RecruitingPhase 2NCT05039073

Brentuximab Vedotin and Nivolumab for the Treatment of Relapsed/Refractory Classic Hodgkin Lymphoma Previously Treated With Brentuximab Vedotin or Checkpoint Inhibitors

A Phase 2 Study of Brentuximab Vedotin Plus Nivolumab in Patients With Relapsed/Refractory Hodgkin Lymphoma Previously Treated With Brentuximab or Checkpoint Inhibitors


Sponsor

Emory University

Enrollment

46 participants

Start Date

May 2, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of brentuximab vedotin and nivolumab in patients with classical Hodgkin lymphoma whose cancer has relapsed after initial treatment with one of these drugs (but not both). **You may be eligible if...** - You are 12 years of age or older with classical Hodgkin lymphoma - Your cancer came back after one prior treatment that included either brentuximab or nivolumab/pembrolizumab — but not both - You have not had a stem cell transplant - You have measurable cancer on imaging - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have had chemotherapy or radiation within the past 2 weeks - You have an active autoimmune disease - Your lymphoma has spread to the brain - You have active hepatitis B or C - You have had another cancer recently (within 2 years) that could limit survival - You are pregnant or unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBrentuximab Vedotin

Given IV

PROCEDUREHematopoietic Cell Transplantation

Undergo HSCT

BIOLOGICALNivolumab

Given IV

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies


Locations(2)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

View Full Details on ClinicalTrials.gov

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NCT05039073


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