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CheckMate 744: 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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02927769
Collaborator
Seagen Inc. (Industry)
72
Enrollment
78
Locations
2
Arms
91.5
Anticipated Duration (Months)
0.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
  • Biological: Nivolumab
  • Biological: brentuximab vedotin
  • Biological: bendamustine
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
72 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 :
Mar 28, 2017
Anticipated Primary Completion Date :
Jan 6, 2024
Anticipated Study Completion Date :
Nov 10, 2024

Arms and Interventions

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

    Primary Outcome Measures

    1. Event Free Survival (EFS) [Up to 5 years]

      Low Risk Group. Based on blinded independent central review (BICR)

    2. Complete Metabolic Response (CMR) rate prior to HDCT/ASCT [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 [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 [Up to 12 weeks]

      Based on blinded independent central review (BICR)

    2. Progression Free Survival Rate (PFSR) [Up to 5 years]

      Based on the blinded independent central review (BICR)

    3. Duration of Response (DOR) [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. [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. [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. [Up to 5 years]

      Temperature, Blood Pressure and Heart Rate

    7. Complete Metabolic Response (CMR) rate prior to HDCT/ASCT [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 [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) [Up to 5 years]

      Low Risk Group. Based on investigator assessments

    10. Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment [Up to 12 weeks]

      Both Risk Groups. Based on investigator assessments

    11. Progression Free Survival Rate (PFSR) [Up to 5 years]

      Both Risk Groups. Based on investigator assessments

    12. Duration of Response (DOR) [Up to 5 years]

      Both Risk Groups. Based on investigator assessments

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Alabama Birmingham Alabama United States 35233
    2 Phoenix Children'S Hospital Phoenix Arizona United States 85016
    3 Loma Linda University Cancer Center Loma Linda California United States 92350
    4 Southern California Permanente Medical Group Los Angeles California United States 90027
    5 Valley Children's Hospital Madera California United States 93636
    6 Children'S Hospital & Research Center At Oakland Oakland California United States 94609
    7 Children'S Hospital Of Orange County Orange California United States 92868
    8 Lucile Packard Children'S Research Hospital/Stanford Univ Palo Alto California United States 94304
    9 Childrens Hospital of Colorado Aurora Colorado United States 80045
    10 Smilow Cancer Hospital At Yale New Haven Hospital New Haven Connecticut United States 06520
    11 Nemours / A. I. duPont Hospital for Children Wilmington Delaware United States 19803
    12 Children'S National Medical Center Washington District of Columbia United States 20010
    13 Nemours Children'S Clinic Jacksonville Florida United States 32207
    14 Local Institution - 0069 Saint Petersburg Florida United States 33701
    15 Children's Healthcare Of Atlanta Atlanta Georgia United States 30322
    16 University Of Iowa Iowa City Iowa United States 52242
    17 John Hopkins University Baltimore Maryland United States 21287
    18 Dana Farber Cancer Institute. Boston Massachusetts United States 02215
    19 University Of Mississippi Medical Center Jackson Mississippi United States 39216
    20 Children'S Mercy Hospital And Clinics Kansas City Missouri United States 64108
    21 Washington University School Of Medicine Saint Louis Missouri United States 63110
    22 Nevada Cancer Research Foundation Las Vegas Nevada United States 89135
    23 Hackensack University Medical Center Hackensack New Jersey United States 07601-1914
    24 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    25 Roswell Park Cancer Institute Buffalo New York United States 14263
    26 Local Institution Chapel Hill North Carolina United States 27599
    27 Carolinas Medical Center Charlotte North Carolina United States 28203
    28 Cincinnati Children'S Hospital Medical Center Cincinnati Ohio United States 45229-3039
    29 Nationwide Children'S Hospital Columbus Ohio United States 43205
    30 University Of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    31 Penn State Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    32 Childrens Hospital Of Philadelphia Philadelphia Pennsylvania United States 19104
    33 Childrens Hospital Of Pittsburgh Of Upmc Pittsburgh Pennsylvania United States 15224
    34 Vanderbilt University Nashville Tennessee United States 37232-6310
    35 Dell Children'S Medical Center Of Central Texas Austin Texas United States 78723
    36 Local Institution - 0071 Dallas Texas United States 75235
    37 Baylor College Of Medicine Houston Texas United States 77030
    38 Primary Children's Hospital Salt Lake City Utah United States 84113
    39 Children'S Hosp-Kings Daughter Norfolk Virginia United States 23507-1910
    40 Virginia Commonwealth University Richmond Virginia United States 23219
    41 Seattle Childrens Hospital Seattle Washington United States 98105
    42 Children'S Hospital Of Wisconsin Milwaukee Wisconsin United States 53226
    43 Local Institution Calgary Alberta Canada T3B 6A8
    44 Local Institution Toronto Ontario Canada M5G 1X8
    45 The Montreal Children's Hospital of the MUHC Montreal Quebec Canada H4A 3J1
    46 Klinika detske hematologie a onkologie Praha 5 Czechia 150 06
    47 Hôpital Jeanne de Flandre Lille France 59037
    48 CHU Lyon GH Est Lyon Cedex 08 France 69008
    49 Hopital De La Timone Marseille Cedex 5 France 13385
    50 Local Institution Nantes France 44093
    51 Hopital Enfants Armand Trousseau Paris France 75012
    52 Hopital Robert Debre Paris France 75019
    53 CHU de Toulouse - Hopital des Enfants Toulouse cedex 9 France 31059
    54 CHRU Nancy - Hopital Brabois Enfant Vandoeuvre les Nancy France 54500
    55 Institut Gustave Roussy Villejuif Cedex France 94805
    56 Local Institution - 0056 Berlin Germany 13353
    57 Uniklinikum Giessen und Marburg Giessen Germany 35392
    58 Mhh Kinderklinik Hannover Germany 30625
    59 Local Institution - 0102 Muenchen Germany 80337
    60 Local Institution Dublin Ireland 8
    61 Cro-Aviano Aviano (PN) Italy 33081
    62 Local Institution - 0020 Bologna Italy 40138
    63 Irccs Istituto G. Gaslini Genova Italy 16147
    64 Local Institution - 0019 Monza (mb) Italy 20900
    65 Ao Santobono - Pausilipon Napoli Italy 80123
    66 AOU Policlinico Umberto I Roma Italy 00161
    67 Local Institution Rotterdam Netherlands 3015 CN
    68 Local Institution Utrecht Netherlands 3584 CS
    69 Local Institution Gdansk Poland 80-952
    70 Local Institution Krakow Poland 30-663
    71 Local Institution Esplugues de Llobregat Spain 08950
    72 Local Institution Madrid Spain 28009
    73 Local Institution London Greater London United Kingdom NW1 2PG
    74 Local Institution Leeds North Yorkshire United Kingdom LS1 3EX
    75 Local Institution Leeds Yorkshire United Kingdom LS9 7TF
    76 Local Institution Birmingham United Kingdom B15 2TH
    77 Local Institution Glasgow United Kingdom G51 4TF
    78 Local Institution Manchester United Kingdom M13 9WL

    Sponsors and Collaborators

    • Bristol-Myers Squibb
    • Seagen Inc.

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02927769
    Other Study ID Numbers:
    • CA209-744
    • 2016-002347-41
    First Posted:
    Oct 7, 2016
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 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
    Nivolumab
    Brentuximab Vedotin
    Bendamustine Hydrochloride

    Study Results

    No Results Posted as of Jul 22, 2022