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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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hodgkin's Disease | Biological: Nivolumab Biological: Brentuximab vedotin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 340 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 : | May 16, 2017 |
Estimated Primary Completion Date : | November 29, 2020 |
Estimated Study Completion Date : | July 27, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Module A
Nivolumab combined with Brentuximab
|
Biological: Nivolumab
Specified dose on specified days
Other Name: Opdivo Biological: Brentuximab vedotin Specified dose on specified days
Other Name: Adcetris |
Experimental: Module B
Brentuximab alone
|
Biological: Brentuximab vedotin
Specified dose on specified days
Other Name: Adcetris |
- 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
- Complete Response Rate (CRR) [ Time Frame: Up to four years ]To compare the complete response rate of nivolumab + BV versus BV based on BICR assessments
- Objective Response Rate (ORR) [ Time Frame: Up to four years ]To assess objective response rate and duration of response based on BICR
- Duration of response (DOR) [ Time Frame: Up to four years ]To assess duration of response based on BICR
- Duration of complete response (DOCR) [ Time Frame: Up to four years ]To assess duration of complete response based on BICR
- Overall Survival (OS) [ Time Frame: Up to four years ]To assess overall survival of participants treated with nivolumab + BV versus BV
- Progression Free Survival (PFS) [ Time Frame: Up to four years ]To assess PFS based on investigator assessments

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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:
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 could apply

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): NCT03138499

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT03138499 |
Other Study ID Numbers: |
CA209-812 2017-000847-41 ( EudraCT Number ) |
First Posted: | May 3, 2017 Key Record Dates |
Last Update Posted: | August 11, 2020 |
Last Verified: | August 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Nivolumab Antineoplastic Agents, Immunological Antineoplastic Agents |