BENITIONSClinical Trial Intelligence

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

Phase 3 Active, not recruiting NCT03907488

ConditionAnn 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
PhasePhase 3
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment994 participants
InterventionsBiospecimen Collection, Brentuximab Vedotin, Computed Tomography, Dacarbazine, Doxorubicin Hydrochloride
Start dateAug 29, 2019
Completion dateMar 31, 2024
Results postedJun 12, 2025

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.

Progression Free Survival (PFS)

From date of registration to date of first observation of progressive disease, or death due to any cause, assessed at 2 years · Participants

Arm I (Chemotherapy, Nivolumab, Radiation)41 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)81 Participants
p-value<0.005

Open in BENITIONS View on ClinicalTrials.gov

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