Small Cell Lung CancerPhase 1/2NCT02247349
BMS-986012 in Relapsed/Refractory SCLC
A Phase 1/2 study testing BMS-986012 (anti-fucosyl-GM1) and Nivolumab in people with Small Cell Lung Cancer, run by Bristol-Myers Squibb at 16 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- BMS-986012 (anti-fucosyl-GM1) and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 16 sitesin 7 countries
- Study dates
- 14 Nov 2014to 22 Dec 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological confirmed small cell lung cancer (SCLC)
- Performance Status 0-1
- Adequate organ function
- Measurable disease
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
Canada5 sites
Local Institution - 0003
Edmonton, Alberta, T6G 1Z2
Local Institution - 0017
Halifax, Nova Scotia, B3H 2Y9
Local Institution - 0019
Hamilton, Ontario, L8V 5C2
Local Institution - 0010
London, Ontario, N6A 4L6
Local Institution - 0007
Toronto, Ontario, M5G 2M9
United States3 sites
Local Institution - 0001
Durham, North Carolina, 27710
Local Institution - 0004
New York, New York, 10065
Local Institution - 0021
Winston-Salem, North Carolina, 27157
Australia3 sites
Local Institution - 0011
Brisbane, Queensland, 4102
Local Institution - 0002
Clayton, Victoria, 3168
Local Institution - 0020
St Leonards, New South Wales, 2065
Belgium2 sites
Local Institution - 0015
Ghent, 9000
Local Institution - 0012
Liège, 4000
About this study
Official title: A Phase 1/2 Multicenter Study of BMS-986012 in Subjects With Relapsed/Refractory Small Cell Lung Cancer
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.
- Conditions
- Small Cell Lung Cancer
- Being tested
- BMS-986012 (anti-fucosyl-GM1), Nivolumab
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986012 (anti-fucosyl-GM1)Biological
NivolumabBiological
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation (Monotherapy) Dose -1 | Experimental | BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity Receives: Biological: BMS-986012 (anti-fucosyl-GM1) |
| Dose Escalation (Monotherapy) Dose 1 | Experimental | BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity Receives: Biological: BMS-986012 (anti-fucosyl-GM1) |
| Dose Escalation (Monotherapy) Dose 2 | Experimental | BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity Receives: Biological: BMS-986012 (anti-fucosyl-GM1) |
| Dose Escalation (Monotherapy) Dose 3 | Experimental | BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity Receives: Biological: BMS-986012 (anti-fucosyl-GM1) |
| Dose Escalation (Monotherapy) Dose 4 | Experimental | BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity Receives: Biological: BMS-986012 (anti-fucosyl-GM1) |
| Dose Expansion (Monotherapy)- Cohort A (Refractory) | Experimental | BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity Receives: Biological: BMS-986012 (anti-fucosyl-GM1) |
| Dose Expansion (Monotherapy) Cohort B (Refractory) | Experimental | BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity Receives: Biological: BMS-986012 (anti-fucosyl-GM1) |
| Dose Expansion (Monotherapy) Cohort C (Sensitive) | Experimental | BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity Receives: Biological: BMS-986012 (anti-fucosyl-GM1) |
| Dose Expansion (Monotherapy) Cohort D (Sensitive) | Experimental | BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity Receives: Biological: BMS-986012 (anti-fucosyl-GM1) |
| Dose Escalation (Combination) Dose 1 | Experimental | 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 Receives: Biological: BMS-986012 (anti-fucosyl-GM1); Biological: Nivolumab |
| Dose Escalation (Combination) Dose 2 | Experimental | 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 Receives: Biological: BMS-986012 (anti-fucosyl-GM1); Biological: Nivolumab |
| Dose Expansion (Combination)- (Refractory and Sensitive) | Experimental | 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 Receives: Biological: BMS-986012 (anti-fucosyl-GM1); Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
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.
Measured: From first dose to 100 days post last dose (Up to 64 months)
Number of Participants With Serious Adverse Events (SAEs)
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.
Measured: From first dose to 100 days post last dose (Up to 64 months)
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
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.
Measured: From first dose to 100 days post last dose (Up to 64 months)
Number of Participants Who Died
Number of participants who died due to any cause.
