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,

Status: Active

Description

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

Eligibility Criteria

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Participants must have a pathologic diagnosis of classical Hodgkin lymphoma (cHL) who are relapsed or refractory with one of the following: I. Autologous stem cell transplant (ASCT) ineligible patients ii. Patients after failure of ASCT
  • Must have at least one lesion that is > 15 mm (1.5 cm) in the longest diameter and avid by Fluoro Deoxy Glucose (FDG) Positron Emission Tomography (PET) scan

Exclusion Criteria

  • Known central nervous system lymphoma
  • Participants with nodular lymphocyte-predominant Hodgkin lymphoma (HL)
  • Participants with known history of pancreatitis or progressive multifocal leukoencephalopathy (PML)

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Approved
Contact: Jodi Day
Phone: 310-825-1918
Email: JMDay@mednet.ucla.edu
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Christine Duran
Phone: 323-865-0371
Email: Duran_C@med.usc.edu
San Diego
University of California San Diego
Status: Active
Name Not Available

Florida

Tampa
Moffitt Cancer Center
Status: Active
Contact: Celeste Bello
Phone: 800-456-7121
Email: canceranswers@moffitt.org

Kansas

Kansas City
University of Kansas Cancer Center-West
Status: Active
Name Not Available

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: Active
Name Not Available

Missouri

Lee's Summit
The University of Kansas Cancer Center-Lee's Summit
Status: Active
Name Not Available

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

North Carolina

Durham
Duke University Medical Center
Status: Active
Name Not Available
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Name Not Available

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Name Not Available

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Name Not Available

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Marcella West Aguilar
Phone: 214-648-1479
Email: marcella.aguilar@utsouthwestern.edu
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Bristol-Myers Squibb

Trial IDs

Primary ID CA209-812
Secondary IDs NCI-2017-01275, 2017-000847-41
Clinicaltrials.gov ID NCT03138499