CheckMate 812: A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant,

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03138499
Collaborator
Seagen Inc. (Industry), Ono Pharmaceutical Co. Ltd (Industry)
20
Enrollment
55
Locations
2
Arms
43.9
Actual Duration (Months)
0.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether an investigational immuno-therapy combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The participants of this trial will comprise of patients who have relapsed or did not respond to treatment and are not eligible for stem cell transplant

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: Nivolumab
  • Biological: Brentuximab vedotin
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized, Open-label, Phase 3 Trial of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Participants With Relapsed Refractory or Ineligible for Autologous Stem Cell Transplant (ASCT) Advanced Stage Classical Hodgkin Lymphoma (CheckMate 812: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 812)
Actual Study Start Date :
Jun 26, 2017
Actual Primary Completion Date :
Feb 22, 2021
Actual Study Completion Date :
Feb 22, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Module A

Nivolumab combined with Brentuximab

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • Biological: Brentuximab vedotin
    Specified dose on specified days
    Other Names:
  • Adcetris
  • Experimental: Module B

    Brentuximab alone

    Biological: Brentuximab vedotin
    Specified dose on specified days
    Other Names:
  • Adcetris
  • Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival (PFS) [Up to four years]

      To compare progression free survival of nivolumab + Brentuximab vedotin (BV) versus BV based on Blinded Independent Central Review (BICR) assessments

    Secondary Outcome Measures

    1. Complete Response Rate (CRR) [Up to four years]

      To compare the complete response rate of nivolumab + BV versus BV based on BICR assessments

    2. Objective Response Rate (ORR) [Up to four years]

      To assess objective response rate and duration of response based on BICR

    3. Duration of response (DOR) [Up to four years]

      To assess duration of response based on BICR

    4. Duration of complete response (DOCR) [Up to four years]

      To assess duration of complete response based on BICR

    5. Overall Survival (OS) [Up to four years]

      To assess overall survival of participants treated with nivolumab + BV versus BV

    6. Progression Free Survival (PFS) [Up to four years]

      To assess PFS based on investigator assessments

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

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

    Inclusion Criteria:
    • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

    • Participants must have a pathologic diagnosis of classical Hodgkin lymphoma (cHL) who are relapsed or refractory with one of the following:

    1. Autologous stem cell transplant (ASCT) ineligible patients
    1. Patients after failure of ASCT
    • Must have at least one lesion that is > 15 mm (1.5 cm) in the longest diameter and avid by Fluoro Deoxy Glucose (FDG) Positron Emission Tomography (PET) scan
    Exclusion Criteria:
    • Known central nervous system lymphoma

    • Participants with nodular lymphocyte-predominant Hodgkin lymphoma (HL)

    • Participants with known history of pancreatitis or progressive multifocal leukoencephalopathy (PML)