Measured: From first dose to 100 days post last dose (Up to 64 months)
Number of Participants With Abnormal Hepatic Test
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
Measured: From first dose to 100 days post last dose (Up to 64 months)
Secondary outcomes (18)
BMS-986012 Maximum Observed Serum Concentration (Cmax)
BMS-986012 maximum observed serum concentration (Cmax).
Measured: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Time of Maximum Observed Serum Concentration (Tmax)
BMS-986012 time of maximum observed serum concentration (Tmax).
Measured: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))
BMS-986012 area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)).
Measured: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)
BMS-986012 area under the serum concentration-time curve in one dosing interval AUC (TAU).
Measured: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Observed Serum Concentration at the End of a Dosing Interval (Ctau)
BMS-986012 observed serum concentration at the end of a dosing interval (Ctau).
Measured: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Total Body Clearance (CLT)
BMS-986012 total body clearance (CLT).
Measured: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Trough Observed Serum Concentration (Ctrough)
BMS-986012 trough observed serum concentration (Ctrough).
Measured: 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)
BMS-986012 Average Concentration Over a Dosing Interval (Css-avg)
BMS-986012 Average concentration over a dosing interval ([AUC(TAU)/tau] (Css-avg).
Measured: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Accumulation Index (AI_AUC)
BMS-986012 accumulation index. Ratio of an exposure measure at steady state to that after the first dose.
Measured: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Cmax Accumulation Index (AI_Cmax)
BMS-986012 Cmax accumulation index (AI_Cmax). Ratio of an exposure measure at steady state to that after the first dose.
Measured: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Ctau Accumulation Index (AI_Ctau)
BMS-986012 Ctau accumulation index (AI_Ctau). Ratio of an exposure measure at steady state to that after the first dose.
Measured: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Effective Elimination (T-HALFeff)
BMS-986012 effective elimination (T-HALFeff) that explains the degree of accumulation observed for a specific exposure measure.
Measured: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
Best Overall Response (BOR)
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
Measured: From first dose to the last tumor assessment prior to subsequent therapy (Up to 97 months)
Objective Response Rate (ORR)
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
Measured: From first dose date to the date of first documented disease progression (Up to 97 months)
Duration of Response (DoR)
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.
Measured: 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)
Progression Free Survival (PFS)
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
Measured: 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)
Progression Free Survival Rate (PFSR)
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
Measured: Weeks 12, 24, 36, 48, 60, 72
Number of Participants With Anti-BMS-986012 Antibodies (ADA)
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.
Measured: From first dose to 100 days following the last BMS-986012 dose (Up to 64 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study start14 Nov 2014
- Primary completion21 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247349
- Sponsor's protocol ID
- CA001-030
- Other IDs
- 2014-002372-89, 2014
- Status last verified
- Feb 2024
- First submitted
- 19 Sep 2014
- Last updated
- 5 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Multicenter Study of BMS-986012 in Subjects With Relapsed/Refractory Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02247349
- Acronym / sponsor ID
- CA001-030
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2014 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Posted 5 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation (Monotherapy) Dose -1 | Experimental | Biological: BMS-986012 (anti-fucosyl-GM1)BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity |
| Dose Escalation (Monotherapy) Dose 1 | Experimental | Biological: BMS-986012 (anti-fucosyl-GM1)BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity |
| Dose Escalation (Monotherapy) Dose 2 | Experimental | Biological: BMS-986012 (anti-fucosyl-GM1)BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity |
| Dose Escalation (Monotherapy) Dose 3 | Experimental | Biological: BMS-986012 (anti-fucosyl-GM1)BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity |
| Dose Escalation (Monotherapy) Dose 4 | Experimental | Biological: BMS-986012 (anti-fucosyl-GM1)BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity |
| Dose Expansion (Monotherapy)- Cohort A (Refractory) | Experimental | Biological: BMS-986012 (anti-fucosyl-GM1)BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity |
| Dose Expansion (Monotherapy) Cohort B (Refractory) | Experimental | Biological: BMS-986012 (anti-fucosyl-GM1)BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity |
