Spots Global Cancer Trial Database for A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma
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Trial Identification
Brief Title: A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma
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
Study ID: NCT02572167
Conditions
Study Description
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)
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
Stanford Cancer Center, Stanford, California, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Institute / Wayne State University, Detroit, Michigan, United States
Mayo Clinic Minnesota, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center - Commack, Commack, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
James Cancer Hospital / Ohio State University, Columbus, Ohio, United States
Charles A. Sammons Cancer Center / Baylor University Medical Center, Dallas, Texas, United States
Contact Details
Name: Faith Galderisi, DO
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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