An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed

Study Overview
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Brief Summary
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The purpose of this study is to determine whether BMS-986299 both by itself and in combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced solid tumors. In addition, the ability of study drugs to stimulate an immune response against cancer will be investigated.

Official Title
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A Phase I Study of BMS-986299 as Monotherapy and in Combination With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers

Conditions
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Advanced Cancer

Intervention / Treatment
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* Drug: BMS-986299
* Biological: Nivolumab
* Biological: Ipilimumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed advanced/metastatic solid tumor and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant IO therapy resistant or insensitive tumors Have at least 2 tumor lesions accessible for biopsy Eastern Cooperative Oncology Group Performance Status of 0 or 1 Exclusion Criteria: Primary CNS malignancy Participants with other active malignancy requiring concurrent intervention Uncontrolled or significant cardiovascular disease 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>BMS-986299 | Drug: BMS-986299<br>* Specified dose on specified day<br>|
| Experimental: Arm B<br>BMS-986299 in combination with nivolumab and ipilimumab | Drug: BMS-986299<br>* Specified dose on specified day<br>Biological: Nivolumab<br>* Specified dose on specified day<br>* Other names: BMS-936558;Biological: Ipilimumab<br>* Specified dose on specified day<br>* Other names: BMS-734016;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose-limiting toxicities (DLTs) |  | Up to 28 days | 
| Incidence of adverse events (AEs) |  | Approximately 2 years | 
| Incidence of clinical laboratory abnormalities |  | Approximately 2 years | 
| Incidence of serious adverse events (SAEs) |  | Approximately 2 years | 
| Incidence of AEs leading to discontinuation and deaths |  | Approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Approximately 2 years | 
| Time of maximum observed plasma concentration (Tmax) |  | Approximately 2 years | 
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] |  | Approximately 2 years | 
| Area under the plasma concentration-time curve from time zero to 24 hours postdose [AUC(0-24)] |  | Approximately 2 years |