A Study of BMS-986205 Given in Combination With Nivolumab in Patients With Advanced Tumors
- Conditions
- Advanced Cancer
- Interventions
- Drug: BMS-986205Biological: Nivolumab
- Registration Number
- NCT03192943
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose Escalation BMS-986205 monotherapy and combination therapy Dose Escalation Nivolumab monotherapy and combination therapy
- Primary Outcome Measures
Name Time Method AEs leading to discontinuation Up to one year Safety and Tolerability
Incidence of Death 15 months Safety and Tolerability
Incidence of Serious Adverse Events (SAEs) 15 months Safety and Tolerability
Incidence of Adverse Events (AEs) 15 months Safety and Tolerability
Incidence of Laboratory Abnormalities 15 months Safety and Tolerability
- Secondary Outcome Measures
Name Time Method Apparent volume of distribution at steady-state (Vss/F) Up to one year To characterize the PK of BMS-986205 administered alone and in combination with nivolumab
Best Overall Response (BOR) Up to one year To investigate the preliminary anti-tumor activity of BMS-986205 administered in combination with nivolumab in advanced malignant tumors
Time of maximum observed plasma concentration (Tmax) Up to one year To characterize the PK of BMS-986205 administered alone and in combination with nivolumab
Trough observed plasma concentration at the end of the dosing interval (Ctrough) Up to one year To characterize the PK of BMS-986205 administered alone and in combination with nivolumab
Percent urinary recovery over 24 hours (%UR24) Up to 24 hours To characterize the PK of BMS-986205 administered alone and in combination with nivolumab
Biomarker Availability Up to one year To characterize the pharmacodynamic activity of BMS-986205 administered alone and in combination with nivolumab
Maximum observed plasma concentration (Cmax) Up to one year To characterize the Pharmacokinetics (PