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.
Histologically confirmed classical Hodgkin lymphoma
Patients must be 12 years of age or older
Patients enrolled to cohort A must have received only ONE prior brentuximab-containing regimen with NO prior checkpoint inhibitors. Patients enrolled to cohort A must have received brentuximab as part of their first-line treatment regimen.
Patients enrolled to cohort B must have received only ONE prior immune checkpoint inhibitor- (i.e. nivolumab or pembrolizumab) containing regimen and NO prior brentuximab. Patients in cohort B may have received an immune checkpoint inhibitor during either their first- or second-line treatment regimen.
Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for >= 2 years or which will not limit survival to < 2 years
Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events to =< grade 1
Active autoimmune disease or history of autoimmune disease such as hepatitis, hypophysitis, nephritis, interstitial lung disease, and colitis
Active central nervous system (CNS) involvement with lymphoma
Single group
Brentuximab Vedotin
DrugGiven IV
Hematopoietic Cell Transplantation
Procedure/SurgeryUndergo HSCT
Nivolumab
Biological/VaccineGiven IV
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Overall response rate (ORR)
Will be calculated and a 95% confidence interval will be estimated using the Clopper-Pearson method. Assessed per Lugano 2014 Criteria at any time point while on study therapy. Will be analyzed independently for each cohort (A and B).
Complete response rate (CRR)
Will be calculated and a 95% confidence interval will be estimated using the Clopper-Pearson method. Will be determined per Lugano 2014 criteria at any disease assessment time point while the patient is receiving study therapy.
Progression-free survival (PFS)
Will be described using the Kaplan-Meier methodology. 95% confidence intervals for 1-year and 2-year PFS will be calculated, with standard errors estimated using the Greenwood formula. Patients alive without disease progression will be censored at last follow-up date.
Overall survival (OS)
Will be described using the Kaplan-Meier methodology. 95% confidence intervals for 1-year and 2-year OS will be calculated, with standard errors estimated using the Greenwood formula. Patients who have not died will be censored at last follow-up date.
Incidence of adverse events
According to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).
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Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
