Hodgkin's Disease Clinical Trial
— CheckMate 812Official 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)
Verified date | January 2024 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 23 |
Est. completion date | February 22, 2021 |
Est. primary completion date | February 22, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Japan | Local Institution | Sendai-shi | Miyagi |
Puerto Rico | Local Institution | San Juan | |
United States | Dana Farber/Harvard Cancer Center | Boston | Massachusetts |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Karmanos Cancer Institute | Detroit | Michigan |
United States | City of Hope National Medical Center | Duarte | California |
United States | Parkview Cancer Center | Fort Wayne | Indiana |
United States | Bon Secours Saint Francis Cancer Center | Greenville | South Carolina |
United States | The University of Texas MD Anderson Cancer Center-merge | Houston | Texas |
United States | Pacific Shores Medical Group | Long Beach | California |
United States | UCLA Clinical and Translational Research Center (CTRC) | Los Angeles | California |
United States | University of Southern California | Los Angeles | California |
United States | Vanderbilt Ingram Cancer Center | Nashville | Tennessee |
United States | Tulane University Health Sciences Center | New Orleans | Louisiana |
United States | Orlando Health, Inc | Orlando | Florida |
United States | Local Institution | Palo Alto | California |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Hartford Healthcare Cancer Institute at the Hospital of Central Connecticut | Plainville | Connecticut |
United States | UC Davis Comprehensive Cancer Center | Sacramento | California |
United States | University of California San Diego | San Diego | California |
United States | University of Kansas Cancer Center | Westwood | Kansas |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb | Ono Pharmaceutical Co. Ltd, Seagen Inc. |
United States, Japan, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival (PFS) | 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. | From randomization to date of death, or disease progression (up to approximately 45 months) | |
Secondary | Complete Response Rate (CRR): | 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). |
From randomization up to approximately 45 months | |
Secondary | Objective Response Rate (ORR) | 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). |
From randomization up to approximately 45 months | |
Secondary | Duration of Response (DOR) | 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). |
From randomization to date of documented progression or death (up to approximately 45 months) | |
Secondary | Duration of Complete Response (DOCR) | 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). |
From randomization to date of documented progression or death (up to approximately 45 months) | |
Secondary | Overall Survival (OS) | 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 | From randomization to the date of death (up to approximately 3 years 7 months) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01665768 -
Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma
|
Phase 2 | |
Completed |
NCT01188798 -
Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies
|
Phase 3 | |
Completed |
NCT00975975 -
Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer
|
Phase 2 | |
Completed |
NCT00150462 -
Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies
|
Phase 1 | |
Completed |
NCT00606437 -
Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants
|
Phase 1 | |
Completed |
NCT02856646 -
Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices
|
||
Completed |
NCT01458288 -
A Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 Alone or in Combination With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease
|
Phase 2 | |
Completed |
NCT00990587 -
Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy
|
Phase 1 | |
Completed |
NCT00469729 -
Efficacy and Safety Study of StemEx®, to Treat Subjects With High Risk Hematologic Malignancies, Following Myeloablative Therapy
|
Phase 2/Phase 3 | |
Terminated |
NCT00594308 -
In-Vivo Activated T-Cell Depletion to Prevent GVHD
|
N/A | |
Completed |
NCT00552825 -
Pulmonary Function at Presentation and Follow-up in Hemato-Oncology 3-7 Years Old Children
|
N/A | |
Completed |
NCT00165438 -
Pulmonary Function in Patients With Hodgkin's Disease Receiving Bleomycin-Based Chemotherapy
|
N/A | |
Terminated |
NCT00176930 -
Stem Cell Transplant for Hematological Malignancy
|
N/A | |
Recruiting |
NCT02007811 -
Open-label Clinical Trial to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates for Immune Reconstitution After Allogeneic Stem Cell Transplantation Measured as Response to a Antedated Single Vaccination
|
Phase 1/Phase 2 | |
Completed |
NCT01221857 -
Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies
|
Phase 1/Phase 2 | |
Completed |
NCT00665314 -
Evaluation of the Safety and Efficacy of the Addition of AMD3100 to a G-CSF Mobilization Regimen in Patients With Lymphoma (NHL and HD) and Multiple Myeloma (MM).
|
Phase 2 | |
Completed |
NCT00569842 -
Investigation of the Cylex® ImmuKnow® Assay
|
N/A | |
Completed |
NCT00284804 -
A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease
|
Phase 2 | |
Completed |
NCT00256191 -
Study of TPI 287 Administered Every 21 Days in Patients With Advanced Malignancies
|
Phase 1 | |
Completed |
NCT00396201 -
AMD3100 (Plerixafor) Added to a Mobilizing Regimen of Granulocyte-colony Stimulating Factor (G-CSF) to Increase the Number of Peripheral Blood Stem Cells (PBSCs) in Patients With Hodgkin's Disease
|
Phase 2 |