A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer

Study summary

A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab

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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 Apr 17, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?17 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 3
Sponsor: Bristol-Myers Squibb
Interventions being studied: Drug: Nivolumab; Drug: 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→Chemotherapy→

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 Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
1\) Stage IV or recurrent non-Small cell lung cancer
2\) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
3\) Prior adjuvant or neoadjuvant chemotherapy for local, advanced disease allowed if completed at least 6 months prior to randomization

Reasons someone may not be able to joinExclusion criteria

1\) Known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma syndrome(ALK) translocations that are sensitive to targeted inhibitor therapy
2\) Active, known or suspected autoimmune disease or HIV infection
3\) Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
4\) Untreated Central Nervous System metastases 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 InstitutionSan Francisco, California
Local InstitutionLincoln, Nebraska
Local InstitutionHackensack, New Jersey
Local InstitutionColumbus, Ohio
Local InstitutionLancaster, Pennsylvania
Local InstitutionLanghorne, Pennsylvania
Local InstitutionSayre, Pennsylvania
Local InstitutionCharleston, South Carolina
Local InstitutionSt. George, Utah
Local InstitutionViedma, Río Negro Province
Local InstitutionMontreal, Quebec
Local InstitutionDresden

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 17, 2018. Always confirm current availability with the study team.

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