Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
106 participants
INTERVENTIONAL
2014-11-14
2022-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose Escalation (Monotherapy) Dose -1
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
BMS-986012 (anti-fucosyl-GM1)
Dose Escalation (Monotherapy) Dose 1
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
BMS-986012 (anti-fucosyl-GM1)
Dose Escalation (Monotherapy) Dose 2
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
BMS-986012 (anti-fucosyl-GM1)
Dose Escalation (Monotherapy) Dose 3
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
BMS-986012 (anti-fucosyl-GM1)
Dose Escalation (Monotherapy) Dose 4
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
BMS-986012 (anti-fucosyl-GM1)
Dose Expansion (Monotherapy)- Cohort A (Refractory)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
BMS-986012 (anti-fucosyl-GM1)
Dose Expansion (Monotherapy) Cohort B (Refractory)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
BMS-986012 (anti-fucosyl-GM1)
Dose Expansion (Monotherapy) Cohort C (Sensitive)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
BMS-986012 (anti-fucosyl-GM1)
Dose Expansion (Monotherapy) Cohort D (Sensitive)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
BMS-986012 (anti-fucosyl-GM1)
Dose Escalation (Combination) Dose 1
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity in combination with Nivolumab specified dose on specified days
BMS-986012 (anti-fucosyl-GM1)
Nivolumab
Dose Escalation (Combination) Dose 2
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity in combination with Nivolumab specified dose on specified days
BMS-986012 (anti-fucosyl-GM1)
Nivolumab
Dose Expansion (Combination)- (Refractory and Sensitive)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity in combination with Nivolumab specified dose on specified days
BMS-986012 (anti-fucosyl-GM1)
Nivolumab
Interventions
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BMS-986012 (anti-fucosyl-GM1)
Nivolumab
Eligibility Criteria
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Inclusion Criteria
* Performance Status 0-1
* Adequate organ function
* Measurable disease
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2014-002372-89
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA001-030
Identifier Type: -
Identifier Source: org_study_id
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