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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02247349
Registration number
NCT02247349
Ethics application status
Date submitted
19/09/2014
Date registered
25/09/2014
Date last updated
5/03/2024
Titles & IDs
Public title
BMS-986012 in Relapsed/Refractory SCLC
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Scientific title
A Phase 1/2 Multicenter Study of BMS-986012 in Subjects With Relapsed/Refractory Small Cell Lung Cancer
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Secondary ID [1]
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2014-002372-89
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Secondary ID [2]
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CA001-030
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - BMS-986012 (anti-fucosyl-GM1)
Other interventions - Nivolumab
Experimental: Dose Escalation (Monotherapy) Dose -1 - BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Experimental: Dose Escalation (Monotherapy) Dose 1 - BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Experimental: Dose Escalation (Monotherapy) Dose 2 - BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Experimental: Dose Escalation (Monotherapy) Dose 3 - BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Experimental: Dose Escalation (Monotherapy) Dose 4 - BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Other interventions: BMS-986012 (anti-fucosyl-GM1)
Other interventions: Nivolumab
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Adverse Events (AEs)
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Assessment method [1]
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Number of participants with any grade adverse events (AEs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
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Timepoint [1]
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From first dose to 100 days post last dose (Up to 64 months)
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Primary outcome [2]
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Number of Participants With Serious Adverse Events (SAEs)
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Assessment method [2]
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Number of participants with any grade serious adverse events (SAEs). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
results in death
is life-threatening
requires inpatient hospitalization or causes prolongation of existing hospitalization
results in persistent or significant disability/incapacity
is a congenital anomaly/birth defect
is an important medical event Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
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Timepoint [2]
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From first dose to 100 days post last dose (Up to 64 months)
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Primary outcome [3]
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Number of Participants With Adverse Events (AEs) Leading to Discontinuation
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Assessment method [3]
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Number of participants with any grade adverse events (AEs) leading to discontinuation. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
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Timepoint [3]
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From first dose to 100 days post last dose (Up to 64 months)
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Primary outcome [4]
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Number of Participants Who Died
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Assessment method [4]
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Number of participants who died due to any cause.
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Timepoint [4]
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From first dose to 100 days post last dose (Up to 64 months)
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Primary outcome [5]
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Number of Participants With Abnormal Hepatic Test
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Assessment method [5]
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Number of participants with laboratory abnormalities in specific hepatic tests. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:
ALT or AST > 5xULN, > 3xULN, and > 2xULN
Any of ALT, AST, Total Bilirubin or ALP > 8xULN
Total bilirubin > 3xULN
ALT = Alanine Aminotransferase; AST = Aspartate Aminotransferase; ULN = Upper Limit of Normal
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Timepoint [5]
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From first dose to 100 days post last dose (Up to 64 months)
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Secondary outcome [1]
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BMS-986012 Maximum Observed Serum Concentration (Cmax)
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Assessment method [1]
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BMS-986012 maximum observed serum concentration (Cmax).
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Timepoint [1]
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Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
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Secondary outcome [2]
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BMS-986012 Time of Maximum Observed Serum Concentration (Tmax)
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Assessment method [2]
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BMS-986012 time of maximum observed serum concentration (Tmax).
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Timepoint [2]
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Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
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Secondary outcome [3]
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BMS-986012 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))
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Assessment method [3]
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BMS-986012 area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)).
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Timepoint [3]
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Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
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Secondary outcome [4]
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BMS-986012 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)
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Assessment method [4]
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BMS-986012 area under the serum concentration-time curve in one dosing interval AUC (TAU).
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Timepoint [4]
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Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
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Secondary outcome [5]
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BMS-986012 Observed Serum Concentration at the End of a Dosing Interval (Ctau)
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Assessment method [5]
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BMS-986012 observed serum concentration at the end of a dosing interval (Ctau).
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Timepoint [5]
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Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
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Secondary outcome [6]
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BMS-986012 Total Body Clearance (CLT)
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Assessment method [6]
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BMS-986012 total body clearance (CLT).
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Timepoint [6]
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Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
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Secondary outcome [7]
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BMS-986012 Trough Observed Serum Concentration (Ctrough)
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Assessment method [7]
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BMS-986012 trough observed serum concentration (Ctrough).
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Timepoint [7]
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Cycle 2 day 1, cycle 3 day 1, cycle 4 day 1, cycle 7 day 1, cycle 11 day 1. cycle 15 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
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Secondary outcome [8]
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BMS-986012 Average Concentration Over a Dosing Interval (Css-avg)
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Assessment method [8]
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BMS-986012 Average concentration over a dosing interval ([AUC(TAU)/tau] (Css-avg).
