BMS-986012 in Relapsed/Refractory SCLC

Study summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986012 alone and in combination with nivolumab in patients with relapsed/refractory SCLC.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBMS-986012 (anti-fucosyl-GM1) and Nivolumab

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Recurrent or relapsed · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 5, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

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What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?16 U.S. locations

Locations may change over time.

Who runs it?Bristol-Myers Squibb

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Bristol-Myers Squibb
Interventions being studied: Biological: BMS-986012 (anti-fucosyl-GM1); Biological: Nivolumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Disease setting

Recurrent or relapsed→Resistant or refractory→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Histological or cytological confirmed small cell lung cancer (SCLC)
Performance Status 0-1
Adequate organ function
Measurable disease

Reasons someone may not be able to joinExclusion criteria

Known or suspected brain metastasis
Small cell cancer not lung in origin
Significant or acute medical illness
Uncontrolled or significant cardiac disease
Infection
≥ Grade 2 peripheral neuropathy
Concomitant malignancies
HIV related disease or known or suspected HIV+
Hepatitis B or C infection
ECG abnormalities as defined by the protocol
Allergies or hypersensitivities to monoclonal antibodies, BMS-986012 or related compounds, including fucosyl-GM1 vaccine and Nivolumab Other protocol defined inclusion/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Local Institution - 0004New York, New York
Local Institution - 0001Durham, North Carolina
Local Institution - 0021Winston-Salem, North Carolina
Local Institution - 0020St Leonards, New South Wales
Local Institution - 0011Brisbane, Queensland
Local Institution - 0002Clayton, Victoria
Local Institution - 0015Ghent
Local Institution - 0012Liège
Local Institution - 0003Edmonton, Alberta
Local Institution - 0017Halifax, Nova Scotia
Local Institution - 0019Hamilton, Ontario
Local Institution - 0010London, Ontario

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 5, 2024. Always confirm current availability with the study team.

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