Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma

Summary

This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic 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. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.

Conditions

• Ann Arbor Stage III Hodgkin Lymphoma
• Ann Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma
• Ann Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma
• Ann Arbor Stage III Nodular Sclerosis Classic Hodgkin Lymphoma
• Ann Arbor Stage IV Hodgkin Lymphoma
• Ann Arbor Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma
• Ann Arbor Stage IV Mixed Cellularity Classic Hodgkin Lymphoma
• Ann Arbor Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma
• Classic Hodgkin Lymphoma
• Lymphocyte-Rich Classic Hodgkin Lymphoma

Interventions

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Radiation Therapy

Receive radiation therapy

DRUG

Vinblastine Sulfate

Given IV

PROCEDURE

Biospecimen Collection

Undergo peripheral blood collection

DRUG

Brentuximab Vedotin

Given IV

PROCEDURE

Computed Tomography

Undergo PET/CT or CT scan

DRUG

Dacarbazine

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

BIOLOGICAL

Filgrastim

Given SC or IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Nivolumab

Given IV

BIOLOGICAL

Pegfilgrastim

Given SC

PROCEDURE

Positron Emission Tomography

Undergo PET/CT scan

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Alex F Herrera · SWOG Cancer Research Network

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-29

Primary Completion

2024-03-31

Completion

2027-03-28

FDA Drug

Yes

Countries

• United States
• Canada
• Puerto Rico

Study Locations