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Monoclonal Antibodies

Brentuximab Vedotin + Nivolumab for Hodgkin's Lymphoma

Phase 3
Recruiting
Led By Tara O Henderson
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to 12 years
Awards & highlights

Summary

This trial compares adding immunotherapy to standard chemo/radiation for Hodgkin lymphoma to improve survival.

Who is the study for?
This trial is for patients aged 5-60 with newly diagnosed, untreated classical Hodgkin lymphoma stages I or II. They must have proper kidney and liver function, no severe lung conditions, not be on high-dose steroids or immunosuppressants, and not have other active serious illnesses. Pregnant women and those who haven't agreed to use effective contraception are excluded.Check my eligibility
What is being tested?
The study compares standard chemotherapy (with drugs like doxorubicin and prednisone) plus radiation against the same treatment combined with immunotherapy drugs Brentuximab Vedotin and Nivolumab. The goal is to see if adding these two drugs improves survival rates.See study design
What are the potential side effects?
Possible side effects include immune system reactions, infusion-related responses, fatigue, nausea, hair loss from chemo; Brentuximab may cause nerve damage; Nivolumab can lead to inflammation in organs like lungs or intestines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to 12 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 12 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
PFS in slow-early responder (SER) patients
Progression-free survival (PFS) in rapid early responder (RER) patients
Secondary outcome measures
Contribution of SDOH to OS by race/ethnicity
Contribution of SDOH to PFS by race/ethnicity
Contribution of social determinants of health (SDOH) to initial response to therapy by race/ethnicity
+15 more
Other outcome measures
Agreement between AI derived FDG-PET measurement extraction and physician-based manual quantitative PET measurement
Association between FDG PET parameters obtained by automated measurements and PFS
Association between self-reported race/ethnicity and dimensional SDOH
+5 more

Trial Design

8Treatment groups
Experimental Treatment
Active Control
Group I: Arm H (ABVD, brentuximab vedotin, nivolumab, ISRT)Experimental Treatment13 Interventions
Patients receive treatment and imaging, and may undergo blood sample collection as in arm D.
Group II: Arm G (ABVD, eBEACOPP, ISRT)Experimental Treatment18 Interventions
Patients receive treatment and imaging, and may undergo blood sample collection as in arm C.
Group III: Arm F (ABVD, brentuximab vedotin, nivolumab)Experimental Treatment12 Interventions
Patients receive treatment as in arm B. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
Group IV: Arm E (ABVD, AVD)Experimental Treatment10 Interventions
Patients receive AVD regimen (doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV) on days 1 and 15 of each treatment cycle. Each cycle lasts 28 days. Treatment continues for 4 cycles. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
Group V: Arm D (ABVD, brentuximab vedotin, nivolumab, ISRT)Experimental Treatment13 Interventions
Patients receive brentuximab vedotin IV and nivolumab IV as in arm B followed by ISRT. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
Group VI: Arm C (ABVD, eBEACOPP, ISRT)Experimental Treatment18 Interventions
Patients receive eBEACOPP regimen (doxorubicin hydrochloride IV on day 1, cyclophosphamide IV on day 1, etoposide or etoposide phosphate IV on days 1-3, prednisone or prednisolone orally [PO] daily for the first 14 days of each treatment cycle, procarbazine hydrochloride PO on days 1-7, bleomycin sulfate IV on day 8, and vincristine sulfate IV) on day 8 of each treatment cycle. Treatment continues for 2 cycles. Each cycle lasts 21 days. Subsequently, patients undergo ISRT. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
Group VII: Arm B (ABVD, brentuximab vedotin, nivolumab)Experimental Treatment12 Interventions
Patients receive brentuximab vedotin IV and nivolumab IV once during each treatment cycle. Each cycle lasts 21 days. Treatment continues for 4 cycles. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
Group VIII: Arm A (ABVD)Active Control10 Interventions
Patients receive ABVD IV for an additional 2 cycles on study. Each cycle lasts 28 days and ABVD is administered on days 1 and 15 of each cycle. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or magnetic resonance imaging (MRI) throughout the trial. Patients may also undergo blood sample collection on trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Cyclophosphamide
1995
Completed Phase 3
~3770
Dacarbazine
2005
Completed Phase 3
~5110
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17860
Etoposide
2010
Completed Phase 3
~2440
Etoposide Phosphate
2011
Completed Phase 2
~160
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Nivolumab
2014
Completed Phase 3
~4740
Positron Emission Tomography
2008
Completed Phase 2
~2210
Prednisolone
2005
Completed Phase 4
~2720
Prednisone
2014
Completed Phase 4
~2370
Procarbazine Hydrochloride
2010
Completed Phase 2
~170
Vinblastine Sulfate
2007
Completed Phase 4
~300
Vincristine Sulfate
2005
Completed Phase 3
~10160
Biospecimen Collection
2004
Completed Phase 2
~1720
Bleomycin Sulfate
2010
Completed Phase 3
~1960
Brentuximab Vedotin
2015
Completed Phase 4
~1070

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,957,526 Total Patients Enrolled
Tara O HendersonPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials
376 Total Patients Enrolled

Media Library

Brentuximab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05675410 — Phase 3
Hodgkin's Lymphoma Research Study Groups: Arm G (ABVD, eBEACOPP, ISRT), Arm A (ABVD), Arm B (ABVD, brentuximab vedotin, nivolumab), Arm C (ABVD, eBEACOPP, ISRT), Arm D (ABVD, brentuximab vedotin, nivolumab, ISRT), Arm E (ABVD, AVD), Arm F (ABVD, brentuximab vedotin, nivolumab), Arm H (ABVD, brentuximab vedotin, nivolumab, ISRT)
Hodgkin's Lymphoma Clinical Trial 2023: Brentuximab Vedotin Highlights & Side Effects. Trial Name: NCT05675410 — Phase 3
Brentuximab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05675410 — Phase 3
~1250 spots leftby Apr 2031