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



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/9/2019
Start Date:October 2015
End Date:December 2020

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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

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)

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.

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)
We found this trial at
13
sites
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Tatyana Feldman
Phone: 551-996-5168
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Ann LaCasce
Phone: 617-632-2328
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Columbus, Ohio 43210
Principal Investigator: Beth Christian
Phone: 614-293-2268
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Columbus, OH
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650 Commack Rd
Commack, New York 11725
(631) 623-4000
Principal Investigator: Alison Moskowitz
Phone: 212-639-2696
Memorial Sloan-Kettering Cancer Center at Commack Memorial Sloan Kettering Cancer Center - the world's oldest...
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Commack, NY
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Dallas, Texas 75246
Principal Investigator: Houston Holmes
Phone: 214-818-8382
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Dallas, TX
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Detroit, Michigan
Principal Investigator: Radhakrishnan Ramchandren
Phone: 313-576-9381
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Detroit, MI
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Alex Herrera
Phone: 626-218-3033
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Duarte, CA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Anne Beaven
Phone: 919-668-2556
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Alison Moskowitz
Phone: 212-639-2696
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Julie Vose
Phone: 402-559-5166
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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Rochester, Minnesota 55905
Principal Investigator: Stephen Ansell
Phone: 855-776-0015
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Rochester, MN
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Nancy Bartlett
Phone: 314-362-3021
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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Stanford, California 94305
Principal Investigator: Ranjana Advani
Phone: 650-721-4096
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