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

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo peripheral blood collection
• Brentuximab Vedotin — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo PET/CT or CT scan
• Dacarbazine — DRUG
  Given IV
• Doxorubicin Hydrochloride — DRUG
  Given IV
• Filgrastim — BIOLOGICAL
  Given SC or IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Nivolumab — BIOLOGICAL
  Given IV
• Pegfilgrastim — BIOLOGICAL
  Given SC
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT scan
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies
• Radiation Therapy — RADIATION
  Receive radiation therapy
• Vinblastine Sulfate — DRUG
  Given IV

Study Details

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.

Key Dates

Start date

Aug 29, 2019

Status verified

Mar 2026

Primary completion

Mar 31, 2024

Completion

Mar 28, 2027

Study Design

Enrollment

994 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (chemotherapy, nivolumab, radiation)
  Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
• Experimental: Arm II (chemotherapy, brentuximab vedotin, radiation)
  Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From date of registration to date of first observation of progressive disease, or death due to any cause, assessed at 2 years ]

Locations (713)

Related coverage on Hipa.ai

• Nivolumab Regimen Shows Improved PFS vs Brentuximab Vedotin in Stage III-IV…
  Nivolumab · Jun 12, 2025 · ClinicalTrials.gov
• Nivolumab Phase 3 Trial for Hodgkin Lymphoma Achieves Significant PFS (p=0.005)
  Nivolumab · Mar 31, 2024 · ClinicalTrials.gov

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