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
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT02927769 Active, not recruiting October 7, 2016 September 1, 2022

study description
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.

Condition or Disease: Hodgkin Disease
Intervention/treatment: Biological: Nivolumab
Biological: brentuximab vedotin
Biological: bendamustine
Phase: Phase 2
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 72 participants
Allocation : Non-Randomized
Intervention Model : Parallel Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: March 2017
Estimated Primary Completion Date: January 2024
Estimated Study Completion Date: November 2024

Arms and interventions
Arm Intervention/treatment
Experimental: Nivolumab + brentuximab vedotin
Biological: Nivolumab
Specified Dose on Specified Days

Biological: brentuximab vedotin
Specified Dose on Specified Days
Experimental: brentuximab vedotin + bendamustine
Biological: brentuximab vedotin
Specified Dose on Specified Days

Biological: bendamustine
Specified Dose on Specified Days
outcome measures
Primary Outcome Measures: 1. Event Free Survival (EFS) [ Time Frame: Up to 5 years ]
Low Risk Group. Based on blinded independent central review (BICR)
2. Complete Metabolic Response (CMR) rate prior to HDCT/ASCT [ Time Frame: 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.
3. Complete Metabolic Response (CMR) rate at any time prior to radiation therapy [ Time Frame: 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.
Secondary Outcome Measures: 1. Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment [ Time Frame: Up to 12 weeks ]
Based on blinded independent central review (BICR)
2. Progression Free Survival Rate (PFSR) [ Time Frame: Up to 5 years ]
Based on the blinded independent central review (BICR)
3. Duration of Response (DOR) [ Time Frame: Up to 5 years ]
Based on the blinded independent central review (BICR)
4. Incidence of serious and non-serious adverse events of nivolumab (BMS-936558) and brentuximab when given in combination. [ Time Frame: Up to 5 years ]
measured by number of patients
5. Incidence of clinically significant abnormalities in general laboratory tests of nivolumab (BMS-936558) and brentuximab when given in combination. [ Time Frame: Up to 5 years ]
Hematology, Chemistry and Urinalysis
6. Incidence of clinically significant vital sign measurements of nivolumab (BMS-936558) and brentuximab when given in combination. [ Time Frame: Up to 5 years ]
Temperature, Blood Pressure and Heart Rate
7. Complete Metabolic Response (CMR) rate prior to HDCT/ASCT [ Time Frame: 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.
8. Complete Metabolic Response (CMR) rate at any time prior to radiation therapy [ Time Frame: Up to 5 years ]
Low Risk Group. This is the rate prior to radiation therapy based on investigator assessments using Lugano 2014 criteria.
9. Event Free Survival (EFS) [ Time Frame: Up to 5 years ]
Low Risk Group. Based on investigator assessments
10. Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment [ Time Frame: Up to 12 weeks ]
Both Risk Groups. Based on investigator assessments
11. Progression Free Survival Rate (PFSR) [ Time Frame: Up to 5 years ]
Both Risk Groups. Based on investigator assessments
12. Duration of Response (DOR) [ Time Frame: Up to 5 years ]
Both Risk Groups. Based on investigator assessments

Eligibility Criteria
Ages Eligible for Study: 5 to 30 Years (Child, Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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


