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,

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

Study Start Date

May, 16 2017

Estimated Completion Date

July 2023

Interventions

  • Biological: Brentuximab vedotin
  • Biological: Nivolumab

Study ID

Bristol-Myers Squibb -- CA209-812

Status

Recruiting

Trial ID

NCT03138499

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

340

Sponsor

Bristol-Myers Squibb

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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) Other protocol defined inclusion/exclusion criteria could apply

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (130)

Study Location Distance Name Phone Email
Dana Farber Cancer Institute DFCI - Boston, Massachusetts 2.4 miles Philippe Armand Site 0011 None None
Dana Farber Cancer Institute DFCI - Boston, Massachusetts 2.4 miles Philippe Armand Site 0011 None None
Dana Farber Cancer Institute DFCI - Boston, Massachusetts 2.4 miles Philippe Armand Site 0011 None None
Cancer Center of Central Connecticut - Southington, Connecticut 105.2 miles Peter Byeff Site 0032 None None
Cancer Center of Central Connecticut - Southington, Connecticut 105.2 miles Peter Byeff Site 0032 None None
Cancer Center of Central Connecticut - Southington, Connecticut 105.2 miles Peter Byeff Site 0032 None None
John Theurer Cancer Center Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles Tatyana Feldman Site 0036 551-996-5168 None
John Theurer Cancer Center Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles Tatyana Feldman Site 0036 551-996-5168 None
John Theurer Cancer Center Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles Tatyana Feldman Site 0036 551-996-5168 None
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Jakub Svoboda Site 0008 267-216-7131 None
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Jakub Svoboda Site 0008 267-216-7131 None
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Jakub Svoboda Site 0008 267-216-7131 None
Georgetown University Hospital - Washington, District of Columbia 394.4 miles Bruce Cheson Site 0050 202-687-7354 None
Georgetown University Hospital - Washington, District of Columbia 394.4 miles Bruce Cheson Site 0050 202-687-7354 None
Georgetown University Hospital - Washington, District of Columbia 394.4 miles Bruce Cheson Site 0050 202-687-7354 None
Bon Secours Saint Francis Cancer Center - Greenville, South Carolina 800.4 miles Sharif Khan Site 0001 864-603-6222 None
Bon Secours Saint Francis Cancer Center - Greenville, South Carolina 800.4 miles Sharif Khan Site 0001 864-603-6222 None
Bon Secours Saint Francis Cancer Center - Greenville, South Carolina 800.4 miles Sharif Khan Site 0001 864-603-6222 None
UT Medical Center Cancer Institute - Knoxville, Tennessee 817.2 miles Wahid Hanna Site 0042 865-541-1812 None
UT Medical Center Cancer Institute - Knoxville, Tennessee 817.2 miles Wahid Hanna Site 0042 865-541-1812 None
UT Medical Center Cancer Institute - Knoxville, Tennessee 817.2 miles Wahid Hanna Site 0042 865-541-1812 None
Center For Biomedical Research - Knoxville, Tennessee 822.5 miles Tracy Dobbs Site 0052 865-934-2670 None
Center For Biomedical Research - Knoxville, Tennessee 822.5 miles Tracy Dobbs Site 0052 865-934-2670 None
Center For Biomedical Research - Knoxville, Tennessee 822.5 miles Tracy Dobbs Site 0052 865-934-2670 None
Louisville Oncology - Louisville, Kentucky 823.2 miles Don Stevens Site 0015 502-899-6147 None
Louisville Oncology - Louisville, Kentucky 823.2 miles Don Stevens Site 0015 502-899-6147 None
Louisville Oncology - Louisville, Kentucky 823.2 miles Don Stevens Site 0015 502-899-6147 None
UF Health Cancer Center Orlando Health - Orlando, Florida 1,118.6 miles Julio Hajdenberg Site 0044 None None
UF Health Cancer Center Orlando Health - Orlando, Florida 1,118.6 miles Julio Hajdenberg Site 0044 None None
UF Health Cancer Center Orlando Health - Orlando, Florida 1,118.6 miles Julio Hajdenberg Site 0044 None None
Mercy Medical Research Institute - Springfield, Missouri 1,228.8 miles Rajesh Nair Site 0045 417-820-9742 None
Mercy Medical Research Institute - Springfield, Missouri 1,228.8 miles Rajesh Nair Site 0045 417-820-9742 None
Mercy Medical Research Institute - Springfield, Missouri 1,228.8 miles Rajesh Nair Site 0045 417-820-9742 None
Usa Mitchell Cancer Institute - Mobile, Alabama 1,248.6 miles Thaddeus Beeker Site 0059 251-445-8427 None
Usa Mitchell Cancer Institute - Mobile, Alabama 1,248.6 miles Thaddeus Beeker Site 0059 251-445-8427 None
Usa Mitchell Cancer Institute - Mobile, Alabama 1,248.6 miles Thaddeus Beeker Site 0059 251-445-8427 None
Mercy Clinic Oncology and Hematology Joplin - Joplin, Missouri 1,295.4 miles Samir Dalia Site 0053 417-556-3074 None
Mercy Clinic Oncology and Hematology Joplin - Joplin, Missouri 1,295.4 miles Samir Dalia Site 0053 417-556-3074 None
Mercy Clinic Oncology and Hematology Joplin - Joplin, Missouri 1,295.4 miles Samir Dalia Site 0053 417-556-3074 None
Vista Oncology East Olympia - Olympia, Washington 2,527.2 miles Joseph Ye Site 0057 None None
Vista Oncology East Olympia - Olympia, Washington 2,527.2 miles Joseph Ye Site 0057 None None
Vista Oncology East Olympia - Olympia, Washington 2,527.2 miles Joseph Ye Site 0057 None None
City of Hope National Medical Center - Duarte, California 2,578.2 miles Alex Herrera Site 0002 626-218-9108 None
City of Hope National Medical Center - Duarte, California 2,578.2 miles Alex Herrera Site 0002 626-218-9108 None
City of Hope National Medical Center - Duarte, California 2,578.2 miles Alex Herrera Site 0002 626-218-9108 None
Local Institution - La Jolla, California 2,581.5 miles Site 0006 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0007 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0038 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0005 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0013 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0037 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0003 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0004 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0034 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0041 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0035 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0031 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0033 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0010 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0039 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0040 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0009 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0017 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0019 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0016 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0018 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0020 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0027 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0024 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0021 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0075 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0076 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0074 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0023 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0006 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0012 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0038 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0005 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0013 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0037 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0003 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0004 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0034 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0041 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0035 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0031 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0033 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0039 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0040 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0009 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0017 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0019 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0016 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0018 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0020 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0027 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0024 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0022 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0021 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0075 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0076 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0074 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0023 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0025 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0006 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0012 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0038 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0005 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0003 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0004 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0034 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0041 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0035 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0031 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0010 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0009 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0017 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0016 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0027 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0024 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0022 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0021 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0075 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0076 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0074 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0023 None None
Local Institution - La Jolla, California 2,581.5 miles Site 0025 None None
Pacific Shores Medical Group - Long Beach, California 2,595.4 miles Kiem Liem Site 0014 562-590-0345 None
Pacific Shores Medical Group - Long Beach, California 2,595.4 miles Kiem Liem Site 0014 562-590-0345 None
Pacific Shores Medical Group - Long Beach, California 2,595.4 miles Kiem Liem Site 0014 562-590-0345 None

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