A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Relapsed or Refractory From First Line Treatment

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02927769
Phase
PHASE2
Status
Completed

Conditions

  • Hodgkin Disease

Eligibility Criteria

Sex
ALL
Age
5 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — BIOLOGICAL
    Specified Dose on Specified Days
  • brentuximab vedotin — BIOLOGICAL
    Specified Dose on Specified Days
  • bendamustine — BIOLOGICAL
    Specified Dose on Specified Days

Study Details

The purpose of this study is to determine whether nivolumab plus brentuximab vedotin (followed by brentuximab vedotin plus bendamustine in patient with suboptimal response) is safe and effective in treating patients with Hodgkin's lymphoma (cHL). Eligible patients are children, adolescents, and young adults relapsed or refractory to first line.

Key Dates

Start date
Mar 28, 2017
Status verified
Jan 2025
Primary completion
May 28, 2024
Completion
May 28, 2024

Study Design

Enrollment
72 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab + brentuximab vedotin
  • Experimental: brentuximab vedotin + bendamustine

Primary Outcome Measure

Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Blinded Independent Centralized Review (BICR) - Cohort 1 [ Time Frame: From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks). ]

Locations (43)

FacilityCityStateZIPSite coordinators
Children's Hospital of AlabamaBirminghamAlabama35233-
Phoenix Children'S HospitalPhoenixArizona85016-
Loma Linda University Cancer CenterLoma LindaCalifornia92350-
Valley Children's HospitalMaderaCalifornia93636-
Children'S Hospital & Research Center At OaklandOaklandCalifornia94609-
Children'S Hospital Of Orange CountyOrangeCalifornia92868-
Lucile Packard Children'S Research Hospital/Stanford UnivPalo AltoCalifornia94304-
Local Institution - 0091San DiegoCalifornia92109-
Childrens Hospital of ColoradoAuroraColorado80045-
Smilow Cancer Hospital At Yale New Haven HospitalNew HavenConnecticut06520-
Nemours / A. I. duPont Hospital for ChildrenWilmingtonDelaware19803-
Children'S National Medical CenterWashington D.C.District of Columbia20010-
Local Institution - 0062JacksonvilleFlorida32207-
Local Institution - 0069St. PetersburgFlorida33701-
Children's Healthcare Of AtlantaAtlantaGeorgia30322-
University Of IowaIowa CityIowa52242-
Local Institution - 0070BaltimoreMaryland21287-
Dana Farber Cancer Institute.BostonMassachusetts02215-
Local Institution - 0097DetroitMichigan48201-
Local Institution - 0049JacksonMississippi39216-
Local Institution - 0085Kansas CityMissouri64108-
Washington University School Of MedicineSt LouisMissouri63110-
Nevada Cancer Research FoundationLas VegasNevada89135-
Local Institution - 0067HackensackNew Jersey07601-
Local Institution - 0047New BrunswickNew Jersey08903-
Local Institution - 0068BuffaloNew York14263-
Local InstitutionChapel HillNorth Carolina27599-
Carolinas Medical CenterCharlotteNorth Carolina28203-
Cincinnati Children'S Hospital Medical CenterCincinnatiOhio45229-3039-
Local Institution - 0089ColumbusOhio43205-
University Of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Local Institution - 0090HersheyPennsylvania17033-0850-
Childrens Hospital Of PhiladelphiaPhiladelphiaPennsylvania19104-
Childrens Hospital Of Pittsburgh Of UpmcPittsburghPennsylvania15224-
Vanderbilt UniversityNashvilleTennessee37232-6310-
Local Institution - 0042AustinTexas78723-
Local Institution - 0071DallasTexas75235-
Baylor College Of MedicineHoustonTexas77030-
Primary Children's HospitalSalt Lake CityUtah84113-
Children'S Hosp-Kings DaughterNorfolkVirginia23507-1910-
Virginia Commonwealth UniversityRichmondVirginia23219-
Local Institution - 0048SeattleWashington98105-
Local Institution - 0065MilwaukeeWisconsin53226-

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Children's Hospital of Alabama· Birmingham, ALPhoenix Children'S Hospital· Phoenix, AZLoma Linda University Cancer Center· Loma Linda, CAValley Children's Hospital· Madera, CAChildren'S Hospital & Research Center At Oakland· Oakland, CAChildren'S Hospital Of Orange County· Orange, CA

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