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

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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

Nivolumab

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
  • Bristol-Myers Squibb

    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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03138499 on ClinicalTrials.gov