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

Arms and interventions

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)
• Primary Outcome Measures: 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.
• Primary Outcome Measures: 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)
• Secondary Outcome Measures: 2. Progression Free Survival Rate (PFSR) [ Time Frame: Up to 5 years ]
  Based on the blinded independent central review (BICR)
• Secondary Outcome Measures: 3. Duration of Response (DOR) [ Time Frame: Up to 5 years ]
  Based on the blinded independent central review (BICR)
• Secondary Outcome Measures: 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
• Secondary Outcome Measures: 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
• Secondary Outcome Measures: 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
• Secondary Outcome Measures: 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.
• Secondary Outcome Measures: 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.
• Secondary Outcome Measures: 9. Event Free Survival (EFS) [ Time Frame: Up to 5 years ]
  Low Risk Group. Based on investigator assessments
• Secondary Outcome Measures: 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
• Secondary Outcome Measures: 11. Progression Free Survival Rate (PFSR) [ Time Frame: Up to 5 years ]
  Both Risk Groups. Based on investigator assessments
• Secondary Outcome Measures: 12. Duration of Response (DOR) [ Time Frame: Up to 5 years ]
  Both Risk Groups. Based on investigator assessments

Eligibility Criteria

Information from the National Library of Medicine

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

More Information

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02927769 History of Changes
• Other Study ID Numbers: CA209-744, 2016-002347-41
• First Posted: October 7, 2016 Key Record Dates
• Last Update Posted: July 22, 2022
• Last Verified: July 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