Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05675410 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 501 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Minor Site details revised at 3 of 417 sites
  2. Minor Site details revised at 2 of 417 sites
  3. Minor Site details revised at 1 of 417 sites
  4. Minor Study sites: 416 to 417
  5. Minor Study sites: 415 to 416
Show 4 earlier versionsHide 4 earlier versions
  1. Minor Site contacts updated at 1 of 415 sites
  2. Minor Study sites revised (415)
  3. Minor Site contacts updated at 1 of 415 sites
  4. Minor Study sites: 414 to 415
  1. Minor Trial sites expanded: 409 → 414 locationsv492
  2. Minor Site details revised at 1 of 409 sitesv491
  3. Minor Site details revised at 1 of 409 sitesv490
  4. Minor Site details revised at 4 of 409 sitesv489
  5. Minor Site details revised at 1 of 409 sitesv488
  6. Minor Site details revised at 1 of 409 sitesv487
  7. Minor Site details revised at 1 of 409 sitesv486
  8. Minor Site details revised at 4 of 409 sitesv485
  9. Minor Study sites: 408 to 409v484
  10. Minor Site details revised at 1 of 408 sitesv483
  11. Minor Site details revised at 3 of 408 sitesv482
  12. Minor Site details revised at 4 of 408 sitesv481
  13. Minor Site details revised at 2 of 408 sitesv480
  14. Minor Site details revised at 5 of 408 sitesv479
  15. Minor Site details revised at 2 of 408 sitesv478
  16. Minor Site details revised at 1 of 408 sitesv477
  17. Minor Site details revised at 3 of 408 sitesv476
  18. Minor Site details revised at 1 of 408 sitesv475
  19. Minor Site details revised at 1 of 408 sitesv474
  20. Minor Study sites: 407 to 408v473
  21. Minor Site details revised at 2 of 407 sitesv472
  22. Minor Site details revised at 1 of 407 sitesv471
  23. Minor Site details revised at 2 of 407 sitesv470
  24. Minor Site details revised at 2 of 407 sitesv469
  25. Minor Site details revised at 2 of 407 sitesv468
  26. Minor Site details revised at 5 of 407 sitesv467
  27. Minor Study sites revised (407)v466 See this version in full on ClinicalTrials.gov ↗
  28. Minor Site details revised at 2 of 407 sitesv465
  29. Minor Site contacts updated at 1 of 407 sitesv464
  30. Minor Site details revised at 1 of 407 sitesv463
  31. Minor Site details revised at 3 of 407 sitesv462
  32. Minor Site details revised at 4 of 407 sitesv461
  33. Minor Site details revised at 1 of 407 sitesv460
  34. Minor Site contacts updated at 2 of 407 sitesv459
  35. Minor Site contacts updated at 1 of 407 sitesv458
  36. Minor Site details revised at 1 of 407 sitesv457
  37. Minor Site details revised at 2 of 407 sitesv456
  38. Minor Study sites: 406 to 407v455
  39. Minor Study sites: 405 to 406v454
  40. Minor Site details revised at 1 of 405 sitesv453
  41. Minor Site details revised at 3 of 405 sitesv452
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). 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. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride 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. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.
Trial Details
NCT Number NCT05675410
Lead Sponsor National Cancer Institute (NCI)
Conditions Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8
Enrollment 1,875 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov