Phase 1 Study of BMS-986416 with and without Nivolumab in Solid Tumors

JRCT ID: jRCT2031210475

Registered date:10/12/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Advanced Solid Tumors
• Date of first enrollment: 26/01/2022
• Target sample size: 134
• Countries of recruitment: US,Japan,Canada,Japan
• Study type: Interventional
• Intervention(s): Part 1A: Monotherapy (BMS-986416)/Part 1B: Combination Therapy (BMS-986416 + Nivolumab)

Outcome(s)

Primary Outcome

1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 100 days after the last treatment of study intervention(s) ]
2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 100 days after the last treatment of study intervention(s) ]
3. Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 100 days after the last treatment of study intervention(s) ]
4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 100 days after the last treatment of study intervention(s) ]
5. Incidence of AEs leading to death [ Time Frame: Up to 100 days after the last treatment of study intervention(s) ]
6. Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD) [ Time Frame: Up to 100 days after the last treatment of study intervention(s) ]

Secondary Outcome

1. Maximum observed serum concentration (Cmax) of BMS-986416 [ Time Frame: Up to 100 days after the last treatment of study intervention(s) ]
2. Time of maximum observed serum concentration (Tmax) of BMS-986416 [ Time Frame: Up to 100 days after the last treatment of study intervention(s) ]
3. Trough observed serum concentration (Ctrough) of BMS-986416 [ Time Frame: Up to 100 days after the last treatment of study intervention(s) ]
4. Overall Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per Investigator assessment [ Time Frame: Up to 2 years ]
5. Duration of Response (DOR) using RECIST 1.1 per Investigator assessment [ Time Frame: Up to 2 years ]
6. Incidence of clinically significant changes in ECG parameters: QTcF [ Time Frame: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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).

Related Information

• Primary Sponsor: Perez Raymond
• Secondary ID(s): NCT04943900