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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03459222




Registration number
NCT03459222
Ethics application status
Date submitted
2/03/2018
Date registered
8/03/2018
Date last updated
20/08/2024

Titles & IDs
Public title
An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread
Scientific title
A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) Administered in Combination With Both Nivolumab (Anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 Inhibitor) or in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors
Secondary ID [1] 0 0
2018-000058-22
Secondary ID [2] 0 0
CA224-048
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Relatlimab
Treatment: Other - Nivolumab
Treatment: Drugs - BMS-986205
Treatment: Other - Ipilimumab

Experimental: Arm A - Relatlimab + Nivolumab + BMS-986205

Experimental: Arm B - Relatlimab + Nivolumab + Ipilimumab


Treatment: Other: Relatlimab
Specified dose on specified days

Treatment: Other: Nivolumab
Specified dose on specified days

Treatment: Drugs: BMS-986205
Specified dose on specified days

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

Outcomes
Primary outcome [1] 0 0
Number of clinical laboratory test abnormalities
Timepoint [1] 0 0
Approximately 4 years
Primary outcome [2] 0 0
Number of Adverse Events (AEs)
Timepoint [2] 0 0
Approximately 4 years
Primary outcome [3] 0 0
Number of Serious Adverse Events (SAEs)
Timepoint [3] 0 0
Approximately 4 years
Primary outcome [4] 0 0
Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Timepoint [4] 0 0
Up to 6 weeks
Primary outcome [5] 0 0
Number of AEs leading to discontinuation
Timepoint [5] 0 0
Approximately 4 years
Primary outcome [6] 0 0
Number of AEs leading to death
Timepoint [6] 0 0
Approximately 4 years
Primary outcome [7] 0 0
Objective Response Rate (ORR)
Timepoint [7] 0 0
Approximately 4 years
Primary outcome [8] 0 0
Disease Control Rate (DCR)
Timepoint [8] 0 0
Approximately 4 years
Primary outcome [9] 0 0
Median Duration of Response (mDOR)
Timepoint [9] 0 0
Approximately 4 years
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Up to 4 years

Eligibility
Key inclusion criteria
* Histologic or cytologic confirmation of select incurable solid malignancies that are advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1
* Available tumor tissue for biomarker analysis
* Eastern Cooperative Oncology Group Performance Status (ECOG) status of 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 or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease
* History of interstitial lung disease / pneumonitis
* Prior malignancy active within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer
* Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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 1
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
30/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/11/2026
Actual
Sample size
Target
255
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Local Institution - 0012 - Wollstonecraft
Recruitment hospital [2] 0 0
Local Institution - 0011 - Nedlands
Recruitment postcode(s) [1] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [2] 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
Colorado
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
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
France
State/province [6] 0 0
Marseille Cedex 5
Country [7] 0 0
France
State/province [7] 0 0
Toulouse Cedex 9
Country [8] 0 0
France
State/province [8] 0 0
Villejuif
Country [9] 0 0
Italy
State/province [9] 0 0
Forlì
Country [10] 0 0
Italy
State/province [10] 0 0
Napoli
Country [11] 0 0
Italy
State/province [11] 0 0
Rome
Country [12] 0 0
Spain
State/province [12] 0 0
Barcelona
Country [13] 0 0
Spain
State/province [13] 0 0
Madrid
Country [14] 0 0
Spain
State/province [14] 0 0
Málaga
Country [15] 0 0
Spain
State/province [15] 0 0
Pamplona
Country [16] 0 0
Switzerland
State/province [16] 0 0
Lausanne
Country [17] 0 0
Switzerland
State/province [17] 0 0
Zuerich
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Headington
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Newcastle Upon Tyne

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 demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab in immunotherapy-naive and pretreated populations across select advanced tumor types.
Trial website
https://clinicaltrials.gov/study/NCT03459222
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/NCT03459222