← Back to Search

Monoclonal Antibodies

Brentuximab + Nivolumab for Hodgkin's Lymphoma

Phase 2
Waitlist Available
Led By Alex F Herrera
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have prior to standard of care ABVD treatment at least one lesion that is > 1.5 cm in the longest diameter on cross-sectional imaging and measureable in two perpendicular dimensions on CT and fludeoxyglucose (FDG) avid by PET
Stage IA, IB, IIA, or IIB cHL by Cotswold modified Ann Arbor staging done prior to any treatment with ABVD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing brentuximab vedotin and nivolumab to see if they work well in treating patients with early-stage Hodgkin lymphoma.

Who is the study for?
This trial is for patients with early stage classic Hodgkin lymphoma (stages IA, IB, IIA, or IIB). Participants must have a specific type of tumor that's visible and measurable on scans. They should be relatively healthy overall (ECOG ≤ 2) and not have had much prior treatment for their lymphoma—up to two cycles of ABVD chemotherapy are okay. People with severe neuropathy, other recent cancers, certain heart conditions, known allergies to the drugs used in this study or their components, active infections like hepatitis B/C or HIV (with some exceptions), autoimmune diseases, or those who are pregnant/breastfeeding cannot join.Check my eligibility
What is being tested?
The trial is testing brentuximab vedotin combined with nivolumab against classic Hodgkin lymphoma. Brentuximab vedotin targets cancer cells by attaching to them and delivering a toxic agent called vedotin. Nivolumab works by helping the immune system attack cancer cells more effectively. The study aims to see how well these treatments work together in early-stage patients.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site where the drug enters the body through a vein; nerve damage causing numbness or tingling; fatigue; immune-related effects where the body attacks its own tissues; increased risk of infections due to weakened immunity; and potential harm if you're pregnant.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a cancer lesion larger than 1.5 cm that shows up on scans and is active on PET.
Select...
My Hodgkin's lymphoma is in an early stage (IA, IB, IIA, IIB) according to the Cotswold/Ann Arbor system.
Select...
I can take care of myself and am up and about more than half of the day.
Select...
My diagnosis is classical Hodgkin lymphoma, not the nodular lymphocyte-predominant type.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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
18-month Progression-free survival (PFS) for each arm of therapy
Secondary outcome measures
3-year PFS for each arm of treatment
Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
Overall survival for each arm of treatment
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group II (AVD, brentuximab vedotin, nivolumab)Experimental Treatment6 Interventions
Patients receive doxorubicin IV, vinblastine IV, dacarbazine, IV and brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients that are PET/CT negative receive nivolumab IV over 60 minutes on day 1. Treatment with nivolumab repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Group I Arm B (ABVD, nivolumab)Experimental Treatment6 Interventions
Patients receive doxorubicin IV, bleomycin IV, vinblastine IV, dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60 minutes on day 1. Treatment with nivolumab repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Group III: Group I Arm A (brentuximab vedotin, nivolumab)Experimental Treatment3 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 3 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vinblastine
1998
Completed Phase 3
~5260
Nivolumab
2014
Completed Phase 3
~4750
Bleomycin
2001
Completed Phase 3
~4960
Brentuximab Vedotin
2015
Completed Phase 4
~1100
Doxorubicin
2012
Completed Phase 3
~7940
Dacarbazine
2005
Completed Phase 3
~5110

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,305 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,998 Total Patients Enrolled
Alex F HerreraPrincipal InvestigatorCity of Hope Medical Center
11 Previous Clinical Trials
1,406 Total Patients Enrolled

Frequently Asked Questions

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

How many participants can enroll in this study at its maximum capacity?

"This clinical trial necessitates the enrolment of 264 individuals that qualify for inclusion. Participants have a choice to join at either University of Pennsylvania/Abramson Cancer Center in Philadelphia, Pennsylvania or Northwestern University in Chicago, Illinois."

Answered by AI

What ailments is Nivolumab commonly prescribed to treat?

"Nivolumab is often prescribed for complete resection of tissue. It has also been found to be efficacious in patients with acute myeloid leukemia, primary cutaneous anaplastic large cell lymphoma, and acute lymphoblastic leukaemia (ALL)."

Answered by AI

Has the FDA given its seal of approval to Nivolumab yet?

"The risk associated with Nivolumab has been scored a 2, as this is still in the Phase 2 stage of clinical trials and there are no data points yet that confirm its efficacy."

Answered by AI

Is this clinical experiment unprecedented in its field?

"Since its initial 1997 trial, sponsored by Alfacell and involving 300 patients, Nivolumab has seen 1267 studies conducted across 75 countries and 3053 cities. Currently there are 1192 live trials for the medication."

Answered by AI

How many healthcare centers are offering this clinical experiment?

"As of now, this trial is enrolling individuals from 17 sites located across the country. These include Philadelphia, Chicago and Atlanta as well as 14 other cities. To reduce travel demands, we recommend you to pick a clinic nearest to your residence if you decide to join the study."

Answered by AI

Has there been any research conducted concerning Nivolumab previously?

"Nivolumab has been studied for over two decades, with 1267 studies already completed. At this moment 1192 clinical trials are ongoing, a substantial number of which are based in Philadelphia. The first research initiatives were launched at Spectrum Health Hospital - Butterworth Campus back in 1997."

Answered by AI

Are researchers still recruiting participants for this experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this medical trial is actively recruiting patients since it was first posted in 2018 and last updated in 2021. For its completion, 264 individuals will need to be recruited from 17 different locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Brentuximab Vedotin and Nivolumab in Treating Patients With Early Stage Classic Hodgkin Lymphoma
2018. "Brentuximab Vedotin and Nivolumab in Treating Patients With Early Stage Classic Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03712202.
~24 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top