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Monoclonal Antibodies

Brentuximab Vedotin + Nivolumab for Hodgkin's Lymphoma

Phase 2
Recruiting
Led By Jason T Romancik, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be 12 years of age or older
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 for patients > 18 years old, or Lansky performance status of >= 50 for patients ages 12-18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying the combination of brentuximab vedotin and nivolumab to see how well it works in treating patients with classic Hodgkin lymphoma that has come back or does not respond to previous treatment with brentuximab vedotin or checkpoint inhibitors.

Who is the study for?
This trial is for patients aged 12 or older with classic Hodgkin lymphoma that has relapsed or is refractory after treatment with brentuximab vedotin or checkpoint inhibitors. Participants must have measurable disease, acceptable organ function, and no prior transplants. HIV-positive patients can join if well-managed. Women of childbearing age must test negative for pregnancy and agree to contraception.Check my eligibility
What is being tested?
The phase II trial tests the combination of brentuximab vedotin (an antibody-drug conjugate) and nivolumab (a monoclonal antibody immunotherapy) in treating relapsed/refractory classic Hodgkin lymphoma previously treated with either agent but not both. The study aims to see how effective this combo is in such cases.See study design
What are the potential side effects?
Potential side effects include immune-related reactions like inflammation in various organs, infusion reactions from the drug administration process, fatigue, blood disorders which may affect cell counts, increased risk of infections due to immune system suppression, and possible liver enzyme elevations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 12 years old or older.
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I am over 18 and can care for myself, or I am 12-18 with moderate activity levels.
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I am a woman who can have children and have a negative pregnancy test.
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I have undergone 1-2 rounds of chemotherapy or immunotherapy.
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I have a tumor or swollen lymph node larger than 1.5 cm.
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My diagnosis is classical Hodgkin lymphoma.
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I have not had a stem cell transplant from myself or a donor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Complete response rate (CRR)
Incidence of adverse events
Incidence of symptomatic toxicity
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (brentuximab vedotin, nivolumab)Experimental Treatment5 Interventions
Patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response or partial response at any time after 4 cycles may discontinue study therapy to proceed to autologous or allogeneic stem cell transplant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~360
Nivolumab
2014
Completed Phase 3
~4750
Brentuximab Vedotin
2015
Completed Phase 4
~1100

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,639 Previous Clinical Trials
2,560,600 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,959 Total Patients Enrolled
Jason T Romancik, MDPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute

Media Library

Brentuximab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05039073 — Phase 2
Hodgkin's Lymphoma Research Study Groups: Treatment (brentuximab vedotin, nivolumab)
Hodgkin's Lymphoma Clinical Trial 2023: Brentuximab Vedotin Highlights & Side Effects. Trial Name: NCT05039073 — Phase 2
Brentuximab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05039073 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA sanction Brentuximab Vedotin?

"Brentuximab Vedotin, while not yet having received support for efficacy in clinical trials, has been deemed safe enough to warrant a score of 2."

Answered by AI

Which medical condition does Brentuximab Vedotin usually help alleviate?

"Brentuximab Vedotin can be used as an cancer treatment for patients suffering from malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

Is Brentuximab Vedotin a new or experimental drug?

"Brentuximab Vedotin is being researched in 797 different clinical trials, 88 of which are currently active. Most Brentuximab Vedotin studies are based in Basel, BE, but there are a total of 41362 locations running research for this treatment globally."

Answered by AI

Are there any current vacancies for people who wish to participate in this trial?

"The information available on clinicaltrials.gov implies that this trial is still searching for patients. This study was originally advertised on May 2nd, 2020 and has since been updated June 1st, 2020. So far, 46 people have signed up at the two primary locations."

Answered by AI

How many people are being asked to participate in this clinical trial?

"The information available on clinicaltrials.gov verifies that this trial is actively recruiting patients. The 46 participants needed for the study will be recruited from 2 sites, with the first posting occurring on May 2nd, 2022 and the most recent update being June 1st, 2022."

Answered by AI

What other research exists on this topic?

"There are 797 ongoing studies involving Brentuximab Vedotin in 2463 cities and 53 countries. The very first trial was held a decade ago in 2010 and, sponsored by Medarex, it included 127 patients who completed Phase 1 drug approval. In the 10 years since then, 534 similar studies have been completed."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Brentuximab Vedotin and Nivolumab for the Treatment of Relapsed/Refractory Classic Hodgkin Lymphoma Previously Treated With Brentuximab Vedotin or Checkpoint Inhibitors
Jason Romancik 2022. "Brentuximab Vedotin and Nivolumab for the Treatment of Relapsed/Refractory Classic Hodgkin Lymphoma Previously Treated With Brentuximab Vedotin or Checkpoint Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05039073.
~26 spots leftby Nov 2026
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