OncRef

Clinical Trial: NCT03907488

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-10-01

Study Overview

Brief 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.

Official Title

A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

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

Intervention / Treatment

  • Procedure: Biospecimen Collection
  • Drug: Brentuximab Vedotin
  • Procedure: Computed Tomography
  • Drug: Dacarbazine
  • Drug: Doxorubicin Hydrochloride
  • Biological: Filgrastim
  • Procedure: Magnetic Resonance Imaging
  • Biological: Nivolumab
  • Biological: Pegfilgrastim
  • Procedure: Positron Emission Tomography
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Radiation: Radiation Therapy
  • Drug: Vinblastine Sulfate

Other Study ID Numbers

  • NCI-2019-01960
  • NCI-2019-01960
  • S1826
  • S1826
  • U10CA180888

Start Date (Actual)

2019-08-29

Primary Completion Date (Actual)

2024-03-31

Study Completion Date (Estimated)

2027-03-28

Enrollment (Actual)

994

Study Type

Interventional

Phase

Phase 3