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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04943900
Other study ID # CA102-003
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date August 9, 2021
Est. completion date June 4, 2028

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid tumors.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 134
Est. completion date June 4, 2028
Est. primary completion date December 15, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor - Eligible tumor types Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC), Squamous cell carcinoma of the head and neck (SCCHN), Hepatocellular carcinoma (HCC), Microsatellite-stable colorectal carcinoma (MSS CRC), or Pancreatic ductal adenocarcinoma (PDAC) - Resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit - Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) - Disease amenable to serial biopsy Exclusion Criteria: - Uncontrolled or significant cardiovascular disease - Known connective tissue disease such as Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome - Medical requirement for chronic anticoagulant or antiplatelet agents (except low-dose aspirin, which is permitted) Other protocol-defined inclusion/exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BMS-986416
Specified dose on specified days
Nivolumab
Specified dose on specified days

Locations

Country Name City State
Argentina Local Institution - 0027 ABB Ciudad Autónoma De Buenos Aires
Argentina Local Institution - 0022 Caba Ciudad Autónoma De Buenos Aires
Argentina Local Institution - 0021 Ciudad Autónoma de Buenos Aires Buenos Aires
Belgium Local Institution - 0043 Edegem Antwerpen
Belgium Local Institution - 0016 Gent Oost-Vlaanderen
Canada Local Institution - 0009 Edmonton Alberta
Canada Local Institution - 0001 Montréal Quebec
Canada Local Institution - 0008 Toronto Ontario
Chile Local Institution - 0024 Santiago Región Metropolitana De Santiago
Chile Local Institution - 0025 Santiago Región Metropolitana De Santiago
Chile Local Institution - 0026 Santiago Región Metropolitana De Santiago
Japan Local Institution - 0010 Chuo-ku Tokyo
Netherlands Local Institution - 0020 Maastricht Limburg
United States Local Institution - 0006 Atlanta Georgia
United States Local Institution - 0005 Baltimore Maryland
United States Local Institution - 0013 Cleveland Ohio
United States Local Institution - 0002 Hackensack New Jersey
United States Local Institution - 0004 Houston Texas
United States Local Institution - 0003 Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Canada,  Chile,  Japan,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events (AEs) Up to 100 days after the last treatment of study intervention(s)
Primary Incidence of Serious Adverse Events (SAEs) Up to 100 days after the last treatment of study intervention(s)
Primary Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria Up to 100 days after the last treatment of study intervention(s)
Primary Incidence of AEs leading to discontinuation Up to 100 days after the last treatment of study intervention(s)
Primary Incidence of AEs leading to death Up to 100 days after the last treatment of study intervention(s)
Primary Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD) Up to 100 days after the last treatment of study intervention(s)
Secondary Maximum observed serum concentration (Cmax) of BMS-986416 Up to 100 days after the last treatment of study intervention(s)
Secondary Time of maximum observed serum concentration (Tmax) of BMS-986416 Up to 100 days after the last treatment of study intervention(s)
Secondary Trough observed serum concentration (Ctrough) of BMS-986416 Up to 100 days after the last treatment of study intervention(s)
Secondary Overall Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per Investigator assessment Up to 2 years
Secondary Duration of Response (DOR) using RECIST 1.1 per Investigator assessment Up to 2 years
Secondary Incidence of clinically significant changes in ECG parameters: QTcF QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave Up to 100 days after the last treatment of study intervention(s)
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