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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)

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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

Study Description
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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 Intervention/treatment Phase
Hodgkin Disease Biological: Nivolumab Biological: brentuximab vedotin Biological: bendamustine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: 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)
Actual Study Start Date : March 27, 2017
Estimated Primary Completion Date : March 27, 2023
Estimated Study Completion Date : March 27, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nivolumab + brentuximab vedotin Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
  • BMS-936558
  • Opdivo

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
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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
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Information from the National Library of Medicine

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927769


Contacts
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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 #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Seagen Inc.
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02927769    
Other Study ID Numbers: CA209-744
2016-002347-41 ( EudraCT Number )
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Nivolumab
Bendamustine Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action