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)

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03001882
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Ipilimumab — BIOLOGICAL
    Specified dose on specified days

Study Details

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).

Key Dates

Start date
Mar 29, 2017
Status verified
Apr 2024
Primary completion
Feb 17, 2022
Completion
Apr 24, 2023

Study Design

Enrollment
230 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination therapy
    Nivolumab + Ipilimumab

Primary Outcome Measure

Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (TMB Cut-point = 16 Mutations/MB) [ Time Frame: From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months) ]

Locations (10)

FacilityCityStateZIPSite coordinators
Local Institution - 0006SpringdaleArkansas72762-
Local Institution - 0001New HavenConnecticut06520-
Local Institution - 0005JacksonvilleFlorida32256-
Local Institution - 0009AtlantaGeorgia30322-
Local Institution - 0003St LouisMissouri63110-
Local Institution - 0038The BronxNew York10461-
Local Institution - 0002ClevelandOhio44195-
Local Institution - 0008ClevelandOhio44195-
Local Institution - 0007GreenvilleSouth Carolina29607-
Local Institution - 0004NashvilleTennessee37203-

Find similar trials in Springdale, AR

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Local Institution - 0006· Springdale, ARLocal Institution - 0001· New Haven, CTLocal Institution - 0005· Jacksonville, FLLocal Institution - 0009· Atlanta, GALocal Institution - 0003· St Louis, MOLocal Institution - 0038· The Bronx, NY

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