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A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02572167
First Posted: October 8, 2015
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Seattle Genetics, Inc.
  Purpose
The purpose of this study is to assess the safety profile and antitumor activity of brentuximab vedotin administered in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma (HL)

Condition Intervention Phase
Hodgkin Lymphoma Drug: brentuximab vedotin Drug: nivolumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study Evaluating Brentuximab Vedotin in Combination With Nivolumab in Patients With Relapsed or Refractory Hodgkin Lymphoma After Failure of Frontline Therapy

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Up to 7 months ]
  • Complete response rate [ Time Frame: Up to 5 months ]

Secondary Outcome Measures:
  • Objective response rate [ Time Frame: Up to 5 months ]
  • Duration of complete response [ Time Frame: Up to approximately 3 years ]
  • Duration of objective response [ Time Frame: Up to approximately 3 years ]
  • Progression-free survival post-autologous stem cell transplant [ Time Frame: Up to approximately 3 years ]

Enrollment: 93
Study Start Date: October 2015
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brentuximab Vedotin + Nivolumab
Brentuximab vedotin plus nivolumab
Drug: brentuximab vedotin
1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles
Other Name: SGN-35, ADCETRIS
Drug: nivolumab
3 mg/kg by intravenous (IV) infusion for up to 4 cycles
Other Name: BMS-936558, OPDIVO

Detailed Description:

This study will examine the safety profile and antitumor activity when brentuximab vedotin is combined with nivolumab. Patients will be treated for up to four 21-day cycles with brentuximab vedotin 1.8 mg/kg and nivolumab 3 mg/kg.

There will be 2 parts to this study. In Part 1, the safety of combination treatment will be evaluated by a Safety Monitoring Committee (SMC) prior to expansion of enrollment to evaluate treatment effect in Part 2. Part 2 of the study will further characterize safety and evaluate the antitumor activity of brentuximab vedotin combined with nivolumab by enrolling patients at the recommended dose schedule determined in Part 1.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relapsed or refractory Hodgkin lymphoma following failure of standard frontline chemotherapy for the treatment of classical Hodgkin lymphoma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Previously treated with brentuximab vedotin, immune-oncology agents, or received an allogeneic or autologous stem cell transplant
  • Documented history of a cerebral vascular event
  • History of another invasive malignancy that has not been in remission for at least 3 years
  • History of progressive multifocal leukoencephalopathy (PML)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572167


Locations
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
Stanford Cancer Center
Stanford, California, United States, 94305
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Memorial Sloan Kettering Cancer Center - Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
James Cancer Hospital / Ohio State University
Columbus, Ohio, United States, 43210
United States, Texas
Charles A. Sammons Cancer Center / Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Seattle Genetics, Inc.
Bristol-Myers Squibb
Investigators
Study Director: Faith Galderisi, DO Seattle Genetics, Inc.
  More Information

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02572167     History of Changes
Other Study ID Numbers: SGN35-025
First Submitted: October 7, 2015
First Posted: October 8, 2015
Last Update Posted: October 20, 2017
Last Verified: October 2017

Keywords provided by Seattle Genetics, Inc.:
Monomethyl auristatin E
Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Immunotherapy
Autologous stem cell transplant

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Antibodies, Monoclonal
Nivolumab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents