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 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2024-01-10
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
Conditions
- Hodgkin's Disease
Interventions
- BIOLOGICAL
-
Specified dose on specified days
- BIOLOGICAL
-
Brentuximab vedotin
Specified dose on specified days
Sponsors & Collaborators
-
Seagen Inc.
collaborator INDUSTRY -
Ono Pharmaceutical Co. Ltd
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-06-26
- Primary Completion
- 2021-02-22
- Completion
- 2021-02-22
- FDA Drug
- Yes
Countries
- United States
- Japan
- Puerto Rico
Study Locations
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