Actively Recruiting
Brentuximab Vedotin and Nivolumab for the Treatment of Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
Led by City of Hope Medical Center · Updated on 2025-09-24
31
Participants Needed
5
Research Sites
255 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial investigates how well brentuximab vedotin and nivolumab work in treating patients with classical Hodgkin lymphoma that has come back after initial treatment (relapsed) or has not responded to initial treatment (refractory). Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Nivolumab is an antibody that enhances the immune system to better fight Hodgkin lymphoma cells. Giving brentuximab vedotin and nivolumab may be able to defer stem cell transplant treatment and spare the considerable cost and toxicity on transplantation.
CONDITIONS
Official Title
Brentuximab Vedotin and Nivolumab for the Treatment of Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent and assent when appropriate
- Willing to provide biopsy tissue obtained after frontline therapy and before study treatment
- ECOG performance status of 0, 1, or 2
- Histologically confirmed classical Hodgkin lymphoma (excluding nodular lymphocyte predominant subtype)
- Relapsed or refractory after no more than one prior therapy line (up to 5 patients with primary refractory disease allowed)
- Not eligible for autologous stem cell transplant due to age, health, or preference
- Measurable disease with at least one FDG-avid lesion 1.5 cm or larger
- Absolute neutrophil count at least 1,000/mm3
- Platelet count at least 50,000/mm3
- Hemoglobin level at least 8 g/dL
- Total or direct bilirubin no more than 1.5 times the upper limit of normal (ULN)
- AST and ALT no more than 2.5 times ULN
- Creatinine clearance at least 40 mL/min
- Women of childbearing potential with negative pregnancy test
- Agreement to use effective contraception or abstain during study and for specified months after last dose
You will not qualify if you...
- Receiving any other investigational therapy concurrently
- Received live vaccine within 30 days before starting treatment
- Grade 2 or higher peripheral neuropathy
- History of severe allergic reaction (grade 3 or higher) to brentuximab vedotin or nivolumab
- Active central nervous system lymphoma involvement
- History of another primary cancer not in remission for at least 3 years (with some exceptions)
- Need for systemic corticosteroids or immunosuppressive treatment within 14 days prior to study drug, with exceptions
- History of progressive multifocal leukoencephalopathy
- Known inherited or acquired immunodeficiency
- Active pneumonitis or interstitial lung disease
- Active or suspected autoimmune disease except certain controlled conditions
- Active hepatitis B or C infection or uncontrolled HIV infection
- Recent serious cardiovascular events within 6 months
- Pregnant or breastfeeding
- Any other condition that makes participation unsafe or impractical as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 5 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
Actively Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Hackensack University Medical Center/John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
5
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
A
Alex Herrera, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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