A Study of BMS-986205 Given in Combination With Nivolumab in Patients With Advanced Tumors

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and tolerability for the combination therapy of BMS-986205 and Nivolumab in patients with advanced tumors

Official Title
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A Phase 1 Study for Safety and Tolerability of BMS-986205 Administered in Combination With Nivolumab (BMS-936558) in Advanced Malignant Tumors

Conditions
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Advanced Cancer

Intervention / Treatment
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* Drug: BMS-986205
* Biological: Nivolumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Participants must have histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) Participants must have received, and then progressed or been intolerant to standard treatment regimen in the advanced or metastatic setting Eastern Cooperative Oncology Group performance status of ≤ 1 Exclusion Criteria: Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded History of congenital or autoimmune hemolytic disorders History or presence of hypersensitivity or idiosyncratic reaction to methylene blue Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Escalation<br>monotherapy and combination therapy | Drug: BMS-986205<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified day<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) | Safety and Tolerability | 15 months | 
| Incidence of Serious Adverse Events (SAEs) | Safety and Tolerability | 15 months | 
| Incidence of Death | Safety and Tolerability | 15 months | 
| Incidence of Laboratory Abnormalities | Safety and Tolerability | 15 months | 
| AEs leading to discontinuation | Safety and Tolerability | Up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) | To characterize the Pharmacokinetics (PK) of BMS-986205 administered alone and in combination with nivolumab | Up to one year | 
| Time of maximum observed plasma concentration (Tmax) | To characterize the PK of BMS-986205 administered alone and in combination with nivolumab | Up to one year | 
| Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] | To characterize the PK of BMS-986205 administered alone and in combination with nivolumab | Up to one year | 
| Trough observed plasma concentration at the end of the dosing interval (Ctrough) | To characterize the PK of BMS-986205 administered alone and in combination with nivolumab | Up to one year | 
| Apparent total body clearance (CLT/F) | To characterize the PK of BMS-986205 administered alone and in combination with nivolumab | Up to one year | 
| Apparent volume of distribution at steady-state (Vss/F) | To characterize the PK of BMS-986205 administered alone and in combination with nivolumab | Up to one year | 
| Percent urinary recovery over 24 hours (%UR24) | To characterize the PK of BMS-986205 administered alone and in combination with nivolumab | Up to 24 hours | 
| Biomarker Availability | To characterize the pharmacodynamic activity of BMS-986205 administered alone and in combination with nivolumab | Up to one year | 
| Incidence of anti-drug antibody (ADA) | To characterize the immunogenicity of nivolumab when administered in combination with BMS-986205 | Up to one year | 
| Best Overall Response (BOR) | To investigate the preliminary anti-tumor activity of BMS-986205 administered in combination with nivolumab in advanced malignant tumors | Up to one year | 
| Duration of Response (DOR) | To investigate the preliminary anti-tumor activity of BMS-986205 administered in combination with nivolumab in advanced malignant tumors | Up to one year |