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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02247349




Registration number
NCT02247349
Ethics application status
Date submitted
19/09/2014
Date registered
25/09/2014
Date last updated
31/03/2020

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
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


Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety as measured by frequency of worst grade of adverse events (AEs), worst grade of serious adverse events (SAEs), incidence of adverse events leading to discontinuations, and deaths - Safety as measured by frequency of worst grade of adverse events (AEs), worst grade of serious adverse events (SAEs), incidence of adverse events leading to discontinuations, and deaths graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), as appropriate
Timepoint [1] 0 0
Weekly for 1st and 2nd 21-day cycles, then once every 3 weeks during study treatment, at end of treatment and every 30 days during clinical follow-up until resolution of adverse events or 100 days after the last dose of study medication (Approx 3 years)
Secondary outcome [1] 0 0
Maximum observed serum concentration (Cmax) for BMS-986012 (anti-fucosyl-GM1)
Timepoint [1] 0 0
At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
Secondary outcome [2] 0 0
Maximum observed serum concentration (Cmax) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab
Timepoint [2] 0 0
At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
Secondary outcome [3] 0 0
Time of maximum observed serum concentration (Tmax) for BMS-986012 (anti-fucosyl-GM1)
Timepoint [3] 0 0
At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
Secondary outcome [4] 0 0
Time of maximum observed serum concentration (Tmax) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab
Timepoint [4] 0 0
At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
Secondary outcome [5] 0 0
Observed serum concentration at the end of a dosing interval (Ctau) for BMS-986012 (anti-fucosyl-GM1)
Timepoint [5] 0 0
At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
Secondary outcome [6] 0 0
Observed serum concentration at the end of a dosing interval (Ctau) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab
Timepoint [6] 0 0
At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
Secondary outcome [7] 0 0
Area under the serum concentration-time curve from time zero to time t (AUC(0-t)) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab
Timepoint [7] 0 0
At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
Secondary outcome [8] 0 0
Area under the serum concentration-time curve from time zero to time t (AUC(0-t)) for BMS-986012 (anti-fucosyl-GM1)
Timepoint [8] 0 0
At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
Secondary outcome [9] 0 0
Area under the serum concentration-time curve in one dosing interval (AUC(TAU)) for BMS-986012 (anti-fucosyl-GM1)
Timepoint [9] 0 0
At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
Secondary outcome [10] 0 0
Area under the serum concentration-time curve in one dosing interval (AUC(TAU)) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab
Timepoint [10] 0 0
At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
Secondary outcome [11] 0 0
Best overall response (BOR) for BMS-986012 (anti-fucosyl-GM1) - Best overall response (BOR): defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy
Timepoint [11] 0 0
Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)
Secondary outcome [12] 0 0
Objective Response Rate (ORR) for BMS-986012 (anti-fucosyl-GM1) - Objective Response Rate (ORR): defined as the total number of subjects whose best overall response (BOR) is either a complete response (CR) or partial response (PR) divided by the total number of subjects in the population of interest
Timepoint [12] 0 0
Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)
Secondary outcome [13] 0 0
Duration of Response for BMS-986012 (anti-fucosyl-GM1) - Duration of Response: defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first
Timepoint [13] 0 0
Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)
Secondary outcome [14] 0 0
Progression Free Survival (PFS) for BMS-986012 (anti-fucosyl-GM1) - Progression Free Survival (PFS): defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause
Timepoint [14] 0 0
Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)
Secondary outcome [15] 0 0
Progression Free Survival Rate (PFSR) at week "t"; for BMS-986012 (anti-fucosyl-GM1) - Progression Free Survival Rate (PFSR) at week "t": defined as the proportion of subjects who remain progression free and surviving at "t" weeks (t=12, 24, 36, etc)
Timepoint [15] 0 0
Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)
Secondary outcome [16] 0 0
Overall Survival (OS) for BMS-986012 (anti-fucosyl-GM1) - Overall Survival (OS): defined as the time between the date of first dose of study medication and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive
Timepoint [16] 0 0
Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)
Secondary outcome [17] 0 0
Overall Survival Rate (OSR) at month "t" for BMS-986012 (anti-fucosyl-GM1) - Overall Survival Rate (OSR) at month "t": defined as the proportion of subjects surviving at "t" months (eg, t=6, 12, 24 months, etc)
Timepoint [17] 0 0
Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)
Secondary outcome [18] 0 0
Occurrence of specific anti-drug antibodies (ADA) to BMS-986012 every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up
Timepoint [18] 0 0
Every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
Secondary outcome [19] 0 0
Occurrence of specific anti-drug antibodies (ADA) to BMS-986012 in combination with Nivolumab every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up
Timepoint [19] 0 0
Every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
Secondary outcome [20] 0 0
Changes in the QTcF following administration of BMS-986012 at multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment
Timepoint [20] 0 0
At multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment (Approx duration of study 3 years)
Secondary outcome [21] 0 0
Changes in the QTcF following administration of BMS-986012 in combination with Nivolumab at multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment
Timepoint [21] 0 0
At multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment (Approx duration of study 3 years)

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
Gender
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/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - St. Leonards
Recruitment hospital [2] 0 0
Local Institution - Brisbane
Recruitment hospital [3] 0 0
Local Institution - 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
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.
Trial website
https://clinicaltrials.gov/show/NCT02247349
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

Summary results
Other publications