Trials / Active Not Recruiting

Active Not RecruitingNCT03712202

Brentuximab Vedotin and Nivolumab in Treating Patients With Early Stage Classic Hodgkin Lymphoma

A Phase 2 Front-Line PET/CT-2 Response-Adapted Brentuximab Vedotin and Nivolumab Incorporated and Radiation-Free Management of Early Stage Classical Hodgkin Lymphoma (cHL)

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 155 (actual)

Sponsor: City of Hope Medical Center · Academic / Other
Sex: All
Age: 16 Years
Healthy volunteers: Not accepted

Summary

This phase II trial studies how well brentuximab vedotin and nivolumab work in treating patients with stage I-II classic Hodgkin lymphoma. 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.

Detailed description

PRIMARY OBJECTIVE: I. Determine the 18-month progression free survival (PFS) for each arm of therapy stratified by positron emission tomography (PET)/computed tomography (CT)-2 response. SECONDARY OBJECTIVES: I. Assess safety, tolerability, and quality of life (QOL) for each arm of therapy. II. Measure PET/CT-2 negativity rate after 2 lead-in cycles of standard of care doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD). III. Evaluate the 3-year PFS and overall survival (OS) for each arm of treatment. EXPLORATORY OBJECTIVES: I. Evaluate if a baseline antitumor immune response, as assessed by a Nanostring gene panel, correlates with PFS. II. Evaluate if minimal residual disease (MRD) status, as monitored by cancer personalized profiling by deep sequencing (CAPP-Seq) of circulating tumor (ct) deoxyribonucleic acid (DNA), can be correlated with PFS. OUTLINE: Patients are assigned to 1 of 2 groups based on their PET/CT-2 scans. GROUP I (PET/CT-2 NEGATIVE): Patients without bulky disease are randomized to either Arm A or B and patients with bulky disease are assigned to Arm B. ARM A: Patients receive brentuximab vedotin intravenously (IV) over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive doxorubicin IV, bleomycin IV, vinblastine IV, dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60 minutes on day 1. Treatment with nivolumab repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. GROUP II (PET/CT-2 POSITIVE): Patients receive doxorubicin IV, vinblastine IV, dacarbazine, IV and brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients that are PET/CT negative receive nivolumab IV over 60 minutes on day 1. Treatment with nivolumab repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 3 years.

Conditions

Interventions

Type	Name	Description
DRUG	Bleomycin	Given IV
DRUG	Brentuximab Vedotin	Given IV
DRUG	Dacarbazine	Given IV
DRUG	Doxorubicin	Given IV
BIOLOGICAL	Nivolumab	Given IV
OTHER	Quality-of-Life Assessment	Ancillary studies
DRUG	Vinblastine	Given IV

Timeline

Start date: 2018-11-28
Primary completion: 2024-12-23
Completion: 2024-12-23
First posted: 2018-10-19
Last updated: 2024-11-06

Locations

17 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03712202. Inclusion in this directory is not an endorsement.