Contacts and Locations
Contacts
Locations
United States, Alabama Children's Hospital of Alabama Birmingham
United States, Arizona Phoenix Children'S Hospital Phoenix
United States, California Loma Linda University Cancer Center Loma Linda
United States, California Valley Children's Hospital Madera
United States, California Children'S Hospital & Research Center At Oakland Oakland
United States, California Children'S Hospital Of Orange County Orange
United States, California Lucile Packard Children'S Research Hospital/Stanford Univ Palo Alto
United States, California Local Institution - 0091 San Diego
United States, Colorado Childrens Hospital of Colorado Aurora
United States, Connecticut Smilow Cancer Hospital At Yale New Haven Hospital New Haven
United States, Delaware Nemours / A. I. duPont Hospital for Children Wilmington
United States, District of Columbia Children'S National Medical Center Washington
United States, Florida Nemours Children'S Clinic Jacksonville
United States, Florida Local Institution - 0069 Saint Petersburg
United States, Georgia Children's Healthcare Of Atlanta Atlanta
United States, Iowa University Of Iowa Iowa City
United States, Maryland John Hopkins University Baltimore
United States, Massachusetts Dana Farber Cancer Institute. Boston
United States, Mississippi University Of Mississippi Medical Center Jackson
United States, Missouri Children'S Mercy Hospital And Clinics Kansas City
United States, Missouri Washington University School Of Medicine Saint Louis
United States, Nevada Nevada Cancer Research Foundation Las Vegas
United States, New Jersey Hackensack University Medical Center Hackensack
United States, New Jersey Rutgers Cancer Institute of New Jersey New Brunswick
United States, New York Roswell Park Cancer Institute Buffalo
United States, North Carolina Local Institution Chapel Hill
United States, North Carolina Carolinas Medical Center Charlotte
United States, Ohio Cincinnati Children'S Hospital Medical Center Cincinnati
United States, Ohio Nationwide Children'S Hospital Columbus
United States, Oklahoma University Of Oklahoma Health Sciences Center Oklahoma City
United States, Pennsylvania Penn State Milton S. Hershey Medical Center Hershey
United States, Pennsylvania Childrens Hospital Of Philadelphia Philadelphia
United States, Pennsylvania Childrens Hospital Of Pittsburgh Of Upmc Pittsburgh
United States, Tennessee Vanderbilt University Nashville
United States, Texas Dell Children'S Medical Center Of Central Texas Austin
United States, Texas Local Institution - 0071 Dallas
United States, Texas Baylor College Of Medicine Houston
United States, Utah Primary Children's Hospital Salt Lake City
United States, Virginia Children'S Hosp-Kings Daughter Norfolk
United States, Virginia Virginia Commonwealth University Richmond
United States, Washington Seattle Childrens Hospital Seattle
United States, Wisconsin Children'S Hospital Of Wisconsin Milwaukee
Canada, Alberta Local Institution Calgary
Canada, Ontario Local Institution Toronto
Canada, Quebec The Montreal Children's Hospital of the MUHC Montreal
Czechia Klinika detske hematologie a onkologie Praha 5
France Hôpital Jeanne de Flandre Lille
France CHU Lyon GH Est Lyon Cedex 08
France Hopital De La Timone Marseille Cedex 5
France Local Institution Nantes
France Hopital Enfants Armand Trousseau Paris
France Hopital Robert Debre Paris
France CHU de Toulouse - Hopital des Enfants Toulouse cedex 9
France CHRU Nancy - Hopital Brabois Enfant Vandoeuvre les Nancy
France Institut Gustave Roussy Villejuif Cedex
Germany Local Institution - 0056 Berlin
Germany Uniklinikum Giessen und Marburg Giessen
Germany Mhh Kinderklinik Hannover
Germany Local Institution - 0102 Muenchen
Ireland Local Institution Dublin
Italy Cro-Aviano Aviano (PN)
Italy Local Institution - 0020 Bologna
Italy Irccs Istituto G. Gaslini Genova
Italy Local Institution - 0019 Monza (mb)
Italy Ao Santobono - Pausilipon Napoli
Italy AOU Policlinico Umberto I Roma
Netherlands Local Institution Rotterdam
Netherlands Local Institution Utrecht
Poland Local Institution Gdansk
Poland Local Institution Krakow
Spain Local Institution - 0082 Barcelona
Spain Local Institution Madrid
United Kingdom, Greater London Local Institution London
United Kingdom, North Yorkshire Local Institution Leeds
United Kingdom, Yorkshire Local Institution Leeds
United Kingdom Local Institution Birmingham
United Kingdom Local Institution Glasgow
United Kingdom Local Institution Manchester
Sponsors and Collaborators
Bristol-Myers Squibb
Seagen Inc.
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Bristol-Myers Squibb
ClinicalTrials.gov Identifier : NCT02927769     
Other Study ID Numbers : CA209-744, 2016-002347-41
First Posted : October 7, 2016
Last Update Posted : September 1, 2022
Last Verified : August 2022
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms :
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases