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,

Hodgkin's Disease Clinical Trial

— CheckMate 812  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03138499
• Other study ID #: CA209-812
• Secondary ID: 2017-000847-41
• Status: Terminated
• Phase: Phase 3
• Start date: June 26, 2017
• Est. completion date: February 22, 2021

Study information

• Verified date: January 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Disease

Intervention

Biological:
• Nivolumab
Specified dose on specified days
• Brentuximab vedotin
Specified dose on specified days

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd, Seagen Inc.

Countries where clinical trial is conducted

United States,  Japan,  Puerto Rico, 

Outcome

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	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	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	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	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)

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