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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Seattle Genetics, Inc.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT02572167
First received: October 7, 2015
Last updated: June 28, 2017
Last verified: June 2017
  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: No masking
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 ]

Estimated Enrollment: 92
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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02572167

Contacts
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Jaemee Bautista    626-218-3033    jbautista@coh.org   
Principal Investigator: Alex Herrera         
Stanford Cancer Center Recruiting
Stanford, California, United States, 94305
Contact: Ann Moffat    650-721-4096    amoffat@stanford.edu   
Contact: Sipra Choudhury    650-736-2563    schoudhury@stanford.edu   
Principal Investigator: Ranjana Advani         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Ashley Newcomb    617-632-2328    AshleyN_Newcomb@DFCI.Harvard.Edu   
Contact: Sara Schlegel    617-632-6840    sschlegel@partners.org   
Principal Investigator: Ann LaCasce         
United States, Michigan
Karmanos Cancer Institute / Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Christiane Houde    313-576-9381    houdec@karmanos.org   
Principal Investigator: Radhakrishnan Ramchandren         
United States, Minnesota
Mayo Clinic Minnesota Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mayo Clinic Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Stephen Ansell         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Anne Fischer    314-362-3021    afischer@dom.wustl.edu   
Contact: Kelly Hoye    314-362-4206    khoye@wustl.edu   
Principal Investigator: Nancy Bartlett         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-7680
Contact: Julie Vose    402-559-5166    jmvose@unmc.edu   
Contact: Maribeth Hohenstein    402-559-9053    mahohens@unmc.edu   
Principal Investigator: Julie Vose         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Kara Yannotti    551-996-5168    Kara.Yannotti@HackensackMeridian.org   
Principal Investigator: Tatyana Feldman         
United States, New York
Memorial Sloan Kettering Cancer Center - Commack Recruiting
Commack, New York, United States, 11725
Contact: Alison Moskowitz    212-639-2696    moskowia@mskcc.org   
Principal Investigator: Alison Moskowitz         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Alison Moskowitz    212-639-2696    moskowia@mskcc.org   
Principal Investigator: Alison Moskowitz         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Jean Shearin    919-668-2556    sherra.shearin@duke.edu   
Contact: Stacy Murray    919-668-1211    stacy.murray@duke.edu   
Principal Investigator: Anne Beaven         
United States, Ohio
James Cancer Hospital / Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Beth Christian    614-293-2268    Beth.Christian@osumc.edu   
Principal Investigator: Beth Christian         
United States, Texas
Charles A. Sammons Cancer Center / Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Grace Townsend    214-818-8382    grace.townsend@bswhealth.org   
Principal Investigator: Houston Holmes         
Sponsors and Collaborators
Seattle Genetics, Inc.
Bristol-Myers Squibb
Investigators
Study Director: Mary Campbell, MD Seattle Genetics, Inc.
  More Information

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02572167     History of Changes
Other Study ID Numbers: SGN35-025
Study First Received: October 7, 2015
Last Updated: June 28, 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

ClinicalTrials.gov processed this record on July 27, 2017