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

NCT04702880 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: CA001-0502020-001863-10U1111-1250-4427
• Study Type: interventional
• Target: 135
• Locations: 11 countries
• Sites: 39

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).

Conditions

Extensive-stage Small Cell Lung Cancer

Keywords

BMS-986012; Carboplatin; Etoposide; Extensive-stage small cell lung cancer; Fucosyl; Nivolumab; Targeted SCLC therapy

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Adverse Events

  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 treatment that does not necessarily have a causal relationship with this treatment.

  From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months)

• Number of Participants With Serious Adverse Events

  Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

  From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months)

• Number of Participants With Adverse Events 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 treatment that does not necessarily have a causal relationship with this treatment.

  From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months)

• Number of Participants Who Died

  Number of participants who died due to any cause.

  From first dose to primary cutoff date (Up to approximately 43 months)

• Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)

  PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by BICR or death from any cause. Estimates are based on Kaplan-Meier product-limit method. Progressive disease=At least a 20% increase in the sum of diameters of target lesions.

  From randomization to the date of the first documented tumor progression, or death, or primary cutoff date, whichever occurs first (Up to approximately 50 months)

Secondary Outcomes (8)

• Progression Free Survival Rate (PFSR) at 6 and 12 Months

  6 and 12 months

• Progression Free Survival (PFS) Per Investigator

  From randomization to the date of the first documented tumor progression, or death, whichever occurs first (Up to approximately 56 months)

• Objective Response Rate (ORR)

  From randomization to the date of first documented response (Up to approximately 56 months)

• Duration of Response (DoR)

  From randomization to the date of the documentation of disease progression or death due to any cause, whichever is earlier (Up to approximately 56 months)

• Time to Response (TTR)

  From randomization to the date of first documented CR or PR (Up to approximately 56 months)

Study Arms (2)

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

EXPERIMENTAL

Biological: BMS-986012; Drug: Carboplatin; Drug: Etoposide; Biological: Nivolumab

Arm B: Carboplatin + Etoposide + Nivolumab

EXPERIMENTAL

Drug: Carboplatin; Drug: Etoposide; Biological: Nivolumab

Interventions

BMS-986012 BIOLOGICAL

Specified dose on specified days

Also known as: Fucosyl-GM1 Antibody

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

Carboplatin DRUG

Specified dose on specified days

Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012; Arm B: Carboplatin + Etoposide + Nivolumab

Etoposide DRUG

Specified dose on specified days

Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012; Arm B: Carboplatin + Etoposide + Nivolumab

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-936558

Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012; Arm B: Carboplatin + Etoposide + Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (39)

Local Institution - 0075

Birmingham, Alabama, 35249, United States

Location

Local Institution - 0022

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0002

Durham, North Carolina, 27710, United States

Location

Local Institution - 0060

Cincinnati, Ohio, 45267, United States

Location

Local Institution

Cincinnati, Ohio, 45267, United States

Location

Local Institution - 0067

Cleveland, Ohio, 44106-1716, United States

Location

Local Institution - 0081

Nashville, Tennessee, 37203, United States

Location

Local Institution

Dallas, Texas, 75390, United States

Location

Local Institution - 0003

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 0023

Greenslopes, Queensland, 4120, Australia

Location

Local Institution - 0001

Malvern, Victoria, 3144, Australia

Location

Local Institution - 0004

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 0051

Charleroi, Hainaut, 6060, Belgium

Location

Local Institution - 0034

Ghent, 9000, Belgium

Location

Local Institution - 0050

Liège, 4000, Belgium

Location

Local Institution - 0012

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution - 0064

Brampton, Ontario, L6R 3J7, Canada

Location

Local Institution - 0045

Heraklion, Irakleío, 715 00, Greece

Location

Local Institution - 0036

Athens, 11527, Greece

Location

Local Institution - 0038

Athens, 185 47, Greece

Location

Local Institution - 0030

Peschiera del Garda, 37019, Italy

Location

Local Institution - 0031

Pisa, 56124, Italy

Location

Local Institution - 0029

Rozzano, 20089, Italy

Location

Local Institution - 0073

Sendai, Miyagi, 980-0873, Japan

Location

Local Institution - 0070

Ōsaka-sayama, Osaka, 589-8511, Japan

Location

Local Institution - 0069

Takatsuki, Osaka, 5698686, Japan

Location

Local Institution - 0077

Ina-machi, Saitama, 362-0806, Japan

Location

Local Institution - 0039

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Local Institution - 0066

Arnhem, 6815 AD, Netherlands

Location

Local Institution - 0040

Groningen, 9700RB, Netherlands

Location

Local Institution - 0049

Gdansk, 80-214, Poland

Location

Local Institution - 0048

Lodz, 93-338, Poland

Location

Local Institution - 0043

Bucharest, 022328, Romania

Location

Local Institution - 0042

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0041

Craiova, 200542, Romania

Location

Local Institution - 0007

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Local Institution - 0021

Madrid, 28041, Spain

Location

Local Institution - 0005

Majadahonda, 28222, Spain

Location

Local Institution - 0006

Málaga, 29010, Spain

Location

Related Publications (1)

• 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.

  PMID: 36275912 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Carboplatin; Etoposide; Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email:

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: March 17, 2021
• Primary Completion: May 22, 2025
• Study Completion: November 28, 2025
• Last Updated: June 17, 2026
• Results First Posted: June 17, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

PL (2); CA (2); RO (3); GR (3); AU (4); BE (3); JP (4); IT (3); NL (3); ES (4); US (8)