Advanced Solid Tumors
Conditions
Keywords
BMS-986416, Nivolumab, Opdivo, 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), Pancreatic ductal adenocarcinoma (PDAC)
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.
Interventions
DRUGBMS-986416
Specified dose on specified days
DRUGNivolumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed serum concentration (Cmax) of BMS-986416 | Up to 100 days after the last treatment of study intervention(s) | — |
| Time of maximum observed serum concentration (Tmax) 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) | — |
| Overall Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per Investigator assessment | Up to 2 years | — |
| Duration of Response (DOR) using 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 |
Countries
Argentina, Belgium, Canada, Chile, Japan, Netherlands, United States
Outcome results
None listed