A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma
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
1 other identifier
interventional
93
1 country
13
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2015
Longer than P75 for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2015
CompletedFirst Posted
Study publicly available on registry
October 8, 2015
CompletedStudy Start
First participant enrolled
October 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedResults Posted
Study results publicly available
March 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2021
CompletedNovember 8, 2022
October 1, 2022
2.3 years
October 7, 2015
February 13, 2019
October 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Adverse Events (AEs)
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.
Up to 28.9 months
Complete Remission Rate
Number of patients with complete metabolic response (CMR) at end of treatment
Up to 3.42 months
Secondary Outcomes (4)
Objective Response Rate
Up to 3.42 months
Duration of Complete Response
Up to 69.3 months
Duration of Objective Response
Up to 69.3 months
Progression-free Survival Post-autologous Stem Cell Transplant
Up to 67.3 months
Study Arms (1)
Brentuximab Vedotin + Nivolumab
EXPERIMENTALBrentuximab vedotin plus nivolumab
Interventions
1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles
3 mg/kg by intravenous (IV) infusion for up to 4 cycles
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
- Bristol-Myers Squibbcollaborator
Study Sites (13)
City of Hope National Medical Center
Duarte, California, 91010-3000, 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
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680, 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
Related Publications (2)
Herrera AF, Moskowitz AJ, Bartlett NL, Vose JM, Ramchandren R, Feldman TA, LaCasce AS, Ansell SM, Moskowitz CH, Fenton K, Ogden CA, Taft D, Zhang Q, Kato K, Campbell M, Advani RH. Interim results of brentuximab vedotin in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2018 Mar 15;131(11):1183-1194. doi: 10.1182/blood-2017-10-811224. Epub 2017 Dec 11.
PMID: 29229594RESULTAdvani RH, Moskowitz AJ, Bartlett NL, Vose JM, Ramchandren R, Feldman TA, LaCasce AS, Christian BA, Ansell SM, Moskowitz CH, Brown L, Zhang C, Taft D, Ansari S, Sacchi M, Ho L, Herrera AF. Brentuximab vedotin in combination with nivolumab in relapsed or refractory Hodgkin lymphoma: 3-year study results. Blood. 2021 Aug 12;138(6):427-438. doi: 10.1182/blood.2020009178.
PMID: 33827139DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Seagen Inc.
Study Officials
- STUDY DIRECTOR
Faith Galderisi, DO
Seagen Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2015
First Posted
October 8, 2015
Study Start
October 31, 2015
Primary Completion
March 1, 2018
Study Completion
October 21, 2021
Last Updated
November 8, 2022
Results First Posted
March 7, 2019
Record last verified: 2022-10