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/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
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/NCT03459222