Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04567615




Registration number
NCT04567615
Ethics application status
Date submitted
24/09/2020
Date registered
28/09/2020
Date last updated
15/03/2024

Titles & IDs
Public title
A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors
Scientific title
A Phase 2, Randomized, Open-label Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Hepatocellular Carcinoma Who Are Naive to IO Therapy But Progressed on Tyrosine Kinase Inhibitors (RELATIVITY-073)
Secondary ID [1] 0 0
2018-003151-38
Secondary ID [2] 0 0
CA224-073
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma 0 0
Hepatoma 0 0
Liver Cancer, Adult 0 0
Liver Cell Carcinoma 0 0
Liver Cell Carcinoma, Adult 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Nivolumab
Treatment: Other - Relatlimab

Experimental: Arm A : Nivolumab -

Experimental: Arm B : Nivolumab + Relatlimab Dose 1 -

Experimental: Arm C : Nivolumab + Relatlimab Dose 2 -


Treatment: Other: Nivolumab
Specified dose on specified days

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

Outcomes
Primary outcome [1] 0 0
Overall response rate (ORR) assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
Up to approximately 2.5 years
Secondary outcome [2] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to approximately 2.5 years
Secondary outcome [3] 0 0
Incidence of AEs leading to discontinuation
Timepoint [3] 0 0
Up to approximately 2.5 years
Secondary outcome [4] 0 0
Incidence of death
Timepoint [4] 0 0
Up to approximately 2.5 years
Secondary outcome [5] 0 0
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Timepoint [5] 0 0
Up to approximately 2.5 years
Secondary outcome [6] 0 0
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Timepoint [6] 0 0
Up to approximately 2.5 years
Secondary outcome [7] 0 0
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Timepoint [7] 0 0
Up to approximately 2.5 years
Secondary outcome [8] 0 0
Disease control rate (DCR) assessed by BICR per RECIST v1.1
Timepoint [8] 0 0
Up to 2 years until progression of disease
Secondary outcome [9] 0 0
Duration of response (DOR) assessed by BICR per RECIST v1.1
Timepoint [9] 0 0
Up to 2 years after first dose of treatment
Secondary outcome [10] 0 0
Progression-free survival assessed by BICR per RECIST v1.1
Timepoint [10] 0 0
Up to 2 years after first dose of treatment
Secondary outcome [11] 0 0
ORR assessed by investigator per RECIST v1.1
Timepoint [11] 0 0
Up to 2 years after first dose of treatment
Secondary outcome [12] 0 0
DCR assessed by investigator per RECIST v1.1
Timepoint [12] 0 0
Up to 2 years after first dose of treatment
Secondary outcome [13] 0 0
DOR assessed by investigator per RECIST v1.1
Timepoint [13] 0 0
Up to 2 years after first dose of treatment
Secondary outcome [14] 0 0
PFS assessed by investigator per RECIST v1.1
Timepoint [14] 0 0
Up to 2 years after first dose of treatment
Secondary outcome [15] 0 0
Overall survival (OS)
Timepoint [15] 0 0
Up to 3 years after first dose of treatment

Eligibility
Key inclusion criteria
Key

* Must have a diagnosis of hepatocellular carcinoma (HCC) based on histological confirmation
* Must have advanced/metastatic HCC
* Have to be immunotherapy treatment-naive in the advanced/metastatic setting
* Must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable untreated lesion
* Child-Pugh score of 5 or 6
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 for ECOG performance status scale

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known fibrolamellar HCC, sarcomatoid HCC, combined hepatocellular cholangiocarcinoma
* Prior organ allograft or allogeneic bone marrow transplantation
* No uncontrolled or significant cardiovascular disease
* No active known autoimmune disease
* Have received one or two lines of tyrosine kinase inhibitor therapies
* Evidence of radiographic progression on or after the last line of tyrosine kinase inhibitor therapy

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/09/2024
Actual
Sample size
Target
Accrual to date
Final
266
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Distrito Federal
Country [3] 0 0
Argentina
State/province [3] 0 0
Santa Fe
Country [4] 0 0
Argentina
State/province [4] 0 0
Tucuman
Country [5] 0 0
Brazil
State/province [5] 0 0
Minas Gerais
Country [6] 0 0
Brazil
State/province [6] 0 0
RIO Grande DO SUL
Country [7] 0 0
Brazil
State/province [7] 0 0
SAO Paulo
Country [8] 0 0
Chile
State/province [8] 0 0
Araucanía
Country [9] 0 0
Chile
State/province [9] 0 0
Metropolitana
Country [10] 0 0
China
State/province [10] 0 0
Heilongjiang
Country [11] 0 0
China
State/province [11] 0 0
Hunan
Country [12] 0 0
China
State/province [12] 0 0
Shaanxi
Country [13] 0 0
China
State/province [13] 0 0
Shan3xi
Country [14] 0 0
China
State/province [14] 0 0
Shanghai
Country [15] 0 0
China
State/province [15] 0 0
Zhejiang
Country [16] 0 0
Czechia
State/province [16] 0 0
Brno
Country [17] 0 0
Czechia
State/province [17] 0 0
Hradec Kralove
Country [18] 0 0
Czechia
State/province [18] 0 0
Prague
Country [19] 0 0
France
State/province [19] 0 0
Meurthe-et-Moselle
Country [20] 0 0
France
State/province [20] 0 0
Clichy
Country [21] 0 0
France
State/province [21] 0 0
Grenoble
Country [22] 0 0
France
State/province [22] 0 0
Lyon
Country [23] 0 0
France
State/province [23] 0 0
Pessac
Country [24] 0 0
Hong Kong
State/province [24] 0 0
Hksar
Country [25] 0 0
Hong Kong
State/province [25] 0 0
Shatin
Country [26] 0 0
Japan
State/province [26] 0 0
Ehime
Country [27] 0 0
Japan
State/province [27] 0 0
Kanagawa
Country [28] 0 0
Japan
State/province [28] 0 0
Osaka
Country [29] 0 0
Japan
State/province [29] 0 0
Ishikawa
Country [30] 0 0
Japan
State/province [30] 0 0
Kyoto
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seoul-teukbyeolsi
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Seongnam-si
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seoul
Country [34] 0 0
Mexico
State/province [34] 0 0
SAN LUIS Potosi
Country [35] 0 0
Mexico
State/province [35] 0 0
Cuauhtémoc
Country [36] 0 0
Mexico
State/province [36] 0 0
Oaxaca
Country [37] 0 0
New Zealand
State/province [37] 0 0
Auckland
Country [38] 0 0
Poland
State/province [38] 0 0
Malopolskie
Country [39] 0 0
Poland
State/province [39] 0 0
Bytom
Country [40] 0 0
Poland
State/province [40] 0 0
Mysowice
Country [41] 0 0
Poland
State/province [41] 0 0
Warszawa
Country [42] 0 0
Romania
State/province [42] 0 0
Bucure?ti
Country [43] 0 0
Romania
State/province [43] 0 0
Cluj
Country [44] 0 0
Romania
State/province [44] 0 0
Craiova
Country [45] 0 0
Romania
State/province [45] 0 0
Suceava
Country [46] 0 0
Singapore
State/province [46] 0 0
Central Singapore
Country [47] 0 0
Singapore
State/province [47] 0 0
Singapore
Country [48] 0 0
Spain
State/province [48] 0 0
Gipuzkoa
Country [49] 0 0
Spain
State/province [49] 0 0
Barcelona
Country [50] 0 0
Spain
State/province [50] 0 0
Cordoba
Country [51] 0 0
Spain
State/province [51] 0 0
Madrid
Country [52] 0 0
Spain
State/province [52] 0 0
Pamplona
Country [53] 0 0
Taiwan
State/province [53] 0 0
Taichung
Country [54] 0 0
Taiwan
State/province [54] 0 0
Tainan
Country [55] 0 0
Taiwan
State/province [55] 0 0
Taipei City
Country [56] 0 0
Taiwan
State/province [56] 0 0
Taipei
Country [57] 0 0
Taiwan
State/province [57] 0 0
Taoyuan
Country [58] 0 0
Turkey
State/province [58] 0 0
Ankara
Country [59] 0 0
Turkey
State/province [59] 0 0
Edirne
Country [60] 0 0
Turkey
State/province [60] 0 0
Kadiköy/Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04567615