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Trial Summary


Protocol No.S1826
StatusOPEN TO ACCRUAL
Principal InvestigatorRobertson, Michael
ScopeNational
PhasePhase III
Age GroupAdults and Children
TitleA PHASE III, RANDOMIZED STUDY OF NIVOLUMAB (OPDIVO) PLUS AVD OR BRENTUXIMAB VEDOTIN (ADCETRIS) PLUS AVD IN PATIENTS (AGE >/= 12 YEARS) WITH NEWLY DIAGNOSED ADVANCED STAGE CLASSICAL HODGKIN LYMPHOMA NCT# 03907488
DescriptionThis randomized 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. Drugs used in chemotherapy, 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 EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Patients must not have received any prior chemotherapy, radiation, or antibody-based treatment for classical Hodgkin lymphoma. Steroid pre-treatment is permitted.
  • Patients must not have had prior solid organ transplant.
  • Patients must not have had prior allogeneic stem cell transplantation.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesHodgkin's Lymphoma
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactJill R Weisenbach, RNPhone: +1 317-278-0597
    Pager: +1 317-312-1799
    Email: jweisenb@iu.edu