A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04100018
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Prednisone — DRUG
    Specified dose on specified days
  • Docetaxel — DRUG
    Specified dose on specified days
  • Placebo — OTHER
    Specified dose on specified days

Study Details

The purpose of this study is to assess the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.

Key Dates

Start date
Feb 6, 2020
Status verified
May 2025
Primary completion
Jun 1, 2023
Completion
Jun 25, 2024

Study Design

Enrollment
1,030 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Nivolumab + docetaxel + prednisone
  • Placebo Comparator: Arm B: Placebo + docetaxel + prednisone

Primary Outcome Measure

Radiographic Progressive Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group 3 (PCWG3) [ Time Frame: from randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 31 months) ]

Locations (45)

FacilityCityStateZIPSite coordinators
Local Institution - 0305MobileAlabama36608-1753-
Local Institution - 0012AnchorageAlaska99503-
Local Institution - 0293TucsonArizona85724-
Local Institution - 0269JonesboroArkansas72401-
Local Institution - 0179OrangeCalifornia92868-
Local Institution - 0055Rancho MirageCalifornia92270-
Local Institution - 0260Redondo BeachCalifornia90277-
Local Institution - 0081Santa MonicaCalifornia90404-
Local Institution - 0087DenverColorado80211-5222-
Local Institution - 0190West HavenConnecticut06516-5907-
Local Institution - 0366Washington D.C.District of Columbia20010-3017-
Local Institution - 0196HollywoodFlorida33021-
Local Institution - 0397JacksonvilleFlorida32256-
Local Institution - 0164LakelandFlorida33805-
Local Institution - 0181OrlandoFlorida32806-
Local Institution - 0285PensacolaFlorida32503-
Local Institution - 0177WestonFlorida33331-
Local Institution - 0117AtlantaGeorgia30342-
Local Institution - 0126MariettaGeorgia30060-
Local Institution - 0382ThomasvilleGeorgia31792-
Local Institution - 0287NilesIllinois60714-
Local Institution - 0183Fort WayneIndiana46804-
Local Institution - 0302LouisvilleKentucky40202-
Local Institution - 0150BaltimoreMaryland21201-
Local Institution - 0332BrandywineMaryland20613-
Local Institution - 0299OmahaNebraska68130-
Local Institution - 0365East BrunswickNew Jersey08816-
Local Institution - 0139Florham ParkNew Jersey07932-
Local Institution - 0300AlbanyNew York12208-
Local Institution - 0028Port Jefferson StationNew York11776-
Local Institution - 0333ColumbusOhio43210-
Local Institution - 0180AllentownPennsylvania18103-6218-
Local Institution - 0074Bala-CynwydPennsylvania19004-
Local Institution - 0292PittsburghPennsylvania15232-
Local Institution - 0233CharlestonSouth Carolina29414-
Local Institution - 0115Myrtle BeachSouth Carolina29572-4607-
Local Institution - 0149GermantownTennessee38138-
Local Institution - 0286AustinTexas75251-
Local Institution - 0303DallasTexas75251-
Local Institution - 0195HoustonTexas77030-3721-
Local Institution - 0284HoustonTexas77024-2843-
Local Institution - 0011San AntonioTexas78229-
The University of Texas Health Science Center at Tyler DBA UT Health East Texas Hope Cancer CenterTylerTexas75701-
Local Institution - 0110SeattleWashington98109-
Local Institution - 0289SpokaneWashington99208-

Find similar trials in Mobile, AL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Local Institution - 0305· Mobile, ALLocal Institution - 0012· Anchorage, AKLocal Institution - 0293· Tucson, AZLocal Institution - 0269· Jonesboro, ARLocal Institution - 0179· Orange, CALocal Institution - 0055· Rancho Mirage, CA

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