CompletedPhase 4NCT02869789

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

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.

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

StatusCompleted
PhasePhase 4
U.S. locations136
SponsorBristol-Myers Squibb
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

Inclusion 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 Exclusion 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/exclusion criteria apply

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

04
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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