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

  • Clinicaltrials.gov identifier

    NCT04702880

  • Recruitment Status

    Recruiting

  • First Posted

    January 11, 2021

  • Last update posted

    May 3, 2022

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:Extensive-stage Small Cell Lung Cancer
  • Intervention/Treatment: Biological: BMS-986012
    Drug: Carboplatin
    Drug: Etoposide
    Biological: Nivolumab
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 120 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study 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: March 2021
  • Estimated Primary Completion Date: February 2024
  • Estimated Study Completion Date: March 2025

Arms and interventions

Arm Intervention/treatment
Experimental: Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012
Biological: BMS-986012
Specified dose on specified days

Drug: Carboplatin
Specified dose on specified days

Drug: Etoposide
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
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

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of adverse events (AEs) [ Time Frame: Up to 2 years and 100 days ]
  • 2. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 2 years and 128 days ]
  • 3. Incidence of AEs leading to discontinuation [ Time Frame: Up to 2 years and 128 days ]
  • 4. Incidence of deaths [ Time Frame: 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 [ Time Frame: Up to 2 years ]
  • Secondary Outcome Measures: 1. Progression-free survival rate (PFSR) [ Time Frame: 6 and 12 months ]
    PFS by BICR based on RECIST v1.1 criteria
  • 2. PFS by investigator based on RECIST v1.1 criteria [ Time Frame: Up to 2 years ]
  • 3. PFSR [ Time Frame: 6 and 12 months ]
    PFS by investigator based on RECIST v1.1 criteria
  • 4. Objective response rate (ORR) based on RECIST v1.1 criteria [ Time Frame: Up to 2 years ]
  • 5. Time to response (TTR) based on RECIST v1.1 criteria [ Time Frame: Up to 2 years ]
  • 6. Duration of response (DOR) based on RECIST v1.1 criteria [ Time Frame: Up to 2 years ]
  • 7. Overall survival (OS) [ Time Frame: Up to 3 years ]
    By arm
  • 8. Overall survival rate (OSR) [ Time Frame: Up to 3 years ]
    By arm
  • 9. Measures of tumor fucosyl-GM1 (fuc-GM1) expression by immunohistochemistry (IHC) [ Time Frame: 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) [ Time Frame: Up to 2 years ]
  • 11. Measures of tumor fucosyl-GM1 (fuc-GM1) expression by targeted mass spectrometry [ Time Frame: 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) [ Time Frame: Up to 2 years ]
  • 13. Measures of tumor programmed cell death-ligand 1 (PD-L1) expression combined positive score (CPS) at baseline [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Up to 2 years ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Alabama
Local Institution
Birmingham

United States, Florida
Local Institution
Tampa

United States, Kentucky
Local Institution
Lexington

United States, New Jersey
John Theurer Cancer Center
Hackensack

United States, North Carolina
Duke Cancer Institute
Durham

United States, Ohio
Local Institution
Cincinnati

United States, Ohio
University Of Cincinnati Medical Center
Cincinnati

United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland

United States, Texas
Local Institution
Dallas

Australia, New South Wales
Local Institution - 0003
Westmead

Australia, Queensland
Local Institution - 0023
Greenslopes

Australia, Victoria
Local Institution
Ballarat

Australia, Victoria
Cabrini Hospital
Malvern

Australia, Western Australia
Local Institution - 0004
Murdoch

Belgium
Local Institution
Charleroi

Belgium
Local Institution
Gent

Belgium
Local Institution
Liège

Canada, Alberta
Local Institution
Edmonton

Canada, Ontario
Local Institution - 0064
Brampton

Greece
Local Institution
Athens

Greece
Local Institution
Athens

Greece
Local Institution
Irakleio

Italy
Local Institution - 0030
Peschiera del Garda

Italy
Local Institution
Pisa

Italy
Local Institution - 0029
Rozzano

Japan, Miyagi
Local Institution - 0073
Sendai

Japan, Osaka
Local Institution
Osaka-Sayama City

Japan, Osaka
Local Institution
Takatsuki

Japan
Local Institution
Saitama

Netherlands
Local Institution - 0039
Amsterdam

Netherlands
Local Institution
Arnhem

Netherlands
Local Institution
Groningen

Netherlands
Local Institution
Leiden

Netherlands
Local Institution
Nijmegen

Poland
Local Institution - 0049
Gdansk

Poland
Local Institution - 0048
Łódź

Romania
Local Institution
Bucharest

Romania
Local Institution
Cluj-Napoca

Romania
Local Institution
Craiova

Spain
Local Institution - 0007
Barcelona

Spain
Local Institution
Madrid

Spain
Local Institution
Majadahonda

Spain
Local Institution
Malaga

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04702880 History of Changes
  • Other Study ID Numbers: CA001-050, 2020-001863-10, U1111-1250-4427
  • First Posted: January 11, 2021 Key Record Dates
  • Last Update Posted: May 3, 2022
  • Last Verified: April 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
    Respiratory Tract Neoplasms
    Thoracic Neoplasms
    Neoplasms by Site
    Neoplasms
    Lung Diseases
    Respiratory Tract Diseases
    Carcinoma, Bronchogenic
    Bronchial Neoplasms