An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer

Part of paid clinical trials in Daphne, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03338790
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • nivolumab — BIOLOGICAL
    Specified dose on specified days
  • docetaxel — DRUG
    Specified dose on specified days
  • enzalutamide — DRUG
    Specified dose on specified days
  • rucaparib — DRUG
    Specified dose on specified days
  • prednisone — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to assess safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spread.

Key Dates

Start date
Dec 19, 2017
Status verified
Jan 2026
Primary completion
Jan 13, 2021
Completion
Jan 10, 2025

Study Design

Enrollment
292 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: nivolumab + rucaparib
    Specified dose on specified days
  • Experimental: nivolumab + docetaxel + prednisone
    Specified dose on specified days
  • Experimental: nivolumab + enzalutamide
    Specified dose on specified days

Primary Outcome Measure

Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3) [ Time Frame: Up to approximately 36 months ]

Locations (19)

FacilityCityStateZIPSite coordinators
Local Institution - 0036DaphneAlabama36526-
Local Institution - 0010Rancho MirageCalifornia92270-
Local Institution - 0049New HavenConnecticut06520-
Local Institution - 0037MiamiFlorida33176-
Local Institution - 0009MariettaGeorgia30060-
Local Institution - 0065LouisvilleKentucky40207-
Tulane UniversityNew OrleansLouisiana70112-
Local Institution - 0040RockvilleMaryland20850-
Boston Medical CenterBostonMassachusetts02118-
Local Institution - 0012DetroitMichigan48201-
Local Institution - 0069JacksonMississippi39202-
Local Institution - 0011St LouisMissouri63110-
Local Institution - 0035OmahaNebraska68130-
Local Institution - 0038AlbanyNew York12208-
Local Institution - 0068New YorkNew York10032-
Local Institution - 0041DurhamNorth Carolina27710-
Local Institution - 0024PortlandOregon97225-
Local Institution - 0053AllentownPennsylvania18103-
Local Institution - 0039FairfaxVirginia22031-

Find similar trials in Daphne, AL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Local Institution - 0036· Daphne, ALLocal Institution - 0010· Rancho Mirage, CALocal Institution - 0049· New Haven, CTLocal Institution - 0037· Miami, FLLocal Institution - 0009· Marietta, GALocal Institution - 0065· Louisville, KY

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