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
- Conditions
- Hodgkin Disease
- Interventions
- Biological: NivolumabBiological: bendamustineBiological: brentuximab vedotin
- Registration Number
- NCT02927769
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- Classic Hodgkin Lymphoma (cHL), relapsed or refractory
- Minimal limitation on activities of daily living as measured by Karnofsky ≥ 50 for participants > 16 years of age or Lansky ≥ 50 for participants ≤ 16 years of age.
- One prior anti-cancer therapy that did not work
- Active, known, or suspected autoimmune disease or infection
- Active cerebral/meningeal disease related to the underlying malignancy
- More than one line of anti-cancer therapy or no treatment at all
- Received a stem cell transplant for Hodgkin Lymphoma and/or a solid organ transplant
- Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
Other protocol defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nivolumab + brentuximab vedotin Nivolumab - brentuximab vedotin + bendamustine bendamustine - Nivolumab + brentuximab vedotin brentuximab vedotin - brentuximab vedotin + bendamustine brentuximab vedotin -
- Primary Outcome Measures
Name Time Method Complete Metabolic Response (CMR) rate at any time prior to radiation therapy Up to 5 years Low Risk Group. The CMR rate is defined as the proportion of all response-evaluable participants who, assessed by the BICR, achieve best response of CMR using Lugano 2014 criteria.
Event Free Survival (EFS) Up to 5 years Low Risk Group. Based on blinded independent central review (BICR)
Complete Metabolic Response (CMR) rate prior to HDCT/ASCT Up to 5 years Standard Risk Group. This is the rate prior to high-dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) based on the blinded independent central review (BICR) using Lugano 2014 criteria.
- Secondary Outcome Measures
Name Time Method Incidence of clinically significant vital sign measurements of nivolumab (BMS-936558) and brentuximab when given in combination. Up to 5 years Temperature, Blood Pressure and Heart Rate
Progression Free Survival Rate (PFSR) Up to 5 years Both Risk Groups. Based on investigator assessments
Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment Up to 12 weeks Both Risk Groups. Based on investigator assessments
Incidence of serious and non-serious adverse events of nivolumab (BMS-936558) and brentuximab when given in combination. Up to 5 years measured by number of patients
Duration of Response (DOR) Up to 5 years Both Risk Groups. Based on investigator assessments
Event Free Survival (EFS) Up to 5 years Low Risk Group. Based on investigator assessments
Incidence of clinically significant abnormalities in general laboratory tests of nivolumab (BMS-936558) and brentuximab when given in combination. Up to 5 years Hematology, Chemistry and Urinalysis
Complete Metabolic Response (CMR) rate prior to HDCT/ASCT Up to 5 years Standard Risk Group. This is the rate prior to high-dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) based on investigator assessments using Lugano 2014 criteria.
Complete Metabolic Response (CMR) rate at any time prior to radiation therapy Up to 5 years Low Risk Group. This is the rate prior to radiation therapy based on investigator assessments using Lugano 2014 criteria.
Trial Locations
- Locations (73)
Loma Linda University Cancer Center
🇺🇸Loma Linda, California, United States
Children'S Hospital & Research Center At Oakland
🇺🇸Oakland, California, United States
Children'S Hospital Of Orange County
🇺🇸Orange, California, United States
Children'S National Medical Center
🇺🇸Washington, District of Columbia, United States
Local Institution - 0062
🇺🇸Jacksonville, Florida, United States
Local Institution - 0069
🇺🇸Saint Petersburg, Florida, United States
Children's Healthcare Of Atlanta
🇺🇸Atlanta, Georgia, United States
University Of Iowa
🇺🇸Iowa City, Iowa, United States
Local Institution - 0049
🇺🇸Jackson, Mississippi, United States
Washington University School Of Medicine
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0068
🇺🇸Buffalo, New York, United States
Local Institution
🇬🇧Glasgow, United Kingdom
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Local Institution - 0090
🇺🇸Hershey, Pennsylvania, United States
Childrens Hospital Of Pittsburgh Of Upmc
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0071
🇺🇸Dallas, Texas, United States
Children'S Hosp-Kings Daughter
🇺🇸Norfolk, Virginia, United States
The Montreal Children's Hospital of the MUHC
🇨🇦Montreal, Quebec, Canada
Local Institution - 0092
🇨🇦Toronto, Ontario, Canada
Klinika detske hematologie a onkologie
🇨🇿Praha 5, Czechia
Local Institution - 0034
🇫🇷Vandoeuvre lès Nancy, Meurthe-et-Moselle, France
Local Institution - 0030
🇫🇷Lille cedex, France
Local Institution - 0032
🇫🇷Marseille, France
Local Institution - 0029
🇫🇷Lyon Cedex 08, France
Local Institution - 0028
🇫🇷Nantes, France
Local Institution - 0031
🇫🇷Paris, France
Local Institution - 0033
🇫🇷Toulouse cedex 9, France
Local Institution - 0027
🇫🇷Villejuif, France
Local Institution - 0056
🇩🇪Berlin, Germany
Local Institution - 0055
🇩🇪Giessen, Germany
Local Institution - 0057
🇩🇪Hannover, Germany
Local Institution - 0102
🇩🇪Muenchen, Germany
Local Institution - 0017
🇮🇪Dublin, Ireland
Local Institution - 0021
🇮🇹Genova, Italy
Local Institution - 0023
🇮🇹Napoli, Italy
Local Institution - 0001
🇳🇱Rotterdam, Netherlands
Local Institution - 0022
🇮🇹Roma, Italy
Valley Children's Hospital
🇺🇸Madera, California, United States
Local Institution - 0006
🇳🇱Utrecht, Netherlands
Local Institution - 0082
🇪🇸Barcelona, Spain
Local Institution - 0084
🇪🇸Madrid, Spain
Local Institution - 0002
🇬🇧London, United Kingdom
Local Institution - 0012
🇬🇧Manchester, United Kingdom
Local Institution - 0089
🇺🇸Columbus, Ohio, United States
Local Institution - 0070
🇺🇸Baltimore, Maryland, United States
Local Institution - 0091
🇺🇸San Diego, California, United States
Dana Farber Cancer Institute.
🇺🇸Boston, Massachusetts, United States
Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Cincinnati Children'S Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States
Local Institution - 0048
🇺🇸Seattle, Washington, United States
Local Institution - 0035
🇬🇧Leeds, North Yorkshire, United Kingdom
Childrens Hospital Of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 0047
🇺🇸New Brunswick, New Jersey, United States
Local Institution - 0067
🇺🇸Hackensack, New Jersey, United States
Phoenix Children'S Hospital
🇺🇸Phoenix, Arizona, United States
Local Institution - 0097
🇺🇸Detroit, Michigan, United States
University Of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Children's Hospital of Alabama
🇺🇸Birmingham, Alabama, United States
Local Institution - 0065
🇺🇸Milwaukee, Wisconsin, United States
Childrens Hospital of Colorado
🇺🇸Aurora, Colorado, United States
Lucile Packard Children'S Research Hospital/Stanford Univ
🇺🇸Palo Alto, California, United States
Nemours / A. I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Local Institution - 0026
🇫🇷Paris, France
Local Institution - 0024
🇮🇹Aviano (PN), Italy
Local Institution - 0020
🇮🇹Bologna, Italy
Local Institution - 0019
🇮🇹Monza (mb), Italy
Baylor College Of Medicine
🇺🇸Houston, Texas, United States
Smilow Cancer Hospital At Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Local Institution - 0085
🇺🇸Kansas City, Missouri, United States
Local Institution - 0042
🇺🇸Austin, Texas, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States