An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy

Part of paid clinical trials in Sacramento, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02538666
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.

Key Dates

Start date
Oct 13, 2015
Status verified
Dec 2022
Primary completion
Oct 1, 2018
Completion
Nov 11, 2021

Study Design

Enrollment
907 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab monotherapy
    Nivolumab intravenous fusion
  • Experimental: Nivolumab and ipilimumab combination therapy
    Nivolumab and ipilimumab intravenous fusion
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population [ Time Frame: From randomization to 400 deaths across the two treatment groups (Nivo+Ipi vs Placebo) (up to approximately 37 months) ]

Locations (28)

FacilityCityStateZIPSite coordinators
Local Institution - 0003SacramentoCalifornia95816-
Local Institution - 0202New HavenConnecticut06520-
Local Institution - 0127Fort MyersFlorida33901-
Local Institution - 0007JacksonvilleFlorida32256-
Local Institution - 0128St. PetersburgFlorida33705-
Local Institution - 0010AtlantaGeorgia30322-
Local Institution - 0013IndianapolisIndiana46237-
Local Institution - 0061FairwayKansas66205-
Local Institution - 0012WichitaKansas67214-
Local Institution - 0032LexingtonKentucky40503-
Local Institution - 0051BaltimoreMaryland21287-
Local Institution - 0107BostonMassachusetts02215-
Local Institution - 0207BostonMassachusetts02215-
Local Institution - 0015St LouisMissouri63110-
Local Institution - 0008New YorkNew York10065-
Local Institution - 0014DurhamNorth Carolina27710-
Local Institution - 0016Winston-SalemNorth Carolina27103-
Local Institution - 0215FargoNorth Dakota58102-
Local Institution - 0129CincinnatiOhio45242-
Local Institution - 0009ColumbusOhio43210-
Local Institution - 0001PortlandOregon97213-
Local Institution - 0034PortlandOregon97239-
Local Institution - 0004AllentownPennsylvania18103-
Local Institution - 0002SayrePennsylvania18840-
Local Institution - 0005CharlestonSouth Carolina29425-
Local Institution - 0213Sioux FallsSouth Dakota57104-
Local Institution - 0011Salt Lake CityUtah84112-
Local Institution - 0006RichmondVirginia23226-

Find similar trials in Sacramento, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Local Institution - 0003· Sacramento, CALocal Institution - 0202· New Haven, CTLocal Institution - 0127· Fort Myers, FLLocal Institution - 0007· Jacksonville, FLLocal Institution - 0128· St. Petersburg, FLLocal Institution - 0010· Atlanta, GA

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