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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ClinicalTrials.gov Identifier: NCT03138499 |
Recruitment Status :
Active, not recruiting
First Posted : May 3, 2017
Last Update Posted : August 11, 2020
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Sponsor:
Bristol-Myers Squibb
Collaborators:
Seagen Inc.
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
Tracking Information | |||||
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First Submitted Date ICMJE | May 1, 2017 | ||||
First Posted Date ICMJE | May 3, 2017 | ||||
Last Update Posted Date | August 11, 2020 | ||||
Actual Study Start Date ICMJE | May 16, 2017 | ||||
Estimated Primary Completion Date | November 29, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Progression Free Survival (PFS) [ Time Frame: Up to four years ] To compare progression free survival of nivolumab + Brentuximab vedotin (BV) versus BV based on Blinded Independent Central Review (BICR) assessments
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
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 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, | ||||
Official Title ICMJE | 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) | ||||
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 | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hodgkin's Disease | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
340 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 27, 2023 | ||||
Estimated Primary Completion Date | November 29, 2020 (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:
I. Autologous stem cell transplant (ASCT) ineligible patients ii. Patients after failure of ASCT
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Japan, Puerto Rico, United States | ||||
Removed Location Countries | Australia, Czechia, Hungary, Italy, Turkey | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT03138499 | ||||
Other Study ID Numbers ICMJE | CA209-812 2017-000847-41 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Bristol-Myers Squibb | ||||
Study Sponsor ICMJE | Bristol-Myers Squibb | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Bristol-Myers Squibb | ||||
Verification Date | August 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |