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A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Relapsed or Refractory From First Line Treatment (CheckMate 744)

Primary Purpose

Hodgkin Disease

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nivolumab
brentuximab vedotin
bendamustine
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Disease

Eligibility Criteria

5 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Classic Hodgkin Lymphoma (cHL), relapsed or refractory
  • Minimal limitation on activities of daily living as measured by Karnofsky ≥ 50 for participants > 16 years of age or Lansky ≥ 50 for participants ≤ 16 years of age.
  • One prior anti-cancer therapy that did not work

Exclusion Criteria:

  • Active, known, or suspected autoimmune disease or infection
  • Active cerebral/meningeal disease related to the underlying malignancy
  • More than one line of anti-cancer therapy or no treatment at all
  • Received a stem cell transplant for Hodgkin Lymphoma and/or a solid organ transplant
  • Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)

Other protocol defined inclusion/exclusion criteria apply

Sites / Locations

  • Children's Hospital of Alabama
  • Phoenix Children'S Hospital
  • Loma Linda University Cancer Center
  • Valley Children's Hospital
  • Children'S Hospital & Research Center At Oakland
  • Children'S Hospital Of Orange County
  • Lucile Packard Children'S Research Hospital/Stanford Univ
  • Local Institution - 0091
  • Childrens Hospital of Colorado
  • Smilow Cancer Hospital At Yale New Haven Hospital
  • Nemours / A. I. duPont Hospital for Children
  • Children'S National Medical Center
  • Local Institution - 0062
  • Local Institution - 0069
  • Children's Healthcare Of Atlanta
  • University Of Iowa
  • Local Institution - 0070
  • Dana Farber Cancer Institute.
  • Local Institution - 0097
  • Local Institution - 0049
  • Local Institution - 0085
  • Washington University School Of Medicine
  • Nevada Cancer Research Foundation
  • Hackensack University Medical Center
  • Rutgers Cancer Institute of New Jersey
  • Local Institution - 0068
  • Local Institution
  • Carolinas Medical Center
  • Cincinnati Children'S Hospital Medical Center
  • Local Institution - 0089
  • University Of Oklahoma Health Sciences Center
  • Local Institution - 0090
  • Childrens Hospital Of Philadelphia
  • Childrens Hospital Of Pittsburgh Of Upmc
  • Vanderbilt University
  • Local Institution - 0042
  • Local Institution - 0071
  • Baylor College Of Medicine
  • Primary Children's Hospital
  • Children'S Hosp-Kings Daughter
  • Virginia Commonwealth University
  • Local Institution - 0048
  • Local Institution - 0065
  • Local Institution
  • Local Institution
  • The Montreal Children's Hospital of the MUHC
  • Klinika detske hematologie a onkologie
  • Local Institution - 0034
  • Hôpital Jeanne de Flandre
  • CHU Lyon GH Est
  • Local Institution - 0032
  • Local Institution
  • Local Institution - 0031
  • Local Institution - 0026
  • CHU de Toulouse - Hopital des Enfants
  • Local Institution - 0027
  • Local Institution - 0056
  • Local Institution - 0055
  • Local Institution - 0057
  • Local Institution - 0102
  • Local Institution - 0017
  • Local Institution - 0024
  • Local Institution - 0020
  • Irccs Istituto G. Gaslini
  • Local Institution - 0019
  • Local Institution - 0023
  • Local Institution - 0022
  • Local Institution
  • Local Institution - 0006
  • Local Institution
  • Local Institution
  • Local Institution - 0082
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution - 0002
  • Local Institution - 0012

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nivolumab + brentuximab vedotin

brentuximab vedotin + bendamustine

Arm Description

Outcomes

Primary Outcome Measures

Event Free Survival (EFS)
Low Risk Group. Based on blinded independent central review (BICR)
Complete Metabolic Response (CMR) rate prior to HDCT/ASCT
Standard Risk Group. This is the rate prior to high-dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) based on the blinded independent central review (BICR) using Lugano 2014 criteria.
Complete Metabolic Response (CMR) rate at any time prior to radiation therapy
Low Risk Group. The CMR rate is defined as the proportion of all response-evaluable participants who, assessed by the BICR, achieve best response of CMR using Lugano 2014 criteria.

