An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread

Study Overview
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Brief Summary
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The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.

Official Title
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A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors

Conditions
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Advanced Cancer

Intervention / Treatment
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* Biological: BMS-986258
* Biological: Nivolumab
* Drug: rHuPH20


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic confirmation of one of the 5 tumors [renal cell carcinoma (RCC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC)] (metastatic, recurrent, and/or unresectable), with measurable disease per response evaluation criteria in solid tumors v1.1 (RECIST v1.1) Eastern Cooperative Oncology Group Performance Status of 0 or 1 Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies Women must agree to follow specific methods of contraception, if applicable Exclusion Criteria: Active, known or suspected autoimmune disease Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy Other active malignancy requiring concurrent intervention 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: Part A Dose Escalation: BMS-986258<br> | Biological: BMS-986258<br>* Specified dose on specified days<br>|
| Experimental: Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)<br> | Biological: BMS-986258<br>* Specified dose on specified days<br>Drug: rHuPH20<br>* Specified dose on specified days<br>* Other names: Enhanze;|
| Experimental: Part B Dose Escalation: BMS-986258 + nivolumab<br> | Biological: BMS-986258<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;|
| Experimental: Part C Cohort Expansion: BMS-986258 + nivolumab<br> | Biological: BMS-986258<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | Approximately 2 years | 
| Incidence of serious adverse events (SAEs) |  | Approximately 2 years | 
| Incidence of AEs leading to discontinuation |  | Approximately 2 years | 
| Incidence of AEs leading to death |  | Approximately 2 years | 
| Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria |  | Approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) |  | Up to 12 months | 
| Median duration of response (mDOR) |  | Up to 12 months | 
| Progression free survival (PFS) rate |  | Up to 12 months | 
| Maximum observed serum concentration (Cmax) |  | Approximately 2 years | 
| Time of maximum observed 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 | 
| Observed concentration at the end of a dosing interval (Ctau) |  | Approximately 2 years | 
| Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] |  | Approximately 2 years | 
| Trough observed serum concentration at the end of the dosing interval (Ctrough) |  | Approximately 2 years | 
| Concentration at the end of infusion (Ceoi) |  | Approximately 2 years | 
| Incidence of anti-drug antibody (ADA) to BMS-986258 |  | Approximately 2 years |