A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant,

Part of paid clinical trials in Duarte, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03138499
Phase
PHASE3
Status
Terminated

Conditions

  • Hodgkin's Disease

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Brentuximab vedotin — BIOLOGICAL
    Specified dose on specified days

Study Details

The purpose of this study is to determine whether an investigational immuno-therapy combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The participants of this trial will comprise of patients who have relapsed or did not respond to treatment and are not eligible for stem cell transplant

Key Dates

Start date
Jun 26, 2017
Status verified
Jan 2024
Primary completion
Feb 22, 2021
Completion
Feb 22, 2021

Study Design

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

Arms

  • Experimental: Module A
    Nivolumab combined with Brentuximab
  • Experimental: Module B
    Brentuximab alone

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From randomization to date of death, or disease progression (up to approximately 45 months) ]

Locations (20)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
Pacific Shores Medical GroupLong BeachCalifornia90813-
UCLA Clinical and Translational Research Center (CTRC)Los AngelesCalifornia90095-1678-
University of Southern CaliforniaLos AngelesCalifornia90033-
Local InstitutionPalo AltoCalifornia94304-
UC Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
University of California San DiegoSan DiegoCalifornia92122-
Hartford Healthcare Cancer Institute at the Hospital of Central ConnecticutPlainvilleConnecticut06062-
Orlando Health, IncOrlandoFlorida32806-
Parkview Cancer CenterFort WayneIndiana46845-
University of Kansas Cancer CenterWestwoodKansas66205-
Tulane University Health Sciences CenterNew OrleansLouisiana70112-
Dana Farber/Harvard Cancer CenterBostonMassachusetts02215-
Karmanos Cancer InstituteDetroitMichigan48201-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Bon Secours Saint Francis Cancer CenterGreenvilleSouth Carolina29607-
Vanderbilt Ingram Cancer CenterNashvilleTennessee37213-
University of Texas Southwestern Medical CenterDallasTexas75390-
The University of Texas MD Anderson Cancer Center-mergeHoustonTexas77030-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAPacific Shores Medical Group· Long Beach, CAUCLA Clinical and Translational Research Center (CTRC)· Los Angeles, CAUniversity of Southern California· Los Angeles, CALocal Institution· Palo Alto, CAUC Davis Comprehensive Cancer Center· Sacramento, CA

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