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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

NCT02927769

Description:

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.

Related Conditions:
  • Classical Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief 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
  • Official Title: Risk-based, Response-adapted, Phase II Open-label Trial of Nivolumab + Brentuximab Vedotin (N + Bv) for Children, Adolescents, and Young Adults With Relapsed/Refractory (R/R) CD30 + Classic Hodgkin Lymphoma (cHL) After Failure of First-line Therapy, Followed by Brentuximab + Bendamustine (Bv + B) for Participants With a Suboptimal Response (CheckMate 744: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation)

Clinical Trial IDs

  • ORG STUDY ID: CA209-744
  • SECONDARY ID: 2016-002347-41
  • NCT ID: NCT02927769

Conditions

  • Hodgkin Disease

Interventions

DrugSynonymsArms
NivolumabBMS-936558, OpdivoNivolumab + brentuximab vedotin
brentuximab vedotinNivolumab + brentuximab vedotin
bendamustinebrentuximab vedotin + bendamustine

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Nivolumab + brentuximab vedotinExperimental
  • Nivolumab
  • brentuximab vedotin
brentuximab vedotin + bendamustineExperimental
  • brentuximab vedotin
  • bendamustine

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        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 could apply
      
Maximum Eligible Age:30 Years
Minimum Eligible Age:5 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Event Free Survival (EFS)
Time Frame:Up to 5 years
Safety Issue:
Description:Low Risk Group. Based on blinded independent central review (BICR)

Secondary Outcome Measures

Measure:Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment
Time Frame:Up to 12 weeks
Safety Issue:
Description:Based on blinded independent central review (BICR)
Measure:Progression Free Survival Rate (PFSR)
Time Frame:Up to 5 years
Safety Issue:
Description:Based on the blinded independent central review (BICR)
Measure:Duration of Response (DOR)
Time Frame:Up to 5 years
Safety Issue:
Description:Based on the blinded independent central review (BICR)
Measure:Incidence of serious and non-serious adverse events of nivolumab (BMS-936558) and brentuximab when given in combination.
Time Frame:Up to 5 years
Safety Issue:
Description:measured by number of patients
Measure: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
Safety Issue:
Description:Hematology, Chemistry and Urinalysis
Measure:Incidence of clinically significant vital sign measurements of nivolumab (BMS-936558) and brentuximab when given in combination.
Time Frame:Up to 5 years
Safety Issue:
Description:Temperature, Blood Pressure and Heart Rate
Measure:Complete Metabolic Response (CMR) rate prior to HDCT/ASCT
Time Frame:Up to 5 years
Safety Issue:
Description: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.
Measure:Complete Metabolic Response (CMR) rate at any time prior to radiation therapy
Time Frame:Up to 5 years
Safety Issue:
Description:Low Risk Group. This is the rate prior to radiation therapy based on investigator assessments using Lugano 2014 criteria.
Measure:Event Free Survival (EFS)
Time Frame:Up to 5 years
Safety Issue:
Description:Low Risk Group. Based on investigator assessments
Measure:Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment
Time Frame:Up to 12 weeks
Safety Issue:
Description:Both Risk Groups. Based on investigator assessments
Measure:Progression Free Survival Rate (PFSR)
Time Frame:Up to 5 years
Safety Issue:
Description:Both Risk Groups. Based on investigator assessments
Measure:Duration of Response (DOR)
Time Frame:Up to 5 years
Safety Issue:
Description:Both Risk Groups. Based on investigator assessments

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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