Back to resultsA Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer
Primary Purpose
Extensive-stage Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-986012
Carboplatin
Etoposide
Nivolumab
Sponsored by
About this trial
This is an interventional treatment trial for Extensive-stage Small Cell Lung Cancer focused on measuring BMS-986012, Carboplatin, Etoposide, Extensive-stage small cell lung cancer, Fucosyl, Nivolumab, Targeted SCLC therapy
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC) and extensive-stage disease (American Joint Committee on Cancer, 8th edition, Stage IV [T any, N any, M1a, M1b, or M1c], or T3-4 due to multiple lung nodules that are too extensive or tumor or nodal volume that is too large to be encompassed in a tolerable radiation plan)
- Participants taking part in the separate PET tracer sub-study must provide a fresh tumor biopsy from any disease site (primary or metastatic)
- Archived tumor specimens, in the form of blocks or sectioned slides, are mandatory for all participants except those participating in the separate PET tracer sub-study for whom the archived tumor specimen is optional
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
- At least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria
- Adequate hematologic and end organ function
- Must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
- Women who are pregnant or breastfeeding. Japan only: participation in the study is not allowed even if breastfeeding is suspended
- Prior chemotherapy, radiation therapy, or biologic therapy for SCLC. Previously treated limited stage SCLC (LS-SCLC) participants are also excluded
- Symptomatic brain or other central nervous system (CNS) metastases
- Paraneoplastic autoimmune syndrome requiring systemic treatment
- History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan
- Grade ≥ 2 peripheral sensory neuropathy at study entry
- Significant uncontrolled cardiovascular disease
- Active, known or suspected autoimmune disease or inflammatory disorder
Other protocol-defined inclusion/exclusion criteria apply
Sites / Locations
- Local Institution - 0075
- Local Institution
- Local Institution - 0022
- Local Institution - 0002
- Local Institution - 0060
- Local Institution
- Local Institution - 0067
- Local Institution - 0081
- Local Institution
- Local Institution - 0003
- Local Institution - 0023
- Local Institution - 0078
- Local Institution - 0001
- Local Institution - 0004
- Local Institution - 0051Recruiting
- Local Institution - 0034Recruiting
- Local Institution - 0050Recruiting
- Local Institution - 0012
- Local Institution - 0064
- Local Institution - 0045
- Local Institution - 0036
- Local Institution - 0038
- Casa di Cura Dott. Pederzoli
- Local Institution - 0031
- Humanitas-U.O di Oncologia medica ed Ematologia
- Local Institution - 0073
- Local Institution - 0070
- Local Institution - 0069
- Local Institution - 0077
- Local Institution - 0039Recruiting
- Local Institution - 0066Recruiting
- Local Institution - 0040Recruiting
- Local Institution - 0079
- Local Institution
- Local Institution - 0049
- Local Institution - 0048
- Local Institution - 0043
- Local Institution - 0042
- Local Institution - 0041
- Local Institution - 0007
- Local Institution - 0021
- Local Institution - 0005
- Local Institution - 0006
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012
Arm B: Carboplatin + Etoposide + Nivolumab
Arm Description
Outcomes
Primary Outcome Measures
Incidence of adverse events (AEs)
Incidence of serious adverse events (SAEs)
Incidence of AEs leading to discontinuation
Incidence of deaths
Progression-free survival (PFS) by blinded independent central review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Secondary Outcome Measures
Progression-free survival rate (PFSR)
PFS by BICR based on RECIST v1.1 criteria
PFS by investigator based on RECIST v1.1 criteria
PFSR
PFS by investigator based on RECIST v1.1 criteria
Objective response rate (ORR) based on RECIST v1.1 criteria
Time to response (TTR) based on RECIST v1.1 criteria
Duration of response (DOR) based on RECIST v1.1 criteria
Overall survival (OS)
By arm
Overall survival rate (OSR)
By arm
Immunogenicity of BMS-986012 measured by assessment of the presence of specific anti-drug antibodies (ADAs) to BMS-986012 (i.e. incidence of positive ADAs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04702880
Brief Title
A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer
Official Title
A Randomized, Open-label Phase 2 Clinical Trial of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
February 19, 2024 (Anticipated)
Study Completion Date
March 17, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to demonstrate that treatment with BMS-986012 in combination with carboplatin, etoposide, and nivolumab will have acceptable safety and tolerability and will improve progression-free survival compared with carboplatin, etoposide, and nivolumab alone in newly diagnosed participants with extensive-stage small cell lung cancer (ES-SCLC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive-stage Small Cell Lung Cancer
Keywords
BMS-986012, Carboplatin, Etoposide, Extensive-stage small cell lung cancer, Fucosyl, Nivolumab, Targeted SCLC therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012
Arm Type
Experimental
Arm Title
Arm B: Carboplatin + Etoposide + Nivolumab
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
BMS-986012
Other Intervention Name(s)
Fucosyl-GM1 Antibody
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Time Frame
Up to 2 years and 100 days
Title
Incidence of serious adverse events (SAEs)
Time Frame
Up to 2 years and 128 days
Title
Incidence of AEs leading to discontinuation
Time Frame
Up to 2 years and 128 days
Title
Incidence of deaths
Time Frame
Up to 2 years and 128 days
Title
Progression-free survival (PFS) by blinded independent central review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Progression-free survival rate (PFSR)
Description
PFS by BICR based on RECIST v1.1 criteria
Time Frame
6 and 12 months
Title
PFS by investigator based on RECIST v1.1 criteria
Time Frame
Up to 2 years
Title
PFSR
Description
PFS by investigator based on RECIST v1.1 criteria
Time Frame
6 and 12 months
Title
Objective response rate (ORR) based on RECIST v1.1 criteria
Time Frame
Up to 2 years
Title
Time to response (TTR) based on RECIST v1.1 criteria
Time Frame