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Timepoint [8]
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Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
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Secondary outcome [9]
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BMS-986012 Accumulation Index (AI_AUC)
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Assessment method [9]
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BMS-986012 accumulation index. Ratio of an exposure measure at steady state to that after the first dose.
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Timepoint [9]
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Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
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Secondary outcome [10]
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BMS-986012 Cmax Accumulation Index (AI_Cmax)
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Assessment method [10]
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BMS-986012 Cmax accumulation index (AI_Cmax). Ratio of an exposure measure at steady state to that after the first dose.
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Timepoint [10]
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Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
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Secondary outcome [11]
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BMS-986012 Ctau Accumulation Index (AI_Ctau)
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Assessment method [11]
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BMS-986012 Ctau accumulation index (AI_Ctau). Ratio of an exposure measure at steady state to that after the first dose.
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Timepoint [11]
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Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
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Secondary outcome [12]
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BMS-986012 Effective Elimination (T-HALFeff)
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Assessment method [12]
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BMS-986012 effective elimination (T-HALFeff) that explains the degree of accumulation observed for a specific exposure measure.
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Timepoint [12]
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Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
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Secondary outcome [13]
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Best Overall Response (BOR)
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Assessment method [13]
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BOR defined as the best response designation over the study as a whole. Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = At least a 30% decrease in the sum of diameters of target lesions; Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm
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Timepoint [13]
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From first dose to the last tumor assessment prior to subsequent therapy (Up to 97 months)
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Secondary outcome [14]
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Objective Response Rate (ORR)
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Assessment method [14]
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ORR is defined as the percent of participants whose BOR is either CR or PR. Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = At least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm
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Timepoint [14]
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From first dose date to the date of first documented disease progression (Up to 97 months)
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Secondary outcome [15]
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Duration of Response (DoR)
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Assessment method [15]
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DoR is defined as the time from first response (CR or PR) to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who remain alive and have not progressed will be censored on the date of their last tumor assessment.
Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR )= At least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm
Median DOR will only be evaluated provided there are enough responding participants to warrant inclusion.
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Timepoint [15]
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From the date of first dose to the date of the first documented tumor progression or death due to any cause, whichever occurs first (Up to 97 months)
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Secondary outcome [16]
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Progression Free Survival (PFS)
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Assessment method [16]
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PFS is defined as the time from the date of first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause, if death occurred within 100 days after last BMS-986012 dose.
Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm
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Timepoint [16]
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From first dose to the date of first documented disease progression or death due to any cause, if death occurred within 100 days after last BMS-986012 dose (Up to 97 months)
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Secondary outcome [17]
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Progression Free Survival Rate (PFSR)
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Assessment method [17]
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PFSR is defined as the percent of participants who remain progression free and surviving at "t" weeks (t= 12, 24, 36, 48, 60, 72).
Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm
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Timepoint [17]
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Weeks 12, 24, 36, 48, 60, 72
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Secondary outcome [18]
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Number of Participants With Anti-BMS-986012 Antibodies (ADA)
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Assessment method [18]
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Number of participants with anti-BMS-986012 antibodies (ADA) with status as baseline ADA positive, ADA positive and ADA negative. Baseline ADA positive participant is a participant with baseline ADA positive sample (Day 1 predose). ADA-positive participant is a participant with at least one ADA positive sample relative to baseline at any time after initiation of treatment during the defined observation time period. ADA negative participant is a participant with no ADA positive sample after the initiation of treatment.
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Timepoint [18]
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From first dose to 100 days following the last BMS-986012 dose (Up to 64 months)
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Eligibility
Key inclusion criteria
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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/11/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
22/12/2022
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Sample size
Target
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Accrual to date
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Final
106
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Local Institution - 0020 - St. Leonards
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Recruitment hospital [2]
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Local Institution - 0011 - Brisbane
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Recruitment hospital [3]
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Local Institution - 0002 - Clayton
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Recruitment postcode(s) [1]
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2065 - St. Leonards
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Recruitment postcode(s) [2]
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4102 - Brisbane
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New York
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Country [2]
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United States of America
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State/province [2]
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North Carolina
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Country [3]
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Belgium
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State/province [3]
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Gent
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Country [4]
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Belgium
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State/province [4]
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Liege
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Country [5]
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Canada
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State/province [5]
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Alberta
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Country [6]
0
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Canada
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State/province [6]
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Nova Scotia
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Country [7]
0
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Canada
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State/province [7]
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Ontario
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Country [8]
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0
Korea, Republic of
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State/province [8]
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Seoul
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Country [9]
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Netherlands
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State/province [9]
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Nijmegen
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Country [10]
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Puerto Rico
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State/province [10]
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San Juan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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 patients with relapsed/refractory SCLC.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02247349
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02247349
Download to PDF