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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01968109




Registration number
NCT01968109
Ethics application status
Date submitted
25/09/2013
Date registered
23/10/2013
Date last updated
17/07/2024

Titles & IDs
Public title
An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors
Scientific title
A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
Secondary ID [1] 0 0
2023-508067-70
Secondary ID [2] 0 0
CA224-020
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms by Site 0 0
Condition category
Condition code
Cancer 0 0 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - BMS-986213

Experimental: Relatlimab - Relatlimab (BMS-986016) specified dose on specified days

Experimental: Relatlimab + Nivolumab - Relatlimab (BMS-986016) + Nivolumab (BMS-936558) specified dose on specified days

Experimental: BMS-986213 - Relatlimab (BMS-986016) + Nivolumab (BMS-936558)


Treatment: Other: BMS-986213
Relatlimab + Nivolumab
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with Adverse Events (AEs)
Timepoint [1] 0 0
Approximately Up to 3 years
Primary outcome [2] 0 0
Proportion of participants with Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Approximately Up to 3 years
Primary outcome [3] 0 0
Proportion of Deaths
Timepoint [3] 0 0
Approximately Up to 3 years
Primary outcome [4] 0 0
Proportion of participants with laboratory abnormalities in blood
Timepoint [4] 0 0
Approximately Up to 3 years
Primary outcome [5] 0 0
Proportion of participants with laboratory abnormalities in blood serum
Timepoint [5] 0 0
Approximately Up to 3 years
Primary outcome [6] 0 0
Proportion of participants with laboratory abnormalities in urine
Timepoint [6] 0 0
Approximately Up to 3 years
Primary outcome [7] 0 0
Objective response rate (ORR)
Timepoint [7] 0 0
Approximately 3 years
Primary outcome [8] 0 0
Disease control rate (DCR)
Timepoint [8] 0 0
Approximately 3 years
Primary outcome [9] 0 0
Duration of response (DOR)
Timepoint [9] 0 0
Approximately 3 years
Primary outcome [10] 0 0
Number of AEs in the Broad Scope MedDRA Anaphylactic Reaction SMQ
Timepoint [10] 0 0
Approximately 3 years
Primary outcome [11] 0 0
Proportion of participants with AEs leading to discontinuation of treatment
Timepoint [11] 0 0
Approximately up to 3 years
Secondary outcome [1] 0 0
Maximum observed serum concentration (Cmax) of BMS-986016 administered both alone and in combination with nivolumab
Timepoint [1] 0 0
Approximately 2.3 years
Secondary outcome [2] 0 0
Time of maximum observed serum concentration (Tmax) of BMS-986016 administered both alone and in combination with nivolumab
Timepoint [2] 0 0
Approximately 2.3 years
Secondary outcome [3] 0 0
Trough observed serum concentration (Ctrough) of BMS-986016 administered both alone and in combination with nivolumab
Timepoint [3] 0 0
Approximately 2.3 years
Secondary outcome [4] 0 0
Concentration at the end of a dosing interval (Ctau) [Eg: concentration at 336 hours] of BMS-986016 administered both alone and in combination with nivolumab
Timepoint [4] 0 0
Approximately 2.3 years
Secondary outcome [5] 0 0
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986016 administered both alone and in combination with nivolumab
Timepoint [5] 0 0
Approximately 2.3 years
Secondary outcome [6] 0 0
Total body clearance (CLT) of BMS-986016 administered both alone and in combination with nivolumab
Timepoint [6] 0 0
Approximately 2.3 years
Secondary outcome [7] 0 0
Volume of distribution at steady state (Vss) of BMS-986016 administered both alone and in combination with nivolumab
Timepoint [7] 0 0
Approximately 2.3 years
Secondary outcome [8] 0 0
Effective elimination half-life that explains the degree of area under the concentration-time curve (AUC) accumulation observed (T-HALFeff AUC) of BMS-986016 administered both alone and in combination with nivolumab
Timepoint [8] 0 0
Approximately 2.3 years
Secondary outcome [9] 0 0
Effective elimination half-life that explains the degree of Cmax accumulation observed (T-HALFeff Cmax) of BMS-986016 administered both alone and in combination with nivolumab
Timepoint [9] 0 0
Approximately 2.3 years
Secondary outcome [10] 0 0
Accumulation index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986016 administered both alone and in combination with nivolumab
Timepoint [10] 0 0
Approximately 2.3 years
Secondary outcome [11] 0 0
Cmax accumulation index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) of BMS-986016 administered both alone and in combination with nivolumab
Timepoint [11] 0 0
Approximately 2.3 years
Secondary outcome [12] 0 0
Ctau accumulation index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) of BMS-986016 administered both alone and in combination with nivolumab
Timepoint [12] 0 0
Approximately 2.3 years
Secondary outcome [13] 0 0
Degree of fluctuation (DF) or fluctuation index ([Cmax - Ctau]/Css,avg]) of BMS-986016 administered both alone and in combination with nivolumab
Timepoint [13] 0 0
Approximately 2.3 years
Secondary outcome [14] 0 0
Immunogenicity measured by anti-drug antibody (ADA) for BMS-986016 (all participants) and nivolumab
Timepoint [14] 0 0
Approximately 2.3 years
Secondary outcome [15] 0 0
QTc interval from centrally read electrocardiograms (ECGs)
Timepoint [15] 0 0
Approximately 2.3 years
Secondary outcome [16] 0 0
Best overall response (BOR)
Timepoint [16] 0 0
Approximately 3 years
Secondary outcome [17] 0 0
ORR
Timepoint [17] 0 0
Approximately 3 years
Secondary outcome [18] 0 0
DCR
Timepoint [18] 0 0
Approximately 3 years
Secondary outcome [19] 0 0
Duration of response (DOR)
Timepoint [19] 0 0
Approximately 3 years
Secondary outcome [20] 0 0
Progression-free survival (PFS) rates
Timepoint [20] 0 0
Up to approximately 3 years
Secondary outcome [21] 0 0
Overall survival (OS)
Timepoint [21] 0 0
Approximately 2 years
Secondary outcome [22] 0 0
Number of AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ
Timepoint [22] 0 0
Approximately 3 years

