Non Hodgkin Lymphoma Clinical Trial

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

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)

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Full 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.

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Eligibility 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)

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

93

Study ID:

NCT02572167

Recruitment Status:

Completed

Sponsor:

Seagen Inc.

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There are 13 Locations for this study

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City of Hope National Medical Center
Duarte California, 91010, United States
Stanford Cancer Center
Stanford California, 94305, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Karmanos Cancer Institute / Wayne State University
Detroit Michigan, 48201, United States
Mayo Clinic Minnesota
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Memorial Sloan Kettering Cancer Center - Commack
Commack New York, 11725, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10021, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
James Cancer Hospital / Ohio State University
Columbus Ohio, 43210, United States
Charles A. Sammons Cancer Center / Baylor University Medical Center
Dallas Texas, 75246, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

93

Study ID:

NCT02572167

Recruitment Status:

Completed

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

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