    Other protocol defined inclusion/exclusion criteria could apply

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Dr. Moh'd Khushman MD, Office ofMobileAlabamaUnited States36604
    2University Of Arkansas For Medical SciencesLittle RockArkansasUnited States72205
    3City of Hope National Medical CenterDuarteCaliforniaUnited States91010
    4Pacific Shores Medical GroupLong BeachCaliforniaUnited States90813
    5University of Southern CaliforniaLos AngelesCaliforniaUnited States90033
    6UCLA Clinical and Translational Research Center (CTRC)Los AngelesCaliforniaUnited States90095
    7Local InstitutionPalo AltoCaliforniaUnited States94304
    8UC Davis Comprehensive Cancer CenterSacramentoCaliforniaUnited States95817
    9University of California San DiegoSan DiegoCaliforniaUnited States92122
    10Hartford HealthCare Cancer Institute at The Hospital of Central ConnecticutPlainvilleConnecticutUnited States06062
    11MedStar Georgetown University Hospital (MGUH)WashingtonDistrict of ColumbiaUnited States20007
    12Baptist Cancer InstituteJacksonvilleFloridaUnited States32207
    13Miami Cancer Institute, Baptist Health South FloridaMiamiFloridaUnited States33176
    14Orlando Health, IncOrlandoFloridaUnited States32806
    15H. Lee Moffit Cancer center and research instituteTampaFloridaUnited States33612
    16Parkview Cancer CenterFort WayneIndianaUnited States46845
    17University of Kansas Cancer CenterWestwoodKansasUnited States66205
    18Louisville OncologyLouisvilleKentuckyUnited States40202
    19Tulane University Health Sciences CenterNew OrleansLouisianaUnited States70112
    20Ochsner Clinic FoundationNew OrleansLouisianaUnited States70121
    21Dana Farber/Harvard Cancer CenterBostonMassachusettsUnited States02215
    22Karmanos Cancer InstituteDetroitMichiganUnited States48201
    23Mercy Clinic Oncology and Hematology - JoplinJoplinMissouriUnited States64804
    24Mercy Medical Research InstituteSpringfieldMissouriUnited States65804
    25Memorial Sloan-Kettering Cancer Center (MSKCC) - Basking RidgeBasking RidgeNew JerseyUnited States07920
    26John Theurer Cancer Center, Hackensack University Medical CenterHackensackNew JerseyUnited States07601
    27Memorial Sloan Kettering Cancer Center MonmouthMiddletownNew JerseyUnited States07748
    28Roswell Park Cancer InstituteBuffaloNew YorkUnited States14263
    29Memorial Sloan Kettering Cancer CenterHarrisonNew YorkUnited States10604
    30Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States10065
    31Memorial Sloan-Kettering Cancer CenterNew YorkNew YorkUnited States10065
    32Memorial Sloan Kettering Cancer Center Rockville CentreRockville CentreNew YorkUnited States11570
    33Duke University Medical CenterDurhamNorth CarolinaUnited States27110
    34East Carolina University Brody School of Medicine(ECU)GreenvilleNorth CarolinaUnited States27834
    35Wake Forest University Health SciencesWinston-SalemNorth CarolinaUnited States27157
    36University of PennsylvaniaPhiladelphiaPennsylvaniaUnited States19104
    37Medical University of South CarolinaCharlestonSouth CarolinaUnited States29425
    38Bon Secours Saint Francis Cancer CenterGreenvilleSouth CarolinaUnited States29607
    39Greenville Health System Cancer InstituteSpartanburgSouth CarolinaUnited States29307
    40Center For Biomedical ResearchKnoxvilleTennesseeUnited States37909
    41UT Medical Center Cancer InstituteKnoxvilleTennesseeUnited States37920
    42Vanderbilt Ingram Cancer CenterNashvilleTennesseeUnited States37213
    43University of Texas Southwestern Medical CenterDallasTexasUnited States75390
    44The University of Texas MD Anderson Cancer Center-mergeHoustonTexasUnited States77030
    45Vista Oncology - East OlympiaOlympiaWashingtonUnited States98502
    46Swedish Cancer InstituteSeattleWashingtonUnited States98104
    47Local InstitutionNagoya-shiAichiJapan4600001
    48Local InstitutionNagoyaAichiJapan4648681
    49Local InstitutionFukuoka-shiFukuokaJapan8128582
    50Local InstitutionIseharaKanagawaJapan2591193
    51Local InstitutionSendai-shiMiyagiJapan9808574
    52Local InstitutionOsakasayahaOsakaJapan5898511
    53Local InstitutionChuo-kuTokyoJapan1040045
    54Local InstitutionKoto-kuTokyoJapan135-8550
    55Local InstitutionSan JuanPuerto Rico00918

    Sponsors and Collaborators

    • Bristol-Myers Squibb
    • Seagen Inc.
    • Ono Pharmaceutical Co. Ltd

    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:
    NCT03138499
    Other Study ID Numbers:
    • CA209-812
    • 2017-000847-41
    First Posted:
    May 3, 2017
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 16, 2021