Secondary Outcome Measures

Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment
Based on blinded independent central review (BICR)
Progression Free Survival Rate (PFSR)
Based on the blinded independent central review (BICR)
Duration of Response (DOR)
Based on the blinded independent central review (BICR)
Incidence of serious and non-serious adverse events of nivolumab (BMS-936558) and brentuximab when given in combination.
measured by number of patients
Incidence of clinically significant abnormalities in general laboratory tests of nivolumab (BMS-936558) and brentuximab when given in combination.
Hematology, Chemistry and Urinalysis
Incidence of clinically significant vital sign measurements of nivolumab (BMS-936558) and brentuximab when given in combination.
Temperature, Blood Pressure and Heart Rate
Complete Metabolic Response (CMR) rate prior to HDCT/ASCT
Standard Risk Group. This is the rate prior to high-dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) based on investigator assessments using Lugano 2014 criteria.
Complete Metabolic Response (CMR) rate at any time prior to radiation therapy
Low Risk Group. This is the rate prior to radiation therapy based on investigator assessments using Lugano 2014 criteria.
Event Free Survival (EFS)
Low Risk Group. Based on investigator assessments
Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment
Both Risk Groups. Based on investigator assessments
Progression Free Survival Rate (PFSR)
Both Risk Groups. Based on investigator assessments
Duration of Response (DOR)
Both Risk Groups. Based on investigator assessments

Full Information

First Posted
October 6, 2016
Last Updated
October 4, 2023
Sponsor
Bristol-Myers Squibb
Collaborators
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02927769
Brief Title
A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Relapsed or Refractory From First Line Treatment
Acronym
CheckMate 744
Official Title
Risk-based, Response-adapted, Phase II Open-label Trial of Nivolumab + Brentuximab Vedotin (N + Bv) for Children, Adolescents, and Young Adults With Relapsed/Refractory (R/R) CD30 + Classic Hodgkin Lymphoma (cHL) After Failure of First-line Therapy, Followed by Brentuximab + Bendamustine (Bv + B) for Participants With a Suboptimal Response (CheckMate 744: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 28, 2017 (Actual)
Primary Completion Date
January 8, 2024 (Anticipated)
Study Completion Date
November 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Seagen Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether nivolumab plus brentuximab vedotin (followed by brentuximab vedotin plus bendamustine in patient with suboptimal response) is safe and effective in treating patients with Hodgkin's lymphoma (cHL). Eligible patients are children, adolescents, and young adults relapsed or refractory to first line.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab + brentuximab vedotin
Arm Type
Experimental
Arm Title
brentuximab vedotin + bendamustine
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558, Opdivo
Intervention Description
Specified Dose on Specified Days
Intervention Type
Biological
Intervention Name(s)
brentuximab vedotin
Intervention Description
Specified Dose on Specified Days
Intervention Type
Biological
Intervention Name(s)
bendamustine
Intervention Description
Specified Dose on Specified Days
Primary Outcome Measure Information:
Title
Event Free Survival (EFS)
Description
Low Risk Group. Based on blinded independent central review (BICR)
Time Frame
Up to 5 years
Title
Complete Metabolic Response (CMR) rate prior to HDCT/ASCT
Description
Standard Risk Group. This is the rate prior to high-dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) based on the blinded independent central review (BICR) using Lugano 2014 criteria.
Time Frame
Up to 5 years
Title
Complete Metabolic Response (CMR) rate at any time prior to radiation therapy
Description
Low Risk Group. The CMR rate is defined as the proportion of all response-evaluable participants who, assessed by the BICR, achieve best response of CMR using Lugano 2014 criteria.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment
Description
Based on blinded independent central review (BICR)
Time Frame
Up to 12 weeks
Title
Progression Free Survival Rate (PFSR)
Description
Based on the blinded independent central review (BICR)
Time Frame
Up to 5 years
Title
Duration of Response (DOR)
Description
Based on the blinded independent central review (BICR)
Time Frame
Up to 5 years
Title
Incidence of serious and non-serious adverse events of nivolumab (BMS-936558) and brentuximab when given in combination.
Description
measured by number of patients
Time Frame
Up to 5 years
Title
Incidence of clinically significant abnormalities in general laboratory tests of nivolumab (BMS-936558) and brentuximab when given in combination.
Description
Hematology, Chemistry and Urinalysis
Time Frame
Up to 5 years
Title
Incidence of clinically significant vital sign measurements of nivolumab (BMS-936558) and brentuximab when given in combination.
Description
Temperature, Blood Pressure and Heart Rate
Time Frame
Up to 5 years
Title
Complete Metabolic Response (CMR) rate prior to HDCT/ASCT
Description
Standard Risk Group. This is the rate prior to high-dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) based on investigator assessments using Lugano 2014 criteria.
Time Frame
Up to 5 years
Title
Complete Metabolic Response (CMR) rate at any time prior to radiation therapy
Description
Low Risk Group. This is the rate prior to radiation therapy based on investigator assessments using Lugano 2014 criteria.
Time Frame
Up to 5 years
Title
Event Free Survival (EFS)
Description
Low Risk Group. Based on investigator assessments
Time Frame
Up to 5 years
Title
Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment
Description
Both Risk Groups. Based on investigator assessments
Time Frame
Up to 12 weeks
Title
Progression Free Survival Rate (PFSR)
Description
Both Risk Groups. Based on investigator assessments
Time Frame
Up to 5 years
Title
Duration of Response (DOR)
Description
Both Risk Groups. Based on investigator assessments
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Classic Hodgkin Lymphoma (cHL), relapsed or refractory Minimal limitation on activities of daily living as measured by Karnofsky ≥ 50 for participants > 16 years of age or Lansky ≥ 50 for participants ≤ 16 years of age. One prior anti-cancer therapy that did not work Exclusion Criteria: Active, known, or suspected autoimmune disease or infection Active cerebral/meningeal disease related to the underlying malignancy More than one line of anti-cancer therapy or no treatment at all Received a stem cell transplant for Hodgkin Lymphoma and/or a solid organ transplant Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors) Other protocol defined inclusion/exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Phoenix Children'S Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Loma Linda University Cancer Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Facility Name
Valley Children's Hospital
City
Madera
State/Province
California
ZIP/Postal Code
93636
Country
United States
Facility Name
Children'S Hospital & Research Center At Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Children'S Hospital Of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Lucile Packard Children'S Research Hospital/Stanford Univ
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Local Institution - 0091
City
San Diego
State/Province
California
ZIP/Postal Code
92109
Country
United States
Facility Name
Childrens Hospital of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Smilow Cancer Hospital At Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Nemours / A. I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Children'S National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Local Institution - 0062
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Local Institution - 0069
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Children's Healthcare Of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University Of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Local Institution - 0070
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Dana Farber Cancer Institute.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0097
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Local Institution - 0049
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Local Institution - 0085
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Washington University School Of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601-1914
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Local Institution - 0068
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Local Institution
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Cincinnati Children'S Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Local Institution - 0089
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
University Of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Local Institution - 0090
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Childrens Hospital Of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Childrens Hospital Of Pittsburgh Of Upmc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6310
Country
United States
Facility Name
Local Institution - 0042
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
Local Institution - 0071
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor College Of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Children'S Hosp-Kings Daughter
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1910
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Local Institution - 0048
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Local Institution - 0065
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Local Institution
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
The Montreal Children's Hospital of the MUHC
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Klinika detske hematologie a onkologie
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Local Institution - 0034
City
Vandoeuvre lès Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54511
Country
France
Facility Name
Hôpital Jeanne de Flandre
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Lyon GH Est
City
Lyon Cedex 08
ZIP/Postal Code
69008
Country
France
Facility Name
Local Institution - 0032
City
Marseille
ZIP/Postal Code
13011
Country
France
Facility Name
Local Institution
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution - 0031
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Local Institution - 0026
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
CHU de Toulouse - Hopital des Enfants
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution - 0027
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Local Institution - 0056
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Local Institution - 0055
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Local Institution - 0057
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution - 0102
City
Muenchen
ZIP/Postal Code
80337
Country
Germany
Facility Name
Local Institution - 0017
City
Dublin
ZIP/Postal Code
Dublin 8
Country
Ireland
Facility Name
Local Institution - 0024
City
Aviano (PN)
ZIP/Postal Code
33081
Country
Italy
Facility Name
Local Institution - 0020
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Irccs Istituto G. Gaslini
City
Genova
ZIP/Postal Code
16147
Country
Italy
Facility Name
Local Institution - 0019
City
Monza (mb)
ZIP/Postal Code
20900
Country
Italy
Facility Name
Local Institution - 0023
City
Napoli
ZIP/Postal Code
80123
Country
Italy
Facility Name
Local Institution - 0022
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Local Institution
City
Rotterdam
ZIP/Postal Code
3015 CN
Country
Netherlands
Facility Name
Local Institution - 0006
City
Utrecht
ZIP/Postal Code
3584 CS
Country
Netherlands
Facility Name
Local Institution
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
30-663
Country
Poland
Facility Name
Local Institution - 0082
City
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Local Institution
City
Leeds
State/Province
North Yorkshire
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Local Institution
City
Leeds
State/Province
Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Local Institution
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Local Institution
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Local Institution - 0002
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
Local Institution - 0012
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Relapsed or Refractory From First Line Treatment

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