An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers

Study summary

A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNivolumab in combination with Ipilimumab

The study team can explain what participation involves.

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

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 15, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 4

Interventional

Where is it offered?136 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 4
Sponsor: Bristol-Myers Squibb
Interventions being studied: Drug: Nivolumab in combination with 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→

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 4 or recurrent non-small cell lung cancer
Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer)
No prior systemic anticancer therapy (including EGFR and ALK inhibitors)
Tissue or Programmed death-ligand 1 (PD-L1) results available Cohort 1A Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) score 2 or
Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol Cohort C Inclusion Criteria:
High Tumor Mutation Burden

Reasons someone may not be able to joinExclusion criteria

Untreated brain metastases
An active malignancy that requires concurrent intervention
Active, known or suspected autoimmune disease
Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer 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 - 0121Birmingham, Alabama
Local Institution - 0148Phoenix, Arizona
Local Institution - 0085Tucson, Arizona
Local Institution - 0164Little Rock, Arkansas
Local Institution - 0146Bakersfield, California
Marin Cancer Care, IncGreenbrae, California
Los Angeles Hematology/Oncology Medical GroupLos Angeles, California
Local Institution - 0115Los Angeles, California
Torrance Health AssociationRedondo Beach, California
Va San Diego Healthcare SystemSan Diego, California
Local Institution - 0143San Luis Obispo, California
Local Institution - 0144Santa Maria, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 15, 2023. Always confirm current availability with the study team.

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