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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,

Trial Status: Closed to Accrual

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

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)

California

Duarte
City of Hope Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: APPROVED
Contact: Jodi Day
Phone: 310-825-1918
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Christine Duran
Phone: 323-865-0371
Sacramento
University of California Davis Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE
San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL

Florida

Tampa
Moffitt Cancer Center
Status: COMPLETED
Contact: Celeste Bello
Phone: 800-456-7121

Kansas

Kansas City
University of Kansas Cancer Center
Status: CLOSED_TO_ACCRUAL
University of Kansas Cancer Center-West
Status: ACTIVE
Overland Park
University of Kansas Cancer Center-Overland Park
Status: CLOSED_TO_ACCRUAL
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: CLOSED_TO_ACCRUAL

Massachusetts

Boston
Brigham and Women's Hospital
Status: CLOSED_TO_ACCRUAL
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL

Missouri

Kansas City
The University of Kansas Cancer Center-North
Status: CLOSED_TO_ACCRUAL
The University of Kansas Cancer Center-South
Status: CLOSED_TO_ACCRUAL
Lee's Summit
The University of Kansas Cancer Center-Lee's Summit
Status: ACTIVE

New York

Buffalo
Roswell Park Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE
Winston-Salem
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

South Carolina

Charleston
Medical University of South Carolina
Status: COMPLETED

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: CLOSED_TO_ACCRUAL

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Contact: Marcella West Aguilar
Phone: 214-648-1479
Houston
M D Anderson Cancer Center
Status: ACTIVE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

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