Nivolumab/Brentuximab Vedotin for Classical Hodgkin Lymphoma

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)

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Walton, Sherri

    Trial Phone: 321.841.1907

  • IRB No: 17.064.06

    Protocol Abbrev: CA209812

    Principal Investigator: Julio J. Hajdenberg, MD

    Sub Investigators: Landau, Daniel MD; Sarriera, Jose MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: CA209812

    Treatment: Medication

    Applicable Disease Sites: Classical Hodgkin Lymphoma

    Therapies Involved: Nivolumab combined with Brentuximab or Brentuximab alone

    ClinicalTrials.gov ID: NCT03138499

  • Objective

    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

  • Key Eligibility

    Ages Eligible for Study: 18 Years and older (Adult, Senior)
    Sexes Eligible for Study: All

    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