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Monoclonal Antibodies

Brentuximab Vedotin + Nivolumab for Hodgkin's Lymphoma

Phase 3

Recruiting

Led By Kara M Kelly

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 from the time of randomization to the earliest time of disease relapse, progression, or death due to any cause, assessed up to 3 years after the randomization of the last patient or when reaching 71 events, whichever comes first

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of randomization to the earliest time of disease relapse, progression, or death due to any cause, assessed up to 3 years after the randomization of the last patient or when reaching 124 events, whichever comes first

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of randomization to the earliest time of disease relapse, progression, or death due to any cause, assessed up to 3 years after the randomization of the last patient or when reaching 124 events, whichever comes first

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of randomization to the earliest time of disease relapse, progression, or death due to any cause, assessed up to 3 years after the randomization of the last patient or when reaching 124 events, whichever comes first for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PFS in slow-early responder (SER) patients

Progression-free survival (PFS) in rapid early responder (RER) patients

Secondary study objectives

Contribution of SDOH to OS by race and ethnicity

Contribution of SDOH to PFS by race and ethnicity

Effect of metabolic tumor burden (MTV) on PFS

+14 more

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

8Treatment groups

Experimental Treatment

Active Control

Group I: Arm H (ABVD, brentuximab vedotin, nivolumab, ISRT)Experimental Treatment13 Interventions

Group II: Arm G (ABVD, eBEACOPP or eBPDac, ISRT)Experimental Treatment18 Interventions

Group III: Arm F (ABVD, brentuximab vedotin, nivolumab)Experimental Treatment12 Interventions

Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then 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 are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive AVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, vinblastine IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. 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 are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then 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 or eBPDac, ISRT)Experimental Treatment18 Interventions

See Detailed Description.

Group VII: Arm B (ABVD, brentuximab vedotin, nivolumab)Experimental Treatment12 Interventions

Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30 minutes once during each treatment cycle. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. 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 are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then 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 in the absence of disease progression or unacceptable toxicity. 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisolone

2005

Completed Phase 4

~3570

Computed Tomography

2017

Completed Phase 2

~2790