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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 (CheckMate 744)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02927769
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
Seagen Inc.
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE October 6, 2016
First Posted Date  ICMJE October 7, 2016
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE March 27, 2017
Estimated Primary Completion Date March 27, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2018)
  • Event Free Survival (EFS) [ Time Frame: Up to 5 years ]
    Low Risk Group. Based on blinded independent central review (BICR)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 6, 2016)
  • Event Free Survival (EFS) [ Time Frame: Up to 5 years ]
    Low Risk Group. Based on blinded independent central review (BICR)
  • Complete Metabolic Response (CMR) rate [ 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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2018)
  • 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)
  • Progression Free Survival Rate (PFSR) [ Time Frame: Up to 5 years ]
    Based on the blinded independent central review (BICR)
  • Duration of Response (DOR) [ Time Frame: Up to 5 years ]
    Based on the blinded independent central review (BICR)
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • Event Free Survival (EFS) [ Time Frame: Up to 5 years ]
    Low Risk Group. Based on investigator assessments
  • 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
  • Progression Free Survival Rate (PFSR) [ Time Frame: Up to 5 years ]
    Both Risk Groups. Based on investigator assessments
  • Duration of Response (DOR) [ Time Frame: Up to 5 years ]
    Both Risk Groups. Based on investigator assessments
Original Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2016)
  • Overall Response Rate (ORR) [ Time Frame: Up to 12 weeks ]
    Based on blinded independent central review (BICR)
  • Progression Free Survival Rate (PFSR) [ Time Frame: Up to 5 years ]
    Based on the blinded independent central review (BICR)
  • Duration of Response (DOR) [ Time Frame: Up to 5 years ]
    Based on the blinded independent central review (BICR)
  • Incidence of serious and non-serious adverse events of nivolumab (BMS-936558) and brentuximab when given in combination. [ Time Frame: Up to 5 years ]
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hodgkin Disease
Intervention  ICMJE
  • Biological: Nivolumab
    Specified Dose on Specified Days
    Other Names:
    • BMS-936558
    • Opdivo
  • Biological: brentuximab vedotin
    Specified Dose on Specified Days
  • Biological: bendamustine
    Specified Dose on Specified Days
Study Arms  ICMJE
  • Experimental: Nivolumab + brentuximab vedotin
    Interventions:
    • Biological: Nivolumab
    • Biological: brentuximab vedotin
  • Experimental: brentuximab vedotin + bendamustine
    Interventions:
    • Biological: brentuximab vedotin
    • Biological: bendamustine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 6, 2016)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 27, 2024
Estimated Primary Completion Date March 27, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
Listed Location Countries  ICMJE Canada,   Czechia,   France,   Germany,   Ireland,   Italy,   Netherlands,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02927769
Other Study ID Numbers  ICMJE CA209-744
2016-002347-41 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Seagen Inc.
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP