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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 January 2024 |
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Main ID: |
NCT03138499 |
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Date of registration:
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01/05/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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,
CheckMate 812 |
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Scientific title:
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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) |
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Date of first enrolment:
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June 26, 2017 |
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Target sample size:
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23 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03138499 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Czechia
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Hungary
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Italy
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Japan
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Puerto Rico
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Turkey
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United States
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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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:.
i) Autologous stem cell transplant (ASCT) ineligible patients.
ii) 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 apply.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hodgkin's Disease
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Intervention(s)
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Biological: Brentuximab vedotin
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Biological: Nivolumab
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Primary Outcome(s)
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Progression Free Survival (PFS)
[Time Frame: From randomization to date of death, or disease progression (up to approximately 45 months)]
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Secondary Outcome(s)
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Duration of Complete Response (DOCR)
[Time Frame: From randomization to date of documented progression or death (up to approximately 45 months)]
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Complete Response Rate (CRR):
[Time Frame: From randomization up to approximately 45 months]
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Duration of Response (DOR)
[Time Frame: From randomization to date of documented progression or death (up to approximately 45 months)]
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Overall Survival (OS)
[Time Frame: From randomization to the date of death (up to approximately 3 years 7 months)]
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Objective Response Rate (ORR)
[Time Frame: From randomization up to approximately 45 months]
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Secondary ID(s)
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2017-000847-41
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CA209-812
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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