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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,

NCT03138499

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

Related Conditions:
  • Classical Hodgkin Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: 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: 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)

Clinical Trial IDs

  • ORG STUDY ID: CA209-812
  • SECONDARY ID: 2017-000847-41
  • NCT ID: NCT03138499

Conditions

  • Hodgkin's Disease

Interventions

DrugSynonymsArms
NivolumabOpdivoModule A
Brentuximab vedotinAdcetrisModule A

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Module AExperimentalNivolumab combined with Brentuximab
  • Nivolumab
  • Brentuximab vedotin
Module BExperimentalBrentuximab alone
  • Brentuximab vedotin

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:Up to four years
Safety Issue:
Description:To compare progression free survival of nivolumab + Brentuximab vedotin (BV) versus BV based on Blinded Independent Central Review (BICR) assessments

Secondary Outcome Measures

Measure:Complete Response Rate (CRR)
Time Frame:Up to four years
Safety Issue:
Description:To compare the complete response rate of nivolumab + BV versus BV based on BICR assessments
Measure:Objective Response Rate (ORR)
Time Frame:Up to four years
Safety Issue:
Description:To assess objective response rate and duration of response based on BICR
Measure:Duration of response (DOR)
Time Frame:Up to four years
Safety Issue:
Description:To assess duration of response based on BICR
Measure:Duration of complete response (DOCR)
Time Frame:Up to four years
Safety Issue:
Description:To assess duration of complete response based on BICR
Measure:Overall Survival (OS)
Time Frame:Up to four years
Safety Issue:
Description:To assess overall survival of participants treated with nivolumab + BV versus BV
Measure:Progression Free Survival (PFS)
Time Frame:Up to four years
Safety Issue:
Description:To assess PFS based on investigator assessments

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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