or cytological confirmed small cell lung cancer (SCLC)
- Performance Status 0-1
- Adequate organ function
- Measurable disease
Exclusion
- 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
Key Trial Info
Start Date :
November 14 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2022
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT02247349
Start Date
November 14 2014
End Date
December 22 2022
Last Update
March 5 2024
Active Locations (16)
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1
Local Institution - 0004
New York, New York, United States, 10065
2
Local Institution - 0001
Durham, North Carolina, United States, 27710
3
Local Institution - 0021
Winston-Salem, North Carolina, United States, 27157
4
Local Institution - 0020
St Leonards, New South Wales, Australia, 2065