Clinical trial NCT03138499: 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,
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hodgkin's Disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Seagen Inc.
name: Ono Pharmaceutical Co. Ltd
First posted: 2017-05-03
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From randomization to date of death, or disease progression (up to approximately 45 months)
Secondary outcomes:
measure: Complete Response Rate (CRR):
timeFrame: From randomization up to approximately 45 months
measure: Objective Response Rate (ORR)
timeFrame: From randomization up to approximately 45 months
measure: Duration of Response (DOR)
timeFrame: From randomization to date of documented progression or death (up to approximately 45 months)
measure: Duration of Complete Response (DOCR)
timeFrame: From randomization to date of documented progression or death (up to approximately 45 months)
measure: Overall Survival (OS)
timeFrame: From randomization to the date of death (up to approximately 3 years 7 months)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: UCLA Clinical and Translational Research Center (CTRC)
state: California
city: Palo Alto
country: United States
facility: Local Institution
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Plainville
country: United States
facility: Hartford Healthcare Cancer Institute at the Hospital of Central Connecticut
state: Connecticut
city: Orlando
country: United States
facility: Orlando Health, Inc
state: Florida
city: Fort Wayne
country: United States
facility: Parkview Cancer Center
state: Indiana
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Boston
country: United States
facility: Dana Farber/Harvard Cancer Center
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Greenville
country: United States
facility: Bon Secours Saint Francis Cancer Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Ingram Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center-merge
state: Texas
city: Sendai-shi
country: Japan
facility: Local Institution
state: Miyagi
city: San Juan
country: Puerto Rico
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: