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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Module A
Nivolumab combined with Brentuximab
  • Biological: Nivolumab
    Specified dose on specified days
    Other names:
    • Opdivo
  • Biological: Brentuximab vedotin
    Specified dose on specified days
    Other names:
    • Adcetris
Experimental
Module B
Brentuximab alone
  • Biological: Brentuximab vedotin
    Specified dose on specified days
    Other names:
    • Adcetris

More Details

Status
Terminated
Sponsor
Bristol-Myers Squibb

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.