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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
8/10/2024

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
Objective Response Rate(ORR) Assessed by BICR
Timepoint [1] 0 0
From randomization to primary completion date (Approximately 29.5 Months)
Secondary outcome [1] 0 0
Disease Control Rate Assessed by BICR
Timepoint [1] 0 0
From randomization to primary completion date (Approximately 29.5 Months)
Secondary outcome [2] 0 0
Duration of Response Assessed by BICR
Timepoint [2] 0 0
From randomization to primary completion date (Approximately 29.5 Months)
Secondary outcome [3] 0 0
Progression Free Survival(PFS) Assessed by BICR
Timepoint [3] 0 0
From randomization to primary completion date (Approximately 29.5 Months)
Secondary outcome [4] 0 0
Objective Response Rate Assessed by Investigator
Timepoint [4] 0 0
From randomization to primary completion date (Approximately 29.5 Months)
Secondary outcome [5] 0 0
Disease Control Rate Assessed by Investigator
Timepoint [5] 0 0
From randomization to primary completion date (Approximately 29.5 Months)
Secondary outcome [6] 0 0
Duration of Response Assessed by Investigator
Timepoint [6] 0 0
From randomization to primary completion date (Approximately 29.5 Months)
Secondary outcome [7] 0 0
Progression Free Survival(PFS) Assessed by Investigator
Timepoint [7] 0 0
From randomization to primary completion date (Approximately 29.5 Months)
Secondary outcome [8] 0 0
Overall Survival (OS)
Timepoint [8] 0 0
From randomization to primary completion date (Approximately 29.5 Months)
Secondary outcome [9] 0 0
Number of Participants With Adverse Events
Timepoint [9] 0 0
From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
Secondary outcome [10] 0 0
Number of Participants With Serious Adverse Events
Timepoint [10] 0 0
From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
Secondary outcome [11] 0 0
Number of Participants With Adverse Events Leading to Discontinuation
Timepoint [11] 0 0
From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
Secondary outcome [12] 0 0
Death Summary
Timepoint [12] 0 0
From randomization to primary completion date (Approximately 29.5 Months)
Secondary outcome [13] 0 0
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
Timepoint [13] 0 0
From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
Secondary outcome [14] 0 0
Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests
Timepoint [14] 0 0
From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.

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
5/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/12/2024
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
Chile
State/province [10] 0 0
Región Metropolitana De Santiago
Country [11] 0 0
China
State/province [11] 0 0
Heilongjiang
Country [12] 0 0
China
State/province [12] 0 0
Hunan
Country [13] 0 0
China
State/province [13] 0 0
Shaanxi
Country [14] 0 0
China
State/province [14] 0 0
Shan3xi
Country [15] 0 0
China
State/province [15] 0 0
Shanghai
Country [16] 0 0
China
State/province [16] 0 0
Zhejiang
Country [17] 0 0
Czechia
State/province [17] 0 0
Brno
Country [18] 0 0
Czechia
State/province [18] 0 0
Hradec Kralove
Country [19] 0 0
Czechia
State/province [19] 0 0
Prague
Country [20] 0 0
France
State/province [20] 0 0
Meurthe-et-Moselle
Country [21] 0 0
France
State/province [21] 0 0
Clichy
Country [22] 0 0
France
State/province [22] 0 0
Grenoble
Country [23] 0 0
France
State/province [23] 0 0
Lyon
Country [24] 0 0
France
State/province [24] 0 0
Pessac
Country [25] 0 0
Hong Kong
State/province [25] 0 0
Hksar
Country [26] 0 0
Hong Kong
State/province [26] 0 0
Shatin
Country [27] 0 0
Japan
State/province [27] 0 0
Ehime
Country [28] 0 0
Japan
State/province [28] 0 0
Kanagawa
Country [29] 0 0
Japan
State/province [29] 0 0
Osaka
Country [30] 0 0
Japan
State/province [30] 0 0
Ishikawa
Country [31] 0 0
Japan
State/province [31] 0 0
Kyoto
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Seoul-teukbyeolsi
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seongnam-si
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Seoul
Country [35] 0 0
Mexico
State/province [35] 0 0
SAN LUIS Potosi
Country [36] 0 0
Mexico
State/province [36] 0 0
Cuauhtémoc
Country [37] 0 0
Mexico
State/province [37] 0 0
Oaxaca
Country [38] 0 0
New Zealand
State/province [38] 0 0
Auckland
Country [39] 0 0
Poland
State/province [39] 0 0
Malopolskie
Country [40] 0 0
Poland
State/province [40] 0 0
Bytom
Country [41] 0 0
Poland
State/province [41] 0 0
Mysowice
Country [42] 0 0
Poland
State/province [42] 0 0
Warszawa
Country [43] 0 0
Romania
State/province [43] 0 0
Dolj
Country [44] 0 0
Romania
State/province [44] 0 0
Bucure?ti
Country [45] 0 0
Romania
State/province [45] 0 0
Cluj
Country [46] 0 0
Romania
State/province [46] 0 0
Suceava
Country [47] 0 0
Singapore
State/province [47] 0 0
Central Singapore
Country [48] 0 0
Singapore
State/province [48] 0 0
Singapore
Country [49] 0 0
Spain
State/province [49] 0 0
Gipuzkoa
Country [50] 0 0
Spain
State/province [50] 0 0
Barcelona
Country [51] 0 0
Spain
State/province [51] 0 0
Cordoba
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid
Country [53] 0 0
Spain
State/province [53] 0 0
Pamplona
Country [54] 0 0
Taiwan
State/province [54] 0 0
Taichung
Country [55] 0 0
Taiwan
State/province [55] 0 0
Tainan
Country [56] 0 0
Taiwan
State/province [56] 0 0
Taipei City
Country [57] 0 0
Taiwan
State/province [57] 0 0
Taipei
Country [58] 0 0
Taiwan
State/province [58] 0 0
Taoyuan
Country [59] 0 0
Turkey
State/province [59] 0 0
Ankara
Country [60] 0 0
Turkey
State/province [60] 0 0
Edirne
Country [61] 0 0
Turkey
State/province [61] 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
The purpose of this study is to evaluate the effectiveness and safety 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 inhibitor therapy.
Trial website
https://clinicaltrials.gov/study/NCT04567615
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04567615