Actively Recruiting
Brentuximab Vedotin and Nivolumab for the Treatment of Relapsed/Refractory Classic Hodgkin Lymphoma Previously Treated With Brentuximab Vedotin or Checkpoint Inhibitors
Led by Emory University · Updated on 2025-08-22
46
Participants Needed
2
Research Sites
291 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies the effect of brentuximab vedotin and nivolumab in treating patients with classic Hodgkin lymphoma that has come back (relapsed) or does not respond to treatment (refractory) that have been previously treated with brentuximab vedotin or checkpoint inhibitors. 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. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving brentuximab vedotin and nivolumab in combination may be an effective treatment in patients with relapsed or refractory classic Hodgkin lymphoma previously treated with brentuximab vedotin or checkpoint inhibitors.
CONDITIONS
Official Title
Brentuximab Vedotin and Nivolumab for the Treatment of Relapsed/Refractory Classic Hodgkin Lymphoma Previously Treated With Brentuximab Vedotin or Checkpoint Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed classical Hodgkin lymphoma
- 12 years of age or older
- Received 1-2 prior multi-agent chemotherapy or immunotherapy regimens
- Cohort A: Only one prior brentuximab-containing regimen with no prior checkpoint inhibitors
- Cohort B: Only one prior checkpoint inhibitor-containing regimen with no prior brentuximab
- Radiation as part of front-line treatment counts as one prior therapy
- No prior autologous or allogeneic transplant
- ECOG performance status \u2264 2 for patients over 18 or Lansky performance \u2265 50 for ages 12-18
- Measurable disease with tumor or nodal mass > 1.5 cm in one dimension
- Resolution of prior toxicities to grade \u2264 1
- Absolute neutrophil count \u2265 750 (unless disease related) within 28 days of cycle 1 day 1
- Platelets \u2265 50,000 (unless disease related) within 28 days of cycle 1 day 1
- Creatinine \u2264 upper limit of normal within 28 days of cycle 1 day 1
- AST/ALT \u2264 3 x upper limit of normal within 28 days of cycle 1 day 1
- Bilirubin \u2264 2 mg/dL within 28 days of cycle 1 day 1
- HIV patients allowed if no hepatitis B or C co-infection, CD4+ \u2265 400/mm, no resistant HIV, on anti-HIV therapy with viral load < 50 copies/mL, and recent infectious disease follow-up
- Females of child-bearing potential must have negative pregnancy test before therapy
- Agree to use contraception during and 6 months after study participation
- Completion of prior cancer therapy at least 2 weeks before study start
- Cardiac function class 2B or better by NYHA classification if history of cardiac disease
- Willingness and ability to comply with study procedures
- Signed informed consent or parental consent and assent for ages 12-17
You will not qualify if you...
- Prior malignancy except certain treated skin or cervical cancers disease-free for \u2265 2 years or not limiting survival
- Chemotherapy or radiotherapy within 2 weeks before study entry or unresolved adverse events > grade 1
- Active or history of autoimmune disease such as hepatitis, hypophysitis, nephritis, lung disease, colitis
- Active central nervous system lymphoma involvement
- Positive for hepatitis B or hepatitis C infection
- Active infection or illness including symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
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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