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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)

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ClinicalTrials.gov Identifier: NCT03138499
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : November 20, 2018
Sponsor:
Collaborators:
Seattle Genetics, Inc.
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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

Contacts and Locations
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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


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

  Show 69 Study Locations
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
More Information
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Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site Investigator Inquiry Form  This link exits the ClinicalTrials.gov site FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03138499     History of Changes
Other Study ID Numbers: CA209-812
2017-000847-41 ( EudraCT Number )
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018

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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