An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Study summary

The purpose of this study is to explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNivolumab and Ipilimumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 20, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?35 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 2
Sponsor: Bristol-Myers Squibb
Interventions being studied: Biological: Nivolumab; Biological: Ipilimumab

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How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→Recurrent or relapsed→

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

Histologically confirmed, stage IV or recurrent non-small cell lung cancer with no prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease
Measurable disease by CT or MRI
Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work

Reasons someone may not be able to joinExclusion criteria

Participants with untreated central nervous system metastases
Participants with active, known or suspected autoimmune disease
Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors) 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 - 0006Springdale, Arkansas
Local Institution - 0001New Haven, Connecticut
Local Institution - 0005Jacksonville, Florida
Local Institution - 0009Atlanta, Georgia
Local Institution - 0003St Louis, Missouri
Local Institution - 0038The Bronx, New York
Local Institution - 0002Cleveland, Ohio
Local Institution - 0008Cleveland, Ohio
Local Institution - 0007Greenville, South Carolina
Local Institution - 0004Nashville, Tennessee
Local Institution - 0017La Louvière, Hainaut
Local Institution - 0018Ghent

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 20, 2024. Always confirm current availability with the study team.

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