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,

Stopped early · Phase 3

Conditions studied: Hodgkin's Disease

In brief

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 facts

Study ID

NCT03138499

Run by

Bristol-Myers Squibb

People needed

23

Starts

2017-06-26

Expected to finish

2021-02-22

Last updated by the study team

2024-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Known central nervous system lymphoma.
• Participants with nodular lymphocyte-predominant Hodgkin lymphoma (HL).
• Participants with known history of pancreatitis or progressive multifocal leukoencephalopathy (PML).
• Other protocol-defined Inclusion/Exclusion criteria apply.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• University of Southern California — Los Angeles, California, United States
• UCLA Clinical and Translational Research Center (CTRC) — Los Angeles, California, United States
• Local Institution — Palo Alto, California, United States
• UC Davis Comprehensive Cancer Center — Sacramento, California, United States
• University of California San Diego — San Diego, California, United States
• Hartford Healthcare Cancer Institute at the Hospital of Central Connecticut — Plainville, Connecticut, United States
• Orlando Health, Inc — Orlando, Florida, United States
• Parkview Cancer Center — Fort Wayne, Indiana, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Dana Farber/Harvard Cancer Center — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Bon Secours Saint Francis Cancer Center — Greenville, South Carolina, United States
• Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• The University of Texas MD Anderson Cancer Center-merge — Houston, Texas, United States
• Local Institution — Sendai, Miyagi, Japan
• Local Institution — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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