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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, (CheckMate 812)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03138499
Recruitment Status : Active, not recruiting
First Posted : May 3, 2017
Last Update Posted : October 28, 2019
Sponsor:
Collaborators:
Seattle Genetics, Inc.
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Hodgkin's Disease Biological: Nivolumab Biological: Brentuximab vedotin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open-label, Phase 3 Trial of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Participants With Relapsed Refractory or Ineligible for Autologous Stem Cell Transplant (ASCT) Advanced Stage Classical Hodgkin Lymphoma (CheckMate 812: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 812)
Actual Study Start Date : May 16, 2017
Estimated Primary Completion Date : November 29, 2020
Estimated Study Completion Date : July 27, 2023


Arm Intervention/treatment
Experimental: Module A
Nivolumab combined with Brentuximab
Biological: Nivolumab
Specified dose on specified days
Other Name: Opdivo

Biological: Brentuximab vedotin
Specified dose on specified days
Other Name: Adcetris

Experimental: Module B
Brentuximab alone
Biological: Brentuximab vedotin
Specified dose on specified days
Other Name: Adcetris




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Up to four years ]
    To compare progression free survival of nivolumab + Brentuximab vedotin (BV) versus BV based on Blinded Independent Central Review (BICR) assessments


Secondary Outcome Measures :
  1. Complete Response Rate (CRR) [ Time Frame: Up to four years ]
    To compare the complete response rate of nivolumab + BV versus BV based on BICR assessments

  2. Objective Response Rate (ORR) [ Time Frame: Up to four years ]
    To assess objective response rate and duration of response based on BICR

  3. Duration of response (DOR) [ Time Frame: Up to four years ]
    To assess duration of response based on BICR

  4. Duration of complete response (DOCR) [ Time Frame: Up to four years ]
    To assess duration of complete response based on BICR

  5. Overall Survival (OS) [ Time Frame: Up to four years ]
    To assess overall survival of participants treated with nivolumab + BV versus BV

  6. Progression Free Survival (PFS) [ Time Frame: Up to four years ]
    To assess PFS based on investigator assessments



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138499


Locations
Hide Hide 60 study locations
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United States, Alabama
Dr. Moh'd Khushman MD, Office of
Mobile, Alabama, United States, 36604
United States, Arkansas
University Of Arkansas For Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
Tori - Pacific Shores Medical Group
Long Beach, California, United States, 90813
University of Southern California
Los Angeles, California, United States, 90033
UCLA Clinical and Translational Research Center (CTRC)
Los Angeles, California, United States, 90095
Local Institution
Palo Alto, California, United States, 94304
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
University of California San Diego
San Diego, California, United States, 92122
United States, Connecticut
Hartford Healthcare Cancer Institute at The Hospital of Central Connecticut
Plainville, Connecticut, United States, 06062
United States, District of Columbia
MedStar Georgetown University Hospital (MGUH)
Washington, District of Columbia, United States, 20007
United States, Florida
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Miami Cancer Institute, Baptist Health South Florida
Miami, Florida, United States, 33176
Orlando Health, Inc
Orlando, Florida, United States, 32806
H. Lee Moffit Cancer center and research institute
Tampa, Florida, United States, 33612
United States, Indiana
Parkview Cancer Center
Fort Wayne, Indiana, United States, 46845
United States, Kansas
University of Kansas Hospital
Westwood, Kansas, United States, 66205
United States, Kentucky
Louisville Oncology
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Dana Farber/Harvard Cancer Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Missouri
Mercy Clinic Oncology and Hematology - Joplin
Joplin, Missouri, United States, 64804
Mercy Medical Research Institute
Springfield, Missouri, United States, 65804
United States, New Jersey
Memorial Sloan-Kettering Cancer Center (MSKCC) - Basking Ridge
Basking Ridge, New Jersey, United States, 07920
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Memorial Sloan Kettering Cancer Center Monmouth
Middletown, New Jersey, United States, 07748
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Memorial Sloan Kettering Cancer Center
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Local Institution
Rochester, New York, United States, 14642
Memorial Sloan Kettering Cancer Center Rockville Centre
Rockville Centre, New York, United States, 11570
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27110
East Carolina University Brody School of Medicine(ECU)
Greenville, North Carolina, United States, 27834
Local Institution
Raleigh, North Carolina, United States, 27607
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Local Institution
Philadelphia, Pennsylvania, United States, 19111-2497
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Bon Secours Saint Francis Cancer Center
Greenville, South Carolina, United States, 29607
Greenville Health System Cancer Institute
Spartanburg, South Carolina, United States, 29307
United States, Tennessee
Center For Biomedical Research
Knoxville, Tennessee, United States, 37909
UT Medical Center Cancer Institute
Knoxville, Tennessee, United States, 37920
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37213
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Local Institution
San Antonio, Texas, United States, 78229
United States, Virginia
Local Institution
Charlottesville, Virginia, United States, 22908
United States, Washington
Vista Oncology - East Olympia
Olympia, Washington, United States, 98502
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Japan
Local Institution
Nagoya-shi, Aichi, Japan, 4600001
Local Institution
Nagoya, Aichi, Japan, 4648681
Local Institution
Fukuoka-shi, Fukuoka, Japan, 8128582
Local Institution
Isehara, Kanagawa, Japan, 2591193
Local Institution
Sendai-shi, Miyagi, Japan, 9808574
Local Institution
Osakasayaha, Osaka, Japan, 5898511
Local Institution
Chuo-ku, Tokyo, Japan, 1040045
Local Institution
Koto-ku, Tokyo, Japan, 135-8550
Puerto Rico
Local Institution
San Juan, Puerto Rico, 00918
Sponsors and Collaborators
Bristol-Myers Squibb
Seattle Genetics, Inc.
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03138499    
Other Study ID Numbers: CA209-812
2017-000847-41 ( EudraCT Number )
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs