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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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/Phase 2
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
The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of
nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with
untreated advanced/metastatic hepatocellular carcinoma (HCC).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05337137
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05337137