Up to 2 years
Title
Duration of response (DOR) based on RECIST v1.1 criteria
Time Frame
Up to 2 years
Title
Overall survival (OS)
Description
By arm
Time Frame
Up to 3 years
Title
Overall survival rate (OSR)
Description
By arm
Time Frame
Up to 3 years
Title
Immunogenicity of BMS-986012 measured by assessment of the presence of specific anti-drug antibodies (ADAs) to BMS-986012 (i.e. incidence of positive ADAs)
Time Frame
Up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC) and extensive-stage disease (American Joint Committee on Cancer, 8th edition, Stage IV [T any, N any, M1a, M1b, or M1c], or T3-4 due to multiple lung nodules that are too extensive or tumor or nodal volume that is too large to be encompassed in a tolerable radiation plan)
Participants taking part in the separate PET tracer sub-study must provide a fresh tumor biopsy from any disease site (primary or metastatic)
Archived tumor specimens, in the form of blocks or sectioned slides, are mandatory for all participants except those participating in the separate PET tracer sub-study for whom the archived tumor specimen is optional
Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
At least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria
Adequate hematologic and end organ function
Must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
Women who are pregnant or breastfeeding. Japan only: participation in the study is not allowed even if breastfeeding is suspended
Prior chemotherapy, radiation therapy, or biologic therapy for SCLC. Previously treated limited stage SCLC (LS-SCLC) participants are also excluded
Symptomatic brain or other central nervous system (CNS) metastases
Paraneoplastic autoimmune syndrome requiring systemic treatment
History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan
Grade ≥ 2 peripheral sensory neuropathy at study entry
Significant uncontrolled cardiovascular disease
Active, known or suspected autoimmune disease or inflammatory disorder
Other protocol-defined inclusion/exclusion criteria apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain NCT # and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0075
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0022
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0002
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0060
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0059
Facility Name
Local Institution - 0067
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5055
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0081
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0057
Facility Name
Local Institution - 0003
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Completed
Facility Name
Local Institution - 0023
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0078
City
Ballarat Central
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0001
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Individual Site Status
Completed
Facility Name
Local Institution - 0004
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0051
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0051
Facility Name
Local Institution - 0034
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0034
Facility Name
Local Institution - 0050
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0050
Facility Name
Local Institution - 0012
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Completed
Facility Name
Local Institution - 0064
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0045
City
Heraklion
State/Province
Irakleío
ZIP/Postal Code
715 00
Country
Greece
Individual Site Status
Completed
Facility Name
Local Institution - 0036
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0038
City
Athens
ZIP/Postal Code
185 47
Country
Greece
Individual Site Status
Completed
Facility Name
Casa di Cura Dott. Pederzoli
City
Peschiera del Garda
ZIP/Postal Code
37019
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0031
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Individual Site Status
Completed
Facility Name
Humanitas-U.O di Oncologia medica ed Ematologia
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0073
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0070
City
Osaka-Sayama City
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Completed
Facility Name
Local Institution - 0069
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
5698686
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0077
City
Ina-machi
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Individual Site Status
Completed
Facility Name
Local Institution - 0039
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0039
Facility Name
Local Institution - 0066
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0066
Facility Name
Local Institution - 0040
City
Groningen
ZIP/Postal Code
9700RB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0040
Facility Name
Local Institution - 0079
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0079
Facility Name
Local Institution
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0052
Facility Name
Local Institution - 0049
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0048
City
Łódź
ZIP/Postal Code
93-338
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0043
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0042
City
Cluj
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0041
City
Craiova
ZIP/Postal Code
200542
Country
Romania
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0007
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0021
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0005
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0006
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
36275912
Citation
Chu Q, Leighl NB, Surmont V, van Herpen C, Sibille A, Markman B, Clarke S, Juergens RA, Rivera MA, Andelkovic V, Rudin CM, Snow S, Kim DW, Sanatani M, Lin H, Sanghavi K, Tannenbaum-Dvir S, Basciano P, Lathers D, Urbanska K, Kollia G, He C, DiPiero A, Liu Y, Ready N. BMS-986012, an Anti-Fucosyl-GM1 Monoclonal Antibody as Monotherapy or in Combination With Nivolumab in Relapsed/Refractory SCLC: Results From a First-in-Human Phase 1/2 Study. JTO Clin Res Rep. 2022 Aug 27;3(11):100400. doi: 10.1016/j.jtocrr.2022.100400. eCollection 2022 Nov.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer
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