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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01968109
Other study ID # CA224-020
Secondary ID 2023-508067-70
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date November 5, 2013
Est. completion date January 31, 2025

Study information

Verified date June 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1499
Est. completion date January 31, 2025
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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) 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


Related Conditions & MeSH terms


Intervention

Biological:
Relatlimab

Nivolumab

BMS-986213
Relatlimab + Nivolumab

Locations

Country Name City State
Australia Local Institution - 0031 Brisbane Queensland
Australia Local Institution - 0033 Melbourne Victoria
Australia Local Institution - 0032 Nedlands Western Australia
Australia Local Institution - 0029 North Sydney New South Wales
Australia Local Institution - 0039 Southport Queensland
Austria Local Institution - 0023 Wien
Austria Local Institution - 0024 Wien
Canada Local Institution - 0050 Quebec City Quebec
Canada Local Institution - 0049 Toronto Ontario
Denmark Local Institution - 0028 Copenhagen
Denmark Local Institution - 0020 Herlev
Finland Local Institution - 0021 Helsinki Uusimaa
France Local Institution - 0038 Marseille Cedex 5
France Local Institution - 0037 Nantes Cedex 01
France Local Institution - 0036 Pierre Benite Cedex
France Local Institution - 0026 Toulouse Cedex 9
France Local Institution - 0018 Villejuif
Germany Local Institution - 0007 Essen
Germany Local Institution - 0040 Heilbronn
Germany Local Institution - 0041 Wuerzburg
Italy Local Institution - 0014 Milano
Italy Local Institution - 0013 Napoli
Italy Local Institution - 0035 Padova
Japan Local Institution - 0052 Chuo-ku Tokyo
Japan Local Institution - 0055 Nagoya-shi Aichi
Japan Local Institution - 0059 Sapporo-shi Hokkaido
Japan Local Institution - 0054 Sunto-gun Shizuoka
Netherlands Local Institution - 0025 Amsterdam
Norway Local Institution - 0019 Oslo
Spain Local Institution - 0015 Barcelona
Spain Local Institution - 0046 Malaga
Spain Local Institution - 0006 Pamplona
Switzerland Local Institution - 0017 Lausanne
Switzerland Local Institution - 0016 Zuerich
United Kingdom Local Institution - 0022 London Greater London
United Kingdom Local Institution - 0027 London Greater London
United Kingdom Local Institution - 0034 Manchester
United States Local Institution - 0047 Allentown Pennsylvania
United States Local Institution - 0053 Aurora Colorado
United States Local Institution - 0004 Baltimore Maryland
United States Local Institution - 0001 Boston Massachusetts
United States Local Institution - 0003 Chicago Illinois
United States Local Institution - 0057 Dallas Texas
United States Local Institution - 0011 Detroit Michigan
United States Local Institution - 0045 Houston Texas
United States Local Institution - 0043 La Jolla California
United States Local Institution - 0005 New York New York
United States Local Institution - 0048 Niles Illinois
United States Local Institution - 0010 Pittsburgh Pennsylvania
United States Local Institution - 0002 Portland Oregon
United States Local Institution - 0051 Rochester Minnesota
United States Local Institution - 0044 Saint Louis Missouri
United States Local Institution - 0008 Seattle Washington
United States Local Institution - 0058 Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Denmark,  Finland,  France,  Germany,  Italy,  Japan,  Netherlands,  Norway,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of participants with Adverse Events (AEs) Grade 3 or higher per CTCAE v4 (Common Terminology Criteria for Adverse Events) Approximately Up to 3 years
Primary Proportion of participants with Serious Adverse Events (SAEs) Grade 3 or higher per CTCAE v4 ( Common Terminology Criteria for Adverse Events) Approximately Up to 3 years
Primary Proportion of Deaths Approximately Up to 3 years
Primary Proportion of participants with laboratory abnormalities in blood Approximately Up to 3 years
Primary Proportion of participants with laboratory abnormalities in blood serum Approximately Up to 3 years
Primary Proportion of participants with laboratory abnormalities in urine Approximately Up to 3 years
Primary Objective response rate (ORR) Approximately 3 years
Primary Disease control rate (DCR) Approximately 3 years
Primary Duration of response (DOR) Approximately 3 years
Primary Number of AEs in the Broad Scope MedDRA Anaphylactic Reaction SMQ Approximately 3 years
Primary Proportion of participants with AEs leading to discontinuation of treatment Approximately up to 3 years
Secondary Maximum observed serum concentration (Cmax) of BMS-986016 administered both alone and in combination with nivolumab Approximately 2.3 years
Secondary Time of maximum observed serum concentration (Tmax) of BMS-986016 administered both alone and in combination with nivolumab Approximately 2.3 years
Secondary Trough observed serum concentration (Ctrough) of BMS-986016 administered both alone and in combination with nivolumab Approximately 2.3 years
Secondary 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 Approximately 2.3 years
Secondary Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986016 administered both alone and in combination with nivolumab Approximately 2.3 years
Secondary Total body clearance (CLT) of BMS-986016 administered both alone and in combination with nivolumab Approximately 2.3 years
Secondary Volume of distribution at steady state (Vss) of BMS-986016 administered both alone and in combination with nivolumab Approximately 2.3 years
Secondary 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 Approximately 2.3 years
Secondary 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 Approximately 2.3 years
Secondary 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 Approximately 2.3 years
Secondary 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 Approximately 2.3 years
Secondary 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 Approximately 2.3 years
Secondary Degree of fluctuation (DF) or fluctuation index ([Cmax - Ctau]/Css,avg]) of BMS-986016 administered both alone and in combination with nivolumab Approximately 2.3 years
Secondary Immunogenicity measured by anti-drug antibody (ADA) for BMS-986016 (all participants) and nivolumab Approximately 2.3 years
Secondary QTc interval from centrally read electrocardiograms (ECGs) Approximately 2.3 years
Secondary Best overall response (BOR) Approximately 3 years
Secondary ORR Approximately 3 years
Secondary DCR Approximately 3 years
Secondary Duration of response (DOR) Approximately 3 years
Secondary Progression-free survival (PFS) rates Up to approximately 3 years
Secondary Overall survival (OS) Approximately 2 years
Secondary Number of AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ Approximately 3 years
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