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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03138499




Registration number
NCT03138499
Ethics application status
Date submitted
1/05/2017
Date registered
3/05/2017
Date last updated
29/04/2019

Titles & IDs
Public title
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,
Scientific 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)
Secondary ID [1] 0 0
2017-000847-41
Secondary ID [2] 0 0
CA209-812
Universal Trial Number (UTN)
Trial acronym
CheckMate 812
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hodgkin's Disease 0 0
Condition category
Condition code
Cancer 0 0 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Nivolumab
Other interventions - Brentuximab vedotin

Experimental: Module A - Nivolumab combined with Brentuximab

Experimental: Module B - Brentuximab alone


Other interventions: Nivolumab
Specified dose on specified days

Other interventions: Brentuximab vedotin
Specified dose on specified days

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) - To compare progression free survival of nivolumab + Brentuximab vedotin (BV) versus BV based on Blinded Independent Central Review (BICR) assessments
Timepoint [1] 0 0
Up to four years
Secondary outcome [1] 0 0
Complete Response Rate (CRR) - To compare the complete response rate of nivolumab + BV versus BV based on BICR assessments
Timepoint [1] 0 0
Up to four years
Secondary outcome [2] 0 0
Objective Response Rate (ORR) - To assess objective response rate and duration of response based on BICR
Timepoint [2] 0 0
Up to four years
Secondary outcome [3] 0 0
Duration of response (DOR) - To assess duration of response based on BICR
Timepoint [3] 0 0
Up to four years
Secondary outcome [4] 0 0
Duration of complete response (DOCR) - To assess duration of complete response based on BICR
Timepoint [4] 0 0
Up to four years
Secondary outcome [5] 0 0
Overall Survival (OS) - To assess overall survival of participants treated with nivolumab + BV versus BV
Timepoint [5] 0 0
Up to four years
Secondary outcome [6] 0 0
Progression Free Survival (PFS) - To assess PFS based on investigator assessments
Timepoint [6] 0 0
Up to four years

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



- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 could apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - Albury
Recruitment hospital [2] 0 0
Local Institution - Randwick
Recruitment hospital [3] 0 0
Local Institution - Brisbane
Recruitment hospital [4] 0 0
Local Institution - Woolloongabba
Recruitment hospital [5] 0 0
Local Institution - Heidelberg
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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District of Columbia
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Florida
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United States of America
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Indiana
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United States of America
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Kansas
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United States of America
State/province [9] 0 0
Kentucky
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United States of America
State/province [10] 0 0
Louisiana
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Massachusetts
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Michigan
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Minnesota
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Missouri
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New Jersey
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New York
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North Carolina
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Pennsylvania
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South Carolina
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United States of America
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Tennessee
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Texas
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United States of America
State/province [22] 0 0
Virginia
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United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
Czechia
State/province [24] 0 0
Prague 2
Country [25] 0 0
Hungary
State/province [25] 0 0
Debrecen
Country [26] 0 0
Italy
State/province [26] 0 0
Milano
Country [27] 0 0
Italy
State/province [27] 0 0
Reggio Emilia
Country [28] 0 0
Japan
State/province [28] 0 0
Aichi
Country [29] 0 0
Japan
State/province [29] 0 0
Fukuoka
Country [30] 0 0
Japan
State/province [30] 0 0
Kanagawa
Country [31] 0 0
Japan
State/province [31] 0 0
Miyagi
Country [32] 0 0
Japan
State/province [32] 0 0
Osaka
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Japan
State/province [33] 0 0
Tokyo
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Puerto Rico
State/province [34] 0 0
San Juan
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Turkey
State/province [35] 0 0
Ankara
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Turkey
State/province [36] 0 0
Samsun

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Seattle Genetics, Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Ono Pharmaceutical Co. Ltd
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT03138499
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Address 0 0
Country 0 0
Phone 0 0
please email:
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03138499