Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UC Davis UC Irvine UCLA UCSD UCSF
Dates
study started
completion around

Description

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

Details

Keywords

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, Lymphoma, Hodgkin Disease, Sclerosis, Immunological Antineoplastic Agents, Nivolumab, Brentuximab Vedotin, Doxorubicin, Liposomal doxorubicin, Dacarbazine, Vinblastine, Antibodies, Immunoglobulins, Monoclonal Antibodies, Lenograstim, Imidazole, Immunoconjugates, Biospecimen Collection, Computed Tomography, Doxorubicin Hydrochloride, Filgrastim, Magnetic Resonance Imaging, Pegfilgrastim, Positron Emission Tomography, Quality-of-Life Assessment, Radiation Therapy, Vinblastine Sulfate, chemotherapy, nivolumab, radiation, chemotherapy, brentuximab vedotin, radiation

Eligibility

Locations

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT03907488
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 994 people participating
Last Updated