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

StatusActive, Not Recruiting
PhasePhase 3
Started2019-08-29
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 543 times since 2019-04-08; most recent filed 2026-08-01. The 50 most recent of 544 record versions are listed below. See every version on ClinicalTrials.gov ↗

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2026-08-01
Amendment Study Status, Contacts/Locations v543
2026-07-07
Amendment Study Status, Arms and Interventions v542
2026-07-01
Amendment Study Status, Contacts/Locations v541
2026-06-30
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2026-06-26
Amendment Study Status, Contacts/Locations v539
2026-06-02
Amendment Study Status, Arms and Interventions v538
2026-05-29
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2026-05-12
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2026-05-01
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2026-04-30
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2026-03-27
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2025-11-14
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2025-10-28
Amendment Study Status, Contacts/Locations v531
2025-09-27
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2025-09-02
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2025-08-02
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2025-07-25
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2025-07-11
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2025-06-13
Amendment Study Status, Arms and Interventions, Contacts/Locations, Document Section v525
2025-05-30
Amendment Study Status, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats, More Information v524
2025-01-01
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2024-12-21
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2024-11-09
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2024-11-07
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2024-10-18
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2024-10-05
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2024-10-01
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2024-09-28
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2024-09-25
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2024-09-24
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2024-08-10
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2024-07-12
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2024-07-10
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2024-07-02
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2024-06-26
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2024-06-06
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2024-05-18
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2024-05-16
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2024-05-15
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2024-04-17
Amendment Study Status, Arms and Interventions, Eligibility, Contacts/Locations v503
2024-01-11
Amendment Study Status, Document Section v502
2024-01-06
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2023-12-12
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2023-12-05
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2023-11-07
Amendment Study Status, Arms and Interventions v498
2023-10-24
Amendment Study Status, Contacts/Locations v497
2023-10-04
Amendment Study Status v496
2023-09-26
Amendment Study Status, Arms and Interventions v495
2023-09-09
Amendment Study Status, Contacts/Locations v494
Trial Details
NCT Number NCT03907488
Lead Sponsor National Cancer Institute (NCI)
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 +2 more
Enrollment 994 participants
Start Date 2019-08-29
Primary Completion 2024-03-31 (estimated)
Study Completion 2027-03-28 (estimated)
Updated on ClinicalTrials.gov 2026-08-04