NCT02758717

Nivolumab and Brentuximab Vedotin in Treating Older Patients With Untreated Hodgkin Lymphoma

Phase II, Multi-Center Trial of Nivolumab and Brentuximab Vedotin in Patients With Untreated Hodgkin Lymphoma Over the Age of 60 Years or Unable to Receive Standard Adriamycin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) Chemotherapy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Academic and Community Cancer Research United · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well nivolumab and brentuximab vedotin work in treating older patients with untreated Hodgkin lymphoma. 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. Biological therapies, such as brentuximab vedotin, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Nivolumab and brentuximab vedotin may work better in treating older patients with untreated Hodgkin lymphoma.

Detailed description

PRIMARY OBJECTIVE: I. To determine the efficacy based on overall metabolic response rate (partial metabolic response \[PMR\] + complete metabolic remission \[CMR\]) of brentuximab vedotin/nivolumab in previously untreated Hodgkin lymphoma patients 60 years of age or older, or those considered unsuitable for standard chemotherapy because of a low cardiac ejection fraction (\< 50%) or impaired pulmonary or renal function. SECONDARY OBJECTIVES: I. The complete metabolic response (CMR) rate. II. Safety and tolerability of the regimen in this patient population. III. Duration of response (DOR). IV. Progression-free survival (PFS). V. Overall survival (OS). CORRELATIVE RESEARCH OBJECTIVES: I. T-cell/cytokine - peripheral blood specimens will be used to assess T-cell activation and cytokine up regulation as measures of treatment effect. II. Biomarkers - intratumoral cell populations, genetic variability, serum cytokines and T-cell activation will be evaluated to identify potential biomarkers that correlate with response to therapy. OUTLINE: Patients receive brentuximab vedotin intravenously (IV) over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for 7 cycles and 6-8 weeks in cycle 8 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 30 days for 90 days, every 90 days for 2.5 years, and then every 6 months until 5 years from registration.

Conditions

• Ann Arbor Stage IB Hodgkin Lymphoma
• Ann Arbor Stage II Hodgkin Lymphoma
• Ann Arbor Stage IIA Hodgkin Lymphoma
• Ann Arbor Stage IIB Hodgkin Lymphoma
• Ann Arbor Stage III Hodgkin Lymphoma
• Ann Arbor Stage IIIA Hodgkin Lymphoma
• Ann Arbor Stage IIIB Hodgkin Lymphoma
• Ann Arbor Stage IV Hodgkin Lymphoma
• Ann Arbor Stage IVA Hodgkin Lymphoma
• Ann Arbor Stage IVB Hodgkin Lymphoma
• Classic Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Brentuximab Vedotin	Given IV
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2016-05-13
• Primary completion: 2019-08-13
• Completion: 2025-09-13
• First posted: 2016-05-02
• Last updated: 2025-09-09
• Results posted: 2020-09-22

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study