An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02743494
Phase
PHASE3
Status
Completed

Conditions

  • Advanced Cancer

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Specified dose on specified days
  • Placebo — OTHER
    Specified dose on specified days

Study Details

The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.

Key Dates

Start date
Jul 14, 2016
Status verified
Nov 2025
Primary completion
May 12, 2020
Completion
Nov 7, 2024

Study Design

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

Arms

  • Experimental: Nivolumab
  • Placebo Comparator: Placebo

Primary Outcome Measure

Disease-free Survival (DFS) [ Time Frame: From randomization to the date of recurrence or death (up to approximately 46 months) ]

Locations (38)

FacilityCityStateZIPSite coordinators
Local Institution - 0250TucsonArizona85711-
Local Institution - 0026Los AngelesCalifornia90033-
Local Institution - 0023San FranciscoCalifornia94115-
Local Institution - 0068San FranciscoCalifornia94158-
Local Institution - 0151AuroraColorado80045-
Local Institution - 0247DenverColorado80218-
Local Institution - 0054Washington D.C.District of Columbia20007-
Local Institution - 0113Fort MyersFlorida33901-
Local Institution - 0131JacksonvilleFlorida32256-
Local Institution - 0226MiamiFlorida33136-
Local Institution - 0022PensacolaFlorida32504-
Local Institution - 0114St. PetersburgFlorida33705-
Local Institution - 0153ChicagoIllinois60637-
Local Institution - 0025BaltimoreMaryland21202-
Local Institution - 0055BostonMassachusetts02215-
Local Institution - 0170BostonMassachusetts02215-
Local Institution - 0171BostonMassachusetts02215-
Local Institution - 0217BostonMassachusetts02215-
Local Institution - 0027St LouisMissouri63110-
Local Institution - 0058HackensackNew Jersey07601-
Local Institution - 0066Neptune CityNew Jersey07753-
Local Institution - 0032New YorkNew York10016-
Local Institution - 0205The BronxNew York10461-
Local Institution - 0033CharlotteNorth Carolina28262-
Local Institution - 0024DurhamNorth Carolina27710-
Local Institution - 0056ClevelandOhio44106-
Local Institution - 0165PortlandOregon97239-
Local Institution - 0101AllentownPennsylvania18103-
Local Institution - 0048PhiladelphiaPennsylvania19111-
Local Institution - 0116PittsburghPennsylvania15212-
Local Institution - 0111NashvilleTennessee37203-
Local Institution - 0130NashvilleTennessee37232-
Local Institution - 0216DallasTexas75216-
Local Institution - 0248DallasTexas75246-
Local Institution - 0012HoustonTexas77030-4009-
Local Institution - 0067SeattleWashington98109-
Local Institution - 0241SeattleWashington98101-
Local Institution - 0069MadisonWisconsin53792-

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