Eligibility
Key inclusion criteria
* For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer (CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4.
* For Dose Expansion: all of the above in escalation except for cervical, ovarian, and CRC
* Progressed, or been intolerant to, at least one standard treatment regimen, except for participants in 1st line cohorts.
* ECOG performance status between 0 and 2
* At least 1 lesion with measurable disease at baseline
* Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease
* Autoimmune disease
* Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
* Uncontrolled CNS metastases

Other protocol defined inclusion/exclusion criteria could 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 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
5/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
Accrual to date
Final
1499
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0029 - North Sydney
Recruitment hospital [2] 0 0
Local Institution - 0031 - Brisbane
Recruitment hospital [3] 0 0
Local Institution - 0039 - Southport
Recruitment hospital [4] 0 0
Local Institution - 0033 - Melbourne
Recruitment hospital [5] 0 0
Local Institution - 0032 - Nedlands
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
4120 - Brisbane
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
3000 - 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
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Austria
State/province [15] 0 0
Wien
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Denmark
State/province [18] 0 0
Copenhagen
Country [19] 0 0
Denmark
State/province [19] 0 0
Herlev
Country [20] 0 0
Finland
State/province [20] 0 0
Uusimaa
Country [21] 0 0
France
State/province [21] 0 0
Marseille Cedex 5
Country [22] 0 0
France
State/province [22] 0 0
Nantes Cedex 01
Country [23] 0 0
France
State/province [23] 0 0
Pierre Benite Cedex
Country [24] 0 0
France
State/province [24] 0 0
Toulouse Cedex 9
Country [25] 0 0
France
State/province [25] 0 0
Villejuif
Country [26] 0 0
Germany
State/province [26] 0 0
Essen
Country [27] 0 0
Germany
State/province [27] 0 0
Heilbronn
Country [28] 0 0
Germany
State/province [28] 0 0
Wuerzburg
Country [29] 0 0
Italy
State/province [29] 0 0
Milano
Country [30] 0 0
Italy
State/province [30] 0 0
Napoli
Country [31] 0 0
Italy
State/province [31] 0 0
Padova
Country [32] 0 0
Japan
State/province [32] 0 0
Aichi
Country [33] 0 0
Japan
State/province [33] 0 0
Hokkaido
Country [34] 0 0
Japan
State/province [34] 0 0
Shizuoka
Country [35] 0 0
Japan
State/province [35] 0 0
Tokyo
Country [36] 0 0
Netherlands
State/province [36] 0 0
Amsterdam
Country [37] 0 0
Norway
State/province [37] 0 0
Oslo
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Malaga
Country [40] 0 0
Spain
State/province [40] 0 0
Pamplona
Country [41] 0 0
Switzerland
State/province [41] 0 0
Lausanne
Country [42] 0 0
Switzerland
State/province [42] 0 0
Zuerich
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Greater London
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Manchester

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/NCT01968109