A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase 1 Study of BMS-986416 Alone and in Combination With Nivolumab in Select Solid Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04943900
• Other study ID #: CA102-003
• Status: Active, not recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

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)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting