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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Phase 1/2 Multicenter Study of BMS-986012 in Subjects With Relapsed/Refractory Small Cell Lung Cancer
Secondary ID [1] 0 0
2014-002372-89
Secondary ID [2] 0 0
CA001-030
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
From first dose to 100 days post last dose (Up to 64 months)
Primary outcome [2] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [2] 0 0
From first dose to 100 days post last dose (Up to 64 months)
Primary outcome [3] 0 0
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
Timepoint [3] 0 0
From first dose to 100 days post last dose (Up to 64 months)
Primary outcome [4] 0 0
Number of Participants Who Died
Timepoint [4] 0 0
From first dose to 100 days post last dose (Up to 64 months)
Primary outcome [5] 0 0
Number of Participants With Abnormal Hepatic Test
Timepoint [5] 0 0
From first dose to 100 days post last dose (Up to 64 months)
Secondary outcome [1] 0 0
BMS-986012 Maximum Observed Serum Concentration (Cmax)
Timepoint [1] 0 0
Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
Secondary outcome [2] 0 0
BMS-986012 Time of Maximum Observed Serum Concentration (Tmax)
Timepoint [2] 0 0
Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
Secondary outcome [3] 0 0
BMS-986012 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))
Timepoint [3] 0 0
Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
Secondary outcome [4] 0 0
BMS-986012 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)
Timepoint [4] 0 0
Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
Secondary outcome [5] 0 0
BMS-986012 Observed Serum Concentration at the End of a Dosing Interval (Ctau)
Timepoint [5] 0 0
Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
Secondary outcome [6] 0 0
BMS-986012 Total Body Clearance (CLT)
Timepoint [6] 0 0
Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
Secondary outcome [7] 0 0
BMS-986012 Trough Observed Serum Concentration (Ctrough)
Timepoint [7] 0 0
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)
Secondary outcome [8] 0 0
BMS-986012 Average Concentration Over a Dosing Interval (Css-avg)
Timepoint [8] 0 0
Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
Secondary outcome [9] 0 0
BMS-986012 Accumulation Index (AI_AUC)
Timepoint [9] 0 0
Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
Secondary outcome [10] 0 0
BMS-986012 Cmax Accumulation Index (AI_Cmax)
Timepoint [10] 0 0
Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
Secondary outcome [11] 0 0
BMS-986012 Ctau Accumulation Index (AI_Ctau)
Timepoint [11] 0 0
Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
Secondary outcome [12] 0 0
BMS-986012 Effective Elimination (T-HALFeff)
Timepoint [12] 0 0
Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
Secondary outcome [13] 0 0
Best Overall Response (BOR)
Timepoint [13] 0 0
From first dose to the last tumor assessment prior to subsequent therapy (Up to 97 months)
Secondary outcome [14] 0 0
Objective Response Rate (ORR)
Timepoint [14] 0 0
From first dose date to the date of first documented disease progression (Up to 97 months)
Secondary outcome [15] 0 0
Duration of Response (DoR)
Timepoint [15] 0 0
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)
Secondary outcome [16] 0 0
Progression Free Survival (PFS)
Timepoint [16] 0 0
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)
Secondary outcome [17] 0 0
Progression Free Survival Rate (PFSR)
Timepoint [17] 0 0
Weeks 12, 24, 36, 48, 60, 72
Secondary outcome [18] 0 0
Number of Participants With Anti-BMS-986012 Antibodies (ADA)
Timepoint [18] 0 0
From first dose to 100 days following the last BMS-986012 dose (Up to 64 months)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/12/2022
Sample size
Target
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - 0020 - St. Leonards
Recruitment hospital [2] 0 0
Local Institution - 0011 - Brisbane
Recruitment hospital [3] 0 0
Local Institution - 0002 - Clayton
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
Belgium
State/province [3] 0 0
Gent
Country [4] 0 0
Belgium
State/province [4] 0 0
Liege
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Canada
State/province [6] 0 0
Nova Scotia
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seoul
Country [9] 0 0
Netherlands
State/province [9] 0 0
Nijmegen
Country [10] 0 0
Puerto Rico
State/province [10] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02247349