A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1A: Monotherapy (BMS-986416)
|
Drug: BMS-986416
Specified dose on specified days
|
| Experimental: Part 1B: Combination Therapy (BMS-986416 + Nivolumab)
|
Drug: BMS-986416
Specified dose on specified days
Drug: Nivolumab
Specified dose on specified days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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)]
- Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD) [Up to 100 days after the last treatment of study intervention(s)]
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Atlanta | Georgia | United States | 30322 |
| 2 | Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics | Baltimore | Maryland | United States | 21287 |
| 3 | John Theurer Cancer Center | Hackensack | New Jersey | United States | 07601 |
| 4 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106-5055 |
| 5 | UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | United States | 15232 |
| 6 | University of Texas MD Anderson Cancer Center-Investigational Cancer Therapeutics | Houston | Texas | United States | 77030 |
| 7 | Local Institution | Toronto | Ontario | Canada | M5G 1Z5 |
| 8 | Local Institution - 0001 | Montréal | Quebec | Canada | H2X 3H8 |
| 9 | Local Institution | Edmonton | Canada | T6G 1Z2 | |
| 10 | Local Institution - 0010 | Chuo-ku | Tokyo | Japan | 104-0045 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CA102-003