| Dose Expansion (Monotherapy) Cohort C (Sensitive) | Experimental | Biological: BMS-986012 (anti-fucosyl-GM1)BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity |
| Dose Expansion (Monotherapy) Cohort D (Sensitive) | Experimental | Biological: BMS-986012 (anti-fucosyl-GM1)BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity |
| Dose Escalation (Combination) Dose 1 | Experimental | Biological: BMS-986012 (anti-fucosyl-GM1), Biological: NivolumabBMS-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 |
| Dose Escalation (Combination) Dose 2 | Experimental | Biological: BMS-986012 (anti-fucosyl-GM1), Biological: NivolumabBMS-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 |
| Dose Expansion (Combination)- (Refractory and Sensitive) | Experimental | Biological: BMS-986012 (anti-fucosyl-GM1), Biological: NivolumabBMS-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histological or cytological confirmed small cell lung cancer (SCLC)
- Performance Status 0-1
- Adequate organ function
- Measurable disease
Key exclusion criteria (12 listed)
- Known or suspected brain metastasis
- Small cell cancer not lung in origin
- Significant or acute medical illness
- Uncontrolled or significant cardiac disease
- Infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986012 (anti-fucosyl-GM1) | Biological | Dose Escalation (Combination) Dose 1, Dose Escalation (Combination) Dose 2, Dose Escalation (Monotherapy) Dose -1, Dose Escalation (Monotherapy) Dose 1, Dose Escalation (Monotherapy) Dose 2, Dose Escalation (Monotherapy) Dose 3, Dose Escalation (Monotherapy) Dose 4, Dose Expansion (Combination)- (Refractory and Sensitive), Dose Expansion (Monotherapy) Cohort B (Refractory), Dose Expansion (Monotherapy) Cohort C (Sensitive), Dose Expansion (Monotherapy) Cohort D (Sensitive), Dose Expansion (Monotherapy)- Cohort A (Refractory) |
| Nivolumab | Biological | Dose Escalation (Combination) Dose 1, Dose Escalation (Combination) Dose 2, Dose Expansion (Combination)- (Refractory and Sensitive) |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: From first dose to 100 days post last dose (Up to 64 months)
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.
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From first dose to 100 days post last dose (Up to 64 months)
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.
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
Time frame: From first dose to 100 days post last dose (Up to 64 months)
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.
Number of Participants Who Died
Time frame: From first dose to 100 days post last dose (Up to 64 months)
Number of participants who died due to any cause.
Number of Participants With Abnormal Hepatic Test
Time frame: From first dose to 100 days post last dose (Up to 64 months)
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
18 secondary outcomes
BMS-986012 Maximum Observed Serum Concentration (Cmax)
Time frame: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Time of Maximum Observed Serum Concentration (Tmax)
Time frame: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))
Time frame: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)
Time frame: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Observed Serum Concentration at the End of a Dosing Interval (Ctau)
Time frame: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Total Body Clearance (CLT)
Time frame: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Trough Observed Serum Concentration (Ctrough)
Time frame: 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)
BMS-986012 Average Concentration Over a Dosing Interval (Css-avg)
Time frame: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Accumulation Index (AI_AUC)
Time frame: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Cmax Accumulation Index (AI_Cmax)
Time frame: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Ctau Accumulation Index (AI_Ctau)
Time frame: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Effective Elimination (T-HALFeff)
Time frame: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
Best Overall Response (BOR)
Time frame: From first dose to the last tumor assessment prior to subsequent therapy (Up to 97 months)
Objective Response Rate (ORR)
Time frame: From first dose date to the date of first documented disease progression (Up to 97 months)
Duration of Response (DoR)
Time frame: 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)
Progression Free Survival (PFS)
Time frame: 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)
Progression Free Survival Rate (PFSR)
Time frame: Weeks 12, 24, 36, 48, 60, 72
Number of Participants With Anti-BMS-986012 Antibodies (ADA)
Time frame: From first dose to 100 days following the last BMS-986012 dose (Up to 64 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMS-986012 (anti-fucosyl-GM1) and Nivolumab in people with Small Cell Lung Cancer, run by Bristol-Myers Squibb at 16 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Canada, United States, Australia, Belgium, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) (time frame: From first dose to 100 days post last dose (Up to 64 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.