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Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma

StatusActive, Not Recruiting
PhasePhase 3
Started2021-10-05
View on ClinicalTrials.gov ↗
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs 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. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.

Amendment record

Amended 481 times since 2021-02-17; most recent filed 2026-08-21. The 50 most recent of 482 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 2026-08-29.

2026-08-21
Amendment Study Status v481
2026-07-07
Amendment Study Status, Arms and Interventions v480
2026-06-16
Amendment Study Status, Contacts/Locations v479
2026-06-02
Amendment Study Status, Arms and Interventions v478
2026-05-23
Amendment Study Status, Contacts/Locations v477
2026-05-12
Amendment Study Status, Arms and Interventions v476
2026-05-01
Amendment Study Status, Contacts/Locations v475
2026-04-09
Amendment Study Status v474
2026-04-08
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2026-04-07
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2026-04-04
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2026-04-03
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2026-04-02
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2026-04-01
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2026-03-31
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2026-03-28
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2026-03-27
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2026-03-26
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2026-03-25
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2026-03-24
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2026-03-21
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2026-03-20
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2026-03-19
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2026-03-18
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2026-03-14
Amendment Study Status, Document Section v457
2026-03-13
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2026-03-12
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2026-03-11
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2026-03-10
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2026-03-07
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2025-11-14
Amendment Study Status, Contacts/Locations v451
2025-09-20
Amendment Study Status, Contacts/Locations v450
2025-09-19
Amendment Study Status v449
2025-09-06
Amendment Study Status v448
2025-09-02
Amendment Study Status, Arms and Interventions v447
2025-08-29
Amendment Study Status, Study Description, Eligibility v446
2025-08-15
Amendment Study Status v445
2025-07-25
Amendment Study Status, Contacts/Locations v444
2025-07-08
Amendment Study Status, Contacts/Locations v443
2025-06-03
Amendment Study Status v442
2025-05-29
Amendment Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v441
2025-05-27
Amendment Study Status v440
2025-05-22
Amendment Study Status, Contacts/Locations v439
2025-05-16
Amendment Study Status, Contacts/Locations v438
2025-05-10
Amendment Study Status, Contacts/Locations v437
2025-05-09
Amendment Study Status, Contacts/Locations v436
2025-05-06
Amendment Study Status, Contacts/Locations v435
2025-05-03
Amendment Study Status, Contacts/Locations v434
2025-05-02
Amendment Study Status, Contacts/Locations v433
2025-05-01
Amendment Study Status, Contacts/Locations v432
Trial Details
NCT Number NCT04759586
Lead Sponsor National Cancer Institute (NCI)
Conditions Primary Mediastinal Large B-Cell Lymphoma
Enrollment 244 participants
Start Date 2021-10-05
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-24