Recurrent Classic Hodgkin Lymphoma Clinical Trial
Official title:
A Phase 2 Study of Brentuximab Vedotin Plus Nivolumab Without Stem Cell Consolidation in Patients With Relapsed Classical Hodgkin Lymphoma
This phase II trial investigates how well brentuximab vedotin and nivolumab work in treating patients with classical Hodgkin lymphoma that has come back (relapsed). 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. Nivolumab is an antibody that enhances the immune system to better fight Hodgkin lymphoma cells. Giving brentuximab vedotin and nivolumab may be able to defer stem cell transplant treatment and spare the considerable cost and toxicity on transplantation.
PRIMARY OBJECTIVE: I. Assess the durability of response to brentuximab vedotin (BV) plus nivolumab (nivo) by 24-month progression-free survival (PFS) in participants with 1st relapse of classical Hodgkin lymphoma (RcHL) who achieved early complete metabolic response (CMR) (CMR after 4 cycles). SECONDARY OBJECTIVES: I. Estimate CMR and overall response rate (ORR) after 4 cycles and at the end of BV-nivo therapy. II. Estimate the PFS and overall survival (OS) for the entire cohort and for subgroups of patients defined by their response. III. Estimate the PFS and OS separately for responders who did and did not receive radiotherapy. IV. Evaluate the toxicities of BV-nivo in the study population. EXPLORATORY OBJECTIVES: I. Estimate the second PFS after salvage therapy for patients who progress after study therapy, and for the subset of these patients who proceeded to autologous stem cell transplant (ASCT). II. Explore the association between clinical outcomes and pathological tumor characteristics. III. Explore the association between clinical outcomes and circulating tumor deoxyribonucleic acid (ctDNA) characteristics (mutation profile, kinetics of clearance). OUTLINE: Patients receive brentuximab vedotin intravenously (IV) over 30 minutes and nivolumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and 6, 12, 18, 24, 36, 48, and 60 months. ;
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