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

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.
 
ClinicalTrials.gov Identifier: NCT02572167
Recruitment Status : Completed
First Posted : October 8, 2015
Results First Posted : March 7, 2019
Last Update Posted : November 8, 2022
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Seagen Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: brentuximab vedotin Drug: nivolumab Phase 1 Phase 2

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 3 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 the safety and antitumor activity of brentuximab vedotin combined with nivolumab by enrolling patients at the recommended dose schedule determined in Part 1. Part 3 of the study will evaluate the safety and antitumor activity of combination treatment administered at an alternate dosing schedule determined by cumulative safety and activity data from Parts 1 and 2.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: N/A
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
Actual Study Start Date : October 31, 2015
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : October 21, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 28.9 months ]
    Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. The timeframe includes a 6.01 month safety reporting period and additional long-term follow up through 28.9 months.

  2. Complete Remission Rate [ Time Frame: Up to 3.42 months ]
    Number of patients with complete metabolic response (CMR) at end of treatment


Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Up to 3.42 months ]
    Number of patients with complete metabolic response (CMR) or partial metabolic response (PMR)

  2. Duration of Complete Response [ Time Frame: Up to 69.3 months ]
    The time from start of the first documentation of complete response (CR) to the first documentation of tumor progression (PD) including radiographic evidence of progression and clinical progression per investigator or to death due to any cause, whichever comes first.

  3. Duration of Objective Response [ Time Frame: Up to 69.3 months ]
    The time from start of the first documentation of OR (CR or PR) to the first documentation of PD or to death due to any cause, whichever comes first.

  4. Progression-free Survival Post-autologous Stem Cell Transplant [ Time Frame: Up to 67.3 months ]
    For participants who undergo ASCT, the time from ASCT to the first documentation of PD or to death due to any cause, whichever comes first.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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
Seagen Inc.
Bristol-Myers Squibb
Investigators
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Study Director: Faith Galderisi, DO Seagen Inc.
  Study Documents (Full-Text)

Documents provided by Seagen Inc.:
Study Protocol  [PDF] January 23, 2017
Statistical Analysis Plan  [PDF] August 9, 2017

More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT02572167    
Other Study ID Numbers: SGN35-025
First Posted: October 8, 2015    Key Record Dates
Results First Posted: March 7, 2019
Last Update Posted: November 8, 2022
Last Verified: October 2022
Keywords provided by Seagen Inc.:
Monomethyl auristatin E
Antigens, CD30
Antibody-Drug Conjugate
 Antibodies, Monoclonal
Immunotherapy
Autologous stem cell transplant
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Nivolumab
Brentuximab Vedotin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action