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,

Phase 3

Terminated

• Conditions: Hodgkin's Disease
• Interventions: Biological: Brentuximab vedotin; Biological: Nivolumab

• Registration Number: NCT03138499
• Lead Sponsor: Bristol-Myers Squibb

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 available

Study Timeline

• Study First Submitted: 2017-05-01
• Study First Submitted QC: 2017-05-01
• Study First Posted: 2017-05-03
• Study Start: 2017-06-26
• Primary Completion: 2021-02-22
• Study Completion: 2021-02-22
• Results First Submitted: 2022-02-11
• Results First Submitted QC: 2022-03-18
• Results First Posted: 2022-04-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Module B	Brentuximab vedotin	Brentuximab alone
Module A	Brentuximab vedotin	Nivolumab combined with Brentuximab
Module A	Nivolumab	Nivolumab combined with Brentuximab

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	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.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	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).
Overall Survival (OS)	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
Complete Response Rate (CRR):	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).
Duration of Response (DOR)	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)	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).

Trial Locations

Locations (20)

UCLA Clinical and Translational Research Center (CTRC); 🇺🇸 Los Angeles, California, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Dana Farber/Harvard Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

The University of Texas MD Anderson Cancer Center-merge; 🇺🇸 Houston, Texas, United States

Orlando Health, Inc; 🇺🇸 Orlando, Florida, United States

Parkview Cancer Center; 🇺🇸 Fort Wayne, Indiana, United States

UC Davis Comprehensive Cancer Center; 🇺🇸 Sacramento, California, United States

University of Kansas Cancer Center; 🇺🇸 Westwood, Kansas, United States

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

Pacific Shores Medical Group; 🇺🇸 Long Beach, California, United States

University of California San Diego; 🇺🇸 San Diego, California, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Local Institution; 🇵🇷 San Juan, Puerto Rico

Hartford Healthcare Cancer Institute at the Hospital of Central Connecticut; 🇺🇸 Plainville, Connecticut, United States

Vanderbilt Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Tulane University Health Sciences Center; 🇺🇸 New Orleans, Louisiana, United States

Bon Secours Saint Francis Cancer Center; 🇺🇸 Greenville, South Carolina, United States