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

Study Overview
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Brief Summary
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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.

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

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: BMS-986416
* Drug: Nivolumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1A: Monotherapy (BMS-986416)<br> | Drug: BMS-986416<br>* Specified dose on specified days<br>|
| Experimental: Part 1B: Combination Therapy (BMS-986416 + Nivolumab)<br> | Drug: BMS-986416<br>* Specified dose on specified days<br>Drug: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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)