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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02927769

Recruitment Status : Recruiting

First Posted : October 7, 2016

Last Update Posted : June 11, 2020

See Contacts and Locations

Sponsor:

Collaborator:

Seagen Inc.

Information provided by (Responsible Party):

Bristol-Myers Squibb

Tracking Information

First Submitted Date ^ICMJE

October 6, 2016

First Posted Date ^ICMJE

October 7, 2016

Last Update Posted Date

June 11, 2020

Actual Study Start Date ^ICMJE

March 27, 2017

Estimated Primary Completion Date

March 27, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Event Free Survival (EFS) [ Time Frame: Up to 5 years ]
Low Risk Group. Based on blinded independent central review (BICR)
Complete Metabolic Response (CMR) rate prior to HDCT/ASCT [ Time Frame: Up to 5 years ]
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 [ Time Frame: Up to 5 years ]
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.

Original Primary Outcome Measures ^ICMJE

Event Free Survival (EFS) [ Time Frame: Up to 5 years ]
Low Risk Group. Based on blinded independent central review (BICR)
Complete Metabolic Response (CMR) rate [ Time Frame: Up to 5 years ]
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).

Change History

Current Secondary Outcome Measures ^ICMJE

Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment [ Time Frame: Up to 12 weeks ]
Based on blinded independent central review (BICR)
Progression Free Survival Rate (PFSR) [ Time Frame: Up to 5 years ]
Based on the blinded independent central review (BICR)
Duration of Response (DOR) [ Time Frame: Up to 5 years ]
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. [ Time Frame: Up to 5 years ]
measured by number of patients
Incidence of clinically significant abnormalities in general laboratory tests of nivolumab (BMS-936558) and brentuximab when given in combination. [ Time Frame: Up to 5 years ]
Hematology, Chemistry and Urinalysis
Incidence of clinically significant vital sign measurements of nivolumab (BMS-936558) and brentuximab when given in combination. [ Time Frame: Up to 5 years ]
Temperature, Blood Pressure and Heart Rate
Complete Metabolic Response (CMR) rate prior to HDCT/ASCT [ Time Frame: Up to 5 years ]
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 [ Time Frame: Up to 5 years ]
Low Risk Group. This is the rate prior to radiation therapy based on investigator assessments using Lugano 2014 criteria.
Event Free Survival (EFS) [ Time Frame: Up to 5 years ]
Low Risk Group. Based on investigator assessments
Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment [ Time Frame: Up to 12 weeks ]
Both Risk Groups. Based on investigator assessments
Progression Free Survival Rate (PFSR) [ Time Frame: Up to 5 years ]
Both Risk Groups. Based on investigator assessments
Duration of Response (DOR) [ Time Frame: Up to 5 years ]
Both Risk Groups. Based on investigator assessments

Original Secondary Outcome Measures ^ICMJE

Overall Response Rate (ORR) [ Time Frame: Up to 12 weeks ]
Based on blinded independent central review (BICR)
Progression Free Survival Rate (PFSR) [ Time Frame: Up to 5 years ]
Based on the blinded independent central review (BICR)
Duration of Response (DOR) [ Time Frame: Up to 5 years ]
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. [ Time Frame: Up to 5 years ]
Incidence of clinically significant abnormalities in general laboratory tests of nivolumab (BMS-936558) and brentuximab when given in combination. [ Time Frame: Up to 5 years ]
Hematology, Chemistry and Urinalysis
Incidence of clinically significant vital sign measurements of nivolumab (BMS-936558) and brentuximab when given in combination. [ Time Frame: Up to 5 years ]
Temperature, Blood Pressure and Heart Rate

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Hodgkin Disease

Intervention ^ICMJE

Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
- BMS-936558
- Opdivo
Biological: brentuximab vedotin
Specified Dose on Specified Days
Biological: bendamustine
Specified Dose on Specified Days

Study Arms ^ICMJE

Experimental: Nivolumab + brentuximab vedotin
Interventions:
- Biological: Nivolumab
- Biological: brentuximab vedotin
Experimental: brentuximab vedotin + bendamustine
Interventions:
- Biological: brentuximab vedotin
- Biological: bendamustine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

March 27, 2024

Estimated Primary Completion Date

March 27, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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 could apply

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

5 Years to 30 Years (Child, Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,	please email:	Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Listed Location Countries ^ICMJE

Canada, Czechia, France, Germany, Ireland, Italy, Netherlands, Poland, Spain, United Kingdom, United States

Removed Location Countries

Czech Republic

Administrative Information

NCT Number ^ICMJE

NCT02927769

Other Study ID Numbers ^ICMJE

CA209-744
2016-002347-41 ( EudraCT Number )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Seagen Inc.

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

PRS Account

Bristol-Myers Squibb

Verification Date

June 2020

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top