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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05337137




Registration number
NCT05337137
Ethics application status
Date submitted
13/04/2022
Date registered
20/04/2022
Date last updated
10/05/2024

Titles & IDs
Public title
A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer
Scientific title
A Phase 1/2, Safety Confirmation, Placebo-controlled, Randomized Study of Nivolumab in Combination With Relatlimab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma
Secondary ID [1] 0 0
2021-003606-53
Secondary ID [2] 0 0
CA224-106
Universal Trial Number (UTN)
Trial acronym
RELATIVITY-106
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Hepatocellular 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

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Relatlimab
Treatment: Drugs - Nivolumab
Treatment: Drugs - Bevacizumab
Other interventions - Placebo

Experimental: Arm A: Relatlimab + Nivolumab + Bevacizumab -

Experimental: Arm B: Placebo + Nivolumab + Bevacizumab -


Treatment: Drugs: Relatlimab
Specified dose on specified days

Treatment: Drugs: Nivolumab
Specified dose on specified days

Treatment: Drugs: Bevacizumab
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose-limiting toxicities (DLTs)
Timepoint [1] 0 0
Up to 6 weeks
Primary outcome [2] 0 0
Overall Response Rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [2] 0 0
Assessed up to 3 years
Secondary outcome [1] 0 0
Progression Free Survival (PFS) by BICR per RECIST v1.1 in all randomized participants that are lymphocyte activation gene 3 (LAG-3) positive
Timepoint [1] 0 0
Assessed up to 3 years
Secondary outcome [2] 0 0
PFS by BICR per RECIST v1.1 in all randomized participants
Timepoint [2] 0 0
Assessed up to 3 years
Secondary outcome [3] 0 0
ORR by BICR per RECIST v1.1 in all randomized participants that are LAG-3 positive
Timepoint [3] 0 0
Assessed up to 3 years
Secondary outcome [4] 0 0
Overall Survival (OS) of all randomized participants
Timepoint [4] 0 0
Assessed up to 3 years
Secondary outcome [5] 0 0
OS of all randomized participants that are LAG-3 positive
Timepoint [5] 0 0
Assessed up to 3 years
Secondary outcome [6] 0 0
Number of participants with adverse events (AEs)
Timepoint [6] 0 0
Up to 135 days after participant's last dose

Eligibility
Key inclusion criteria
* Histologically confirmed advanced/metastatic hepatocellular carcinoma (HCC)
* Naïve to systemic therapy for advanced/metastatic HCC (prior neo-adjuvant or adjuvant immunotherapy is permitted if recurrence occurs = 6 months after treatment completion and the case is discussed with BMS medical team)
* Child-Pugh score of 5 or 6 (ie, Child-Pugh A)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
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 or mixed cholangiocarcinoma and HCC
* Prior allogenic stem cell or solid organ transplantation
* Untreated symptomatic central nervous system (CNS) metastases
* Clinically significant ascites as defined by:

i) Prior ascites that required treatment and requires on-going prophylaxis, or ii) Current ascites requiring treatment

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
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
5/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/12/2026
Actual
Sample size
Target
162
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0045 - Camperdown
Recruitment hospital [2] 0 0
Local Institution - 0022 - Adelaide
Recruitment hospital [3] 0 0
Olivia Newton-John Cancer Research Institute - Heidelberg
Recruitment hospital [4] 0 0
St. Vincents Hospital - Melbourne
Recruitment hospital [5] 0 0
Local Institution - 0017 - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3065 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
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
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Wisconsin
Country [7] 0 0
Canada
State/province [7] 0 0
Alberta
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
China
State/province [9] 0 0
Guangdong
Country [10] 0 0
China
State/province [10] 0 0
Shan3xi
Country [11] 0 0
France
State/province [11] 0 0
Cedex 9
Country [12] 0 0
France
State/province [12] 0 0
Bondy
Country [13] 0 0
France
State/province [13] 0 0
Grenoble
Country [14] 0 0
France
State/province [14] 0 0
Nice
Country [15] 0 0
France
State/province [15] 0 0
Reims
Country [16] 0 0
France
State/province [16] 0 0
Rennes
Country [17] 0 0
France
State/province [17] 0 0
Suresnes
Country [18] 0 0
Germany
State/province [18] 0 0
North Rhine-Westphalia
Country [19] 0 0
Germany
State/province [19] 0 0
Frankfurt
Country [20] 0 0
Germany
State/province [20] 0 0
Mainz
Country [21] 0 0
Germany
State/province [21] 0 0
Munich
Country [22] 0 0
Hong Kong
State/province [22] 0 0
Hong Kong
Country [23] 0 0
Hong Kong
State/province [23] 0 0
Shatin
Country [24] 0 0
Italy
State/province [24] 0 0
Milano
Country [25] 0 0
Italy
State/province [25] 0 0
MI
Country [26] 0 0
Italy
State/province [26] 0 0
Padova
Country [27] 0 0
Italy
State/province [27] 0 0
Roma
Country [28] 0 0
Japan
State/province [28] 0 0
Chiba
Country [29] 0 0
Japan
State/province [29] 0 0
Ehime
Country [30] 0 0
Japan
State/province [30] 0 0
Ishikawa
Country [31] 0 0
Japan
State/province [31] 0 0
Kanagawa
Country [32] 0 0
Japan
State/province [32] 0 0
Osaka
Country [33] 0 0
Japan
State/province [33] 0 0
Tokyo
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Gyeonggido
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Seoul
Country [36] 0 0
Poland
State/province [36] 0 0
Kujawsko-pomorskie
Country [37] 0 0
Poland
State/province [37] 0 0
Mazowieckie
Country [38] 0 0
Poland
State/province [38] 0 0
Pomorskie
Country [39] 0 0
Puerto Rico
State/province [39] 0 0
Rio Piedras
Country [40] 0 0
Puerto Rico
State/province [40] 0 0
San Juan
Country [41] 0 0
Singapore
State/province [41] 0 0
Singapore
Country [42] 0 0
Spain
State/province [42] 0 0
A Coruña
Country [43] 0 0
Spain
State/province [43] 0 0
Cantabria
Country [44] 0 0
Spain
State/province [44] 0 0
Sede Madrid
Country [45] 0 0
Spain
State/province [45] 0 0
Madrid
Country [46] 0 0
Spain
State/province [46] 0 0
Pamplona
Country [47] 0 0
Spain
State/province [47] 0 0
Zaragoza
Country [48] 0 0
Taiwan
State/province [48] 0 0
Tai Zhong Shi
Country [49] 0 0
Taiwan
State/province [49] 0 0
Taichung
Country [50] 0 0
Taiwan
State/province [50] 0 0
Taipei

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
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
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/NCT05337137