Clincosm LogoSign in Get a demo

A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04702880
Collaborator
(none)
120
Enrollment
43
Locations
2
Arms
48
Anticipated Duration (Months)
2.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 17, 2021
Anticipated Primary Completion Date :
Feb 19, 2024
Anticipated Study Completion Date :
Mar 17, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012

Biological: BMS-986012
Specified dose on specified days
Other Names:
  • Fucosyl-GM1 Antibody

    • Drug: Carboplatin
    Specified dose on specified days

    Drug: Etoposide
    Specified dose on specified days

    Biological: Nivolumab
    Specified dose on specified days
    Other Names:
  • BMS-936558

    		•
    Experimental: Arm B: Carboplatin + Etoposide + Nivolumab

    Drug: Carboplatin
    Specified dose on specified days

    Drug: Etoposide
    Specified dose on specified days

    Biological: Nivolumab
    Specified dose on specified days
    Other Names:
  • BMS-936558

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events (AEs) [Up to 2 years and 100 days]

    2. Incidence of serious adverse events (SAEs) [Up to 2 years and 128 days]

    3. Incidence of AEs leading to discontinuation [Up to 2 years and 128 days]

    4. Incidence of deaths [Up to 2 years and 128 days]

    5. Progression-free survival (PFS) by blinded independent central review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria [Up to 2 years]

    Secondary Outcome Measures

    1. Progression-free survival rate (PFSR) [6 and 12 months]

      PFS by BICR based on RECIST v1.1 criteria

    2. PFS by investigator based on RECIST v1.1 criteria [Up to 2 years]

    3. PFSR [6 and 12 months]

      PFS by investigator based on RECIST v1.1 criteria

    4. Objective response rate (ORR) based on RECIST v1.1 criteria [Up to 2 years]

    5. Time to response (TTR) based on RECIST v1.1 criteria [Up to 2 years]

    6. Duration of response (DOR) based on RECIST v1.1 criteria [Up to 2 years]

    7. Overall survival (OS) [Up to 3 years]

      By arm

    8. Overall survival rate (OSR) [Up to 3 years]

      By arm

    9. Measures of tumor fucosyl-GM1 (fuc-GM1) expression by immunohistochemistry (IHC) [Up to 2 years]

    10. Measures of tumor fucosyl-GM1 (fuc-GM1) expression association with measures of anti-tumor activity measures (eg, ORR, PFS) (IHC) [Up to 2 years]

    11. Measures of tumor fucosyl-GM1 (fuc-GM1) expression by targeted mass spectrometry [Up to 2 years]

    12. Measures of tumor fucosyl-GM1 (fuc-GM1) expression association with measures of anti-tumor activity measures (eg, ORR, PFS) (targeted mass spectrometry) [Up to 2 years]

    13. Measures of tumor programmed cell death-ligand 1 (PD-L1) expression combined positive score (CPS) at baseline [Up to 2 years]

    14. Measures of tumor programmed cell death-ligand 1 (PD-L1) expression association with measures of anti-tumor activity (eg, ORR, PFS) [Up to 2 years]

    15. 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) [Up to 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC) and extensive-stage disease (American Joint Committee on Cancer, 7th edition, Stage IV [T any, N any, M1a, or M1b], 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)

    • Must provide a fresh tumor biopsy from the primary disease site (when possible) or from any metastatic site when the primary site is not available

    • 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 (Response Evaluation Criteria in Solid Tumors (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

    • Prior chemotherapy, radiation therapy, or biologic therapy for small cell lung cancer (SCLC) for first-line treatment

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Birmingham Alabama United States 35233
    2 Local Institution Tampa Florida United States 33612
    3 Local Institution Lexington Kentucky United States 40503
    4 John Theurer Cancer Center Hackensack New Jersey United States 07601
    5 Duke Cancer Institute Durham North Carolina United States 27710
    6 Local Institution Cincinnati Ohio United States 45267
    7 University Of Cincinnati Medical Center Cincinnati Ohio United States 45267
    8 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106-5055
    9 Local Institution Dallas Texas United States 75390
    10 Local Institution - 0003 Westmead New South Wales Australia 2145
    11 Local Institution - 0023 Greenslopes Queensland Australia 4120
    12 Local Institution Ballarat Victoria Australia 3350
    13 Cabrini Hospital Malvern Victoria Australia 3144
    14 Local Institution - 0004 Murdoch Western Australia Australia 6150
    15 Local Institution Charleroi Belgium 6000
    16 Local Institution Gent Belgium 9000
    17 Local Institution Liège Belgium 4000
    18 Local Institution Edmonton Alberta Canada T6G 1Z2
    19 Local Institution - 0064 Brampton Ontario Canada L6R 3J7
    20 Local Institution Athens Greece 11527
    21 Local Institution Athens Greece 18547
    22 Local Institution Irakleio Greece 71110
    23 Local Institution - 0030 Peschiera del Garda Italy 37019
    24 Local Institution Pisa Italy 56124
    25 Local Institution - 0029 Rozzano Italy 20089
    26 Local Institution - 0073 Sendai Miyagi Japan 980-0873
    27 Local Institution Osaka-Sayama City Osaka Japan 589-8511
    28 Local Institution Takatsuki Osaka Japan 5691116
    29 Local Institution Saitama Japan 362-0806
    30 Local Institution - 0039 Amsterdam Netherlands 1081 HV
    31 Local Institution Arnhem Netherlands 6815 AD
    32 Local Institution Groningen Netherlands 9713 GZ
    33 Local Institution Leiden Netherlands 2333 ZA
    34 Local Institution Nijmegen Netherlands 6500 HB
    35 Local Institution - 0049 Gdansk Poland 80-214
    36 Local Institution - 0048 Łódź Poland 93-338
    37 Local Institution Bucharest Romania 022328
    38 Local Institution Cluj-Napoca Romania 400015
    39 Local Institution Craiova Romania 200347
    40 Local Institution - 0007 Barcelona Spain 08035
    41 Local Institution Madrid Spain 28041
    42 Local Institution Majadahonda Spain 28222
    43 Local Institution Malaga Spain 29010

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT04702880
    Other Study ID Numbers:
    • CA001-050
    • 2020-001863-10
    • U1111-1250-4427
    First Posted:
    Jan 11, 2021
    Last Update Posted:
    May 3, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    BMS-986012
    Carboplatin
    Etoposide
    Extensive-stage small cell lung cancer
    Fucosyl
    Nivolumab
    Targeted SCLC therapy
    Additional relevant MeSH terms:
    Lung Neoplasms
    Small Cell Lung Carcinoma
    Carboplatin
    Nivolumab
    Etoposide

    Study Results

    No Results Posted as of May 3, 2022