A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors
- Registration Number
- NCT04943900
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1A: Monotherapy (BMS-986416) BMS-986416 - Part 1B: Combination Therapy (BMS-986416 + Nivolumab) BMS-986416 - Part 1B: Combination Therapy (BMS-986416 + Nivolumab) Nivolumab -
- Primary Outcome Measures
Name Time Method Incidence of AEs leading to discontinuation Up to 100 days after the last treatment of study intervention(s) Incidence of AEs leading to death Up to 100 days after the last treatment of study intervention(s) Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD) Up to 100 days after the last treatment of study intervention(s) Incidence of Adverse Events (AEs) Up to 100 days after the last treatment of study intervention(s) Incidence of Serious Adverse Events (SAEs) Up to 100 days after the last treatment of study intervention(s) Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria Up to 100 days after the last treatment of study intervention(s)
- Secondary Outcome Measures
Name Time Method Time of maximum observed serum concentration (Tmax) of BMS-986416 Up to 100 days after the last treatment of study intervention(s) Maximum observed serum concentration (Cmax) of BMS-986416 Up to 100 days after the last treatment of study intervention(s) Trough observed serum concentration (Ctrough) of BMS-986416 Up to 100 days after the last treatment of study intervention(s) Duration of Response (DOR) using RECIST 1.1 per Investigator assessment Up to 2 years Overall Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per Investigator assessment Up to 2 years Incidence of clinically significant changes in ECG parameters: QTcF Up to 100 days after the last treatment of study intervention(s) 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
Trial Locations
- Locations (19)
Local Institution - 0006
🇺🇸Atlanta, Georgia, United States
Local Institution - 0005
🇺🇸Baltimore, Maryland, United States
Local Institution - 0002
🇺🇸Hackensack, New Jersey, United States
Local Institution - 0013
🇺🇸Cleveland, Ohio, United States
Local Institution - 0003
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0004
🇺🇸Houston, Texas, United States
Local Institution - 0021
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0027
🇦🇷ABB, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0022
🇦🇷Caba, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0043
🇧🇪Edegem, Antwerpen, Belgium
Local Institution - 0016
🇧🇪Gent, Oost-Vlaanderen, Belgium
Local Institution - 0009
🇨🇦Edmonton, Alberta, Canada
Local Institution - 0008
🇨🇦Toronto, Ontario, Canada
Local Institution - 0001
🇨🇦Montréal, Quebec, Canada
Local Institution - 0026
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0025
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0024
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0010
🇯🇵Chuo-ku, Tokyo, Japan
Local Institution - 0020
🇳🇱Maastricht, Limburg, Netherlands