An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers

Study Overview
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Brief Summary
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The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.

Official Title
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A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors

Conditions
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Advanced Cancer

Intervention / Treatment
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* Drug: BMS-986288
* Drug: Nivolumab
* Drug: Regorafenib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy Eastern Cooperative Oncology Group Performance Status of 0 or 1 Received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies Exclusion Criteria: Active, known or suspected autoimmune disease Active malignancy requiring concurrent intervention Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: BMS-986288 Monotherapy<br> | Drug: BMS-986288<br>* Specified dose on specified days<br>|
| Experimental: Arm B: BMS-986288 in combination with Nivolumab<br> | Drug: BMS-986288<br>* Specified dose on specified days<br>Drug: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;|
| Experimental: Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib<br> | Drug: BMS-986288<br>* Specified dose on specified days<br>Drug: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;Drug: Regorafenib<br>* Specified dose on specified days<br>|

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 2 years | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 2 years | 
| Incidence of AEs meeting protocol-defined Dose Limiting Toxicities (DLT) criteria |  | Up to 2 years | 
| Incidence of AEs leading to discontinuation |  | Up to 2 years | 
| Incidence of AEs leading to death |  | Up to 2 years | 
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review | Part 2C | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Concentration (Cmax) of BMS-986288 |  | Up to 2 years | 
| Time of Maximum Observed Concentration (Tmax) of BMS-986288 |  | Up to 2 years | 
| Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288 |  | Up to 2 years | 
| Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288 |  | Up to 2 years | 
| Observed Concentration at the end of a Dosing Interval (Ctau) of BMS-986288 |  | Up to 2 years | 
| Trough Observed Concentrations (Ctrough) of BMS-986288 |  | Up to 2 years | 
| Total Body Clearance (CLT) of BMS-986288 |  | Up to 4 months | 
| Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288 |  | Up to 4 months | 
| Accumulation Index (AI) of BMS-986288 |  | Up to 4 months | 
| Terminal Half-Life (T-HALF) of BMS-986288 |  | Up to 4 months | 
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment |  | Up to 4 years | 
| Duration of Response (DOR) by RECIST v1.1 by Investigator Assessment |  | Up to 4 years | 
| Progression-Free Survival (PFS) by RECIST v1.1 by Investigator Assessment |  | Up to 4 years | 
| Time to Response (TTR) by RECIST v1.1 by Investigator Assessment |  | Up to 4 years | 
| DOR by RECIST v1.1 by blinded independent central review |  | Up to 4 years | 
| PFS by RECIST v1.1 by blinded independent central review |  | Up to 4 years | 
| Overall Survival (OS) by RECIST v1.1 by blinded independent central review |  | Up to 4 years | 
| Incidence of Adverse Events (AEs) |  | Up to 100 days following last dose of study treatment | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 100 days following last dose of study treatment | 
| Incidence of AEs meeting protocol-defined Dose Limiting Toxicities (DLT) criteria |  | Up to 100 days following last dose of study treatment | 
| Incidence of AEs leading to discontinuation |  | Up to 100 days following last dose of study treatment | 
| Incidence of AEs leading to death |  | Up to 100 days following last dose of study treatment |