Brentuximab Vedotin and Nivolumab in Treating Patients With Early Stage Classic Hodgkin Lymphoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
City of Hope Medical Center
Study ID
NCT03712202
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Ann Arbor Stage I Hodgkin Lymphoma
  • Ann Arbor Stage I Lymphocyte-Depleted Classic HL
  • Ann Arbor Stage I Mixed Cellularity Classic Hodgkin Lymphoma
  • Ann Arbor Stage I Nodular Sclerosis Classic Hodgkin Lymphoma
  • Ann Arbor Stage IA Hodgkin Lymphoma
  • Ann Arbor Stage IB Hodgkin Lymphoma
  • Ann Arbor Stage II Hodgkin Lymphoma
  • Ann Arbor Stage II Lymphocyte-Depleted Classic HL
  • Ann Arbor Stage II Mixed Cellularity Classic HL
  • Ann Arbor Stage II Nodular Sclerosis Classic HL
  • Ann Arbor Stage IIA Hodgkin Lymphoma
  • Ann Arbor Stage IIB Hodgkin Lymphoma
  • Classic Hodgkin Lymphoma
  • Lymphocyte-Rich Classic Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bleomycin — DRUG
    Given IV
  • Brentuximab Vedotin — DRUG
    Given IV
  • Dacarbazine — DRUG
    Given IV
  • Doxorubicin — DRUG
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Vinblastine — DRUG
    Given IV

Study Details

This phase II trial studies how well brentuximab vedotin and nivolumab work in treating patients with stage I-II classic Hodgkin lymphoma. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. 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.

Key Dates

Start date
Nov 28, 2018
Status verified
Nov 2024
Primary completion
Dec 23, 2024
Completion
Dec 23, 2024

Study Design

Enrollment
155 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group I Arm A (brentuximab vedotin, nivolumab)
    Patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
  • Experimental: Group I Arm B (ABVD, nivolumab)
    Patients receive doxorubicin IV, bleomycin IV, vinblastine IV, dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60 minutes on day 1. Treatment with nivolumab repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
  • Experimental: Group II (AVD, brentuximab vedotin, nivolumab)
    Patients receive doxorubicin IV, vinblastine IV, dacarbazine, IV and brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients that are PET/CT negative receive nivolumab IV over 60 minutes on day 1. Treatment with nivolumab repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

18-month Progression-free survival (PFS) for each arm of therapy [ Time Frame: Up to 18 months ]

Locations (17)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Cancer CenterBirminghamAlabama35233-
City of Hope Medical CenterDuarteCalifornia91010-
University of California San DiegoSan DiegoCalifornia92103-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalCharlestownMassachusetts02129-
Hackensack University Medical CenterHackensackNew Jersey07601-
NYP/Weill Cornell Medical CenterNew YorkNew York10065-
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterClevelandOhio44195-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Pennsylvania/Abramson Cancer CenterPhiladelphiaPennsylvania19104-
Sarah Cannon Cancer CenterNashvilleTennessee37203-
M D Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham Cancer Center· Birmingham, ALCity of Hope Medical Center· Duarte, CAUniversity of California San Diego· San Diego, CAEmory University Hospital/Winship Cancer Institute· Atlanta, GANorthwestern University· Chicago, ILUniversity of Chicago Comprehensive Cancer Center· Chicago, IL

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