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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04702880




Registration number
NCT04702880
Ethics application status
Date submitted
7/01/2021
Date registered
11/01/2021
Date last updated
17/07/2024

Titles & IDs
Public title
A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer
Scientific 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
Secondary ID [1] 0 0
2020-001863-10
Secondary ID [2] 0 0
CA001-050
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extensive-stage 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
Treatment: Other - BMS-986012
Treatment: Drugs - Carboplatin
Treatment: Drugs - Etoposide
Treatment: Other - Nivolumab

Experimental: Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012 -

Experimental: Arm B: Carboplatin + Etoposide + Nivolumab -


Treatment: Other: BMS-986012
Specified dose on specified days

Treatment: Drugs: Carboplatin
Specified dose on specified days

Treatment: Drugs: Etoposide
Specified dose on specified days

Treatment: Other: Nivolumab
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events (AEs)
Timepoint [1] 0 0
Up to 2 years and 100 days
Primary outcome [2] 0 0
Incidence of serious adverse events (SAEs)
Timepoint [2] 0 0
Up to 2 years and 128 days
Primary outcome [3] 0 0
Incidence of AEs leading to discontinuation
Timepoint [3] 0 0
Up to 2 years and 128 days
Primary outcome [4] 0 0
Incidence of deaths
Timepoint [4] 0 0
Up to 2 years and 128 days
Primary outcome [5] 0 0
Progression-free survival (PFS) by blinded independent central review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Timepoint [5] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Progression-free survival rate (PFSR)
Timepoint [1] 0 0
6 and 12 months
Secondary outcome [2] 0 0
PFS by investigator based on RECIST v1.1 criteria
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
PFSR
Timepoint [3] 0 0
6 and 12 months
Secondary outcome [4] 0 0
Objective response rate (ORR) based on RECIST v1.1 criteria
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Time to response (TTR) based on RECIST v1.1 criteria
Timepoint [5] 0 0
Up to 2 years
Secondary outcome [6] 0 0
Duration of response (DOR) based on RECIST v1.1 criteria
Timepoint [6] 0 0
Up to 2 years
Secondary outcome [7] 0 0
Overall survival (OS)
Timepoint [7] 0 0
Up to 3 years
Secondary outcome [8] 0 0
Overall survival rate (OSR)
Timepoint [8] 0 0
Up to 3 years
Secondary outcome [9] 0 0
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)
Timepoint [9] 0 0
Up to 2 years

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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 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
17/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0003 - Westmead
Recruitment hospital [2] 0 0
Local Institution - 0023 - Greenslopes
Recruitment hospital [3] 0 0
Local Institution - 0001 - Malvern
Recruitment hospital [4] 0 0
Local Institution - 0004 - Murdoch
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4120 - Greenslopes
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
New Jersey
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Belgium
State/province [7] 0 0
Charleroi
Country [8] 0 0
Belgium
State/province [8] 0 0
Gent
Country [9] 0 0
Belgium
State/province [9] 0 0
Liège
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Greece
State/province [12] 0 0
Irakleío
Country [13] 0 0
Greece
State/province [13] 0 0
Athens
Country [14] 0 0
Italy
State/province [14] 0 0
Peschiera del Garda
Country [15] 0 0
Italy
State/province [15] 0 0
Pisa
Country [16] 0 0
Italy
State/province [16] 0 0
Rozzano
Country [17] 0 0
Japan
State/province [17] 0 0
Miyagi
Country [18] 0 0
Japan
State/province [18] 0 0
Osaka
Country [19] 0 0
Japan
State/province [19] 0 0
Saitama
Country [20] 0 0
Netherlands
State/province [20] 0 0
Noord-Holland
Country [21] 0 0
Netherlands
State/province [21] 0 0
Arnhem
Country [22] 0 0
Netherlands
State/province [22] 0 0
Groningen
Country [23] 0 0
Poland
State/province [23] 0 0
Gdansk
Country [24] 0 0
Poland
State/province [24] 0 0
Lódz
Country [25] 0 0
Romania
State/province [25] 0 0
Bucharest
Country [26] 0 0
Romania
State/province [26] 0 0
Cluj
Country [27] 0 0
Romania
State/province [27] 0 0
Craiova
Country [28] 0 0
Spain
State/province [28] 0 0
Barcelona [Barcelona]
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
Spain
State/province [30] 0 0
Majadahonda
Country [31] 0 0
Spain
State/province [31] 0 0
Málaga

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 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).
Trial website
https://clinicaltrials.gov/study/NCT04702880
Trial related presentations / publications
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.
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
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04702880