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 |
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Recruitment Status :
Terminated
(Insufficient enrollment.)
First Posted : May 3, 2017
Results First Posted : April 12, 2022
Last Update Posted : January 10, 2024
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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) |
| Actual Enrollment : | 23 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 : | June 26, 2017 |
| Actual Primary Completion Date : | February 22, 2021 |
| Actual Study Completion Date : | February 22, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Module A
Nivolumab combined with Brentuximab
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Biological: Nivolumab
Specified dose on specified days
Other Name: Opdivo Biological: Brentuximab vedotin Specified dose on specified days
Other Name: Adcetris |
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Experimental: Module B
Brentuximab alone
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Biological: Brentuximab vedotin
Specified dose on specified days
Other Name: Adcetris |
- Progression Free Survival (PFS) [ Time Frame: From randomization to date of death, or disease progression (up to approximately 45 months) ]Progression Free Survival (PFS) is defined as time from date of randomization to death, or disease progression per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method.
- Complete Response Rate (CRR): [ Time Frame: From randomization up to approximately 45 months ]
Complete Response Rate (CRR) is defined as the number of participants who have achieved complete response (Lugano 2014 classification) per investigator assessment. Complete response is considered a score of 1, 2, or 3.
Per the Lugano criteria:
Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake </= mediastinum; and 3 = uptake > mediastinum but </= liver) and PET-positive scans, as scores of 4 or 5 (where 4 = uptake moderately higher than liver; 5 = uptake markedly higher than liver and/or new lesions). Response on PET scans should be reported as complete metabolic response (CMR) partial metabolic response (PMR), SMD (stable metabolic disease), or PMD (progressive metabolic disease).
- Objective Response Rate (ORR) [ Time Frame: From randomization up to approximately 45 months ]
Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) (Lugano 2014 classification) per investigator assessment. Complete response is considered a score of 1, 2, or 3. Partial response is considered a score of 4 or 5.
Per the Lugano criteria:
Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake </= mediastinum; and 3 = uptake > mediastinum but </= liver) and PET-positive scans, as scores of 4 or 5 (where 4 = uptake moderately higher than liver; 5 = uptake markedly higher than liver and/or new lesions). Response on PET scans should be reported as complete metabolic response (CMR) partial metabolic response (PMR), SMD (stable metabolic disease), or PMD (progressive metabolic disease).
- Duration of Response (DOR) [ Time Frame: From randomization to date of documented progression or death (up to approximately 45 months) ]
The time from first response (Complete response (CR) or partial response (PR)) to the date of initial objectively documented progression (2014 Lugano classification) or death due to any cause per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method. Complete response is considered a score of 1, 2, or 3. Partial response is considered a score of 4 or 5.
Per the Lugano criteria:
Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake </= mediastinum; and 3 = uptake > mediastinum but </= liver) and PET-positive scans, as scores of 4 or 5 (where 4 = uptake moderately higher than liver; 5 = uptake markedly higher than liver and/or new lesions). Response on PET scans should be reported as complete metabolic response (CMR) partial metabolic response (PMR), SMD (stable metabolic disease), or PMD (progressive metabolic disease).
- Duration of Complete Response (DOCR) [ Time Frame: From randomization to date of documented progression or death (up to approximately 45 months) ]
Duration of complete response (DOR) is defined as the time from first complete response to the date of initial objectively documented progression (2014 Lugano classification) or death due to any cause per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method. Complete response is considered a score of 1, 2, or 3.
Per the Lugano criteria:
Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake </= mediastinum; and 3 = uptake > mediastinum but </= liver) and PET-positive scans, as scores of 4 or 5 (where 4 = uptake moderately higher than liver; 5 = uptake markedly higher than liver and/or new lesions). Response on PET scans should be reported as complete metabolic response (CMR) partial metabolic response (PMR), SMD (stable metabolic disease), or PMD (progressive metabolic disease).
- Overall Survival (OS) [ Time Frame: From randomization to the date of death (up to approximately 3 years 7 months) ]Overall Survival (OS) is defined as the time between the date of randomization and the date of death estimated using the Kaplan-Meier (KM) product-limit method
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
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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.
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
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| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Documents provided by 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 |
| Results First Posted: | April 12, 2022 |
| Last Update Posted: | January 10, 2024 |
| Last Verified: | January 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Nivolumab |
Brentuximab Vedotin Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Immunotoxins Immunoconjugates Immunologic Factors Physiological Effects of Drugs |