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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03138499
Ethics application status
Date submitted
1/05/2017
Date registered
3/05/2017
Date last updated
10/01/2024

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
Treatment: Other - Nivolumab
Treatment: Other - Brentuximab vedotin

Experimental: Module A - Nivolumab combined with Brentuximab

Experimental: Module B - Brentuximab alone


Treatment: Other: Nivolumab
Specified dose on specified days

Treatment: Other: Brentuximab vedotin
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
From randomization to date of death, or disease progression (up to approximately 45 months)
Secondary outcome [1] 0 0
Complete Response Rate (CRR):
Timepoint [1] 0 0
From randomization up to approximately 45 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
From randomization up to approximately 45 months
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
From randomization to date of documented progression or death (up to approximately 45 months)
Secondary outcome [4] 0 0
Duration of Complete Response (DOCR)
Timepoint [4] 0 0
From randomization to date of documented progression or death (up to approximately 45 months)
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
From randomization to the date of death (up to approximately 3 years 7 months)

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/02/2021
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Japan
State/province [14] 0 0
Miyagi
Country [15] 0 0
Puerto Rico
State/province [15] 0 0
San Juan

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
Seagen 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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03138499