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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

Tracking Information
First Submitted Date  ICMJE May 1, 2017
First Posted Date  ICMJE May 3, 2017
Last Update Posted Date October 28, 2019
Actual Study Start Date  ICMJE May 16, 2017
Estimated Primary Completion Date November 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03138499 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2017)
  • 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
  • Objective Response Rate (ORR) [ Time Frame: Up to four years ]
    To assess objective response rate and duration of response based on BICR
  • Duration of response (DOR) [ Time Frame: Up to four years ]
    To assess duration of response based on BICR
  • Duration of complete response (DOCR) [ Time Frame: Up to four years ]
    To assess duration of complete response based on BICR
  • Overall Survival (OS) [ Time Frame: Up to four years ]
    To assess overall survival of participants treated with nivolumab + BV versus BV
  • Progression Free Survival (PFS) [ Time Frame: Up to four years ]
    To assess PFS based on investigator assessments
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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,
Official Title  ICMJE 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)
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hodgkin's Disease
Intervention  ICMJE
  • Biological: Nivolumab
    Specified dose on specified days
    Other Name: Opdivo
  • Biological: Brentuximab vedotin
    Specified dose on specified days
    Other Name: Adcetris
Study Arms  ICMJE
  • Experimental: Module A
    Nivolumab combined with Brentuximab
    Interventions:
    • Biological: Nivolumab
    • Biological: Brentuximab vedotin
  • Experimental: Module B
    Brentuximab alone
    Intervention: Biological: Brentuximab vedotin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 1, 2017)
340
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 27, 2023
Estimated Primary Completion Date November 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Puerto Rico,   United States
Removed Location Countries Australia,   Czechia,   Hungary,   Italy,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT03138499
Other Study ID Numbers  ICMJE CA209-812
2017-000847-41 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE
  • Seattle Genetics, Inc.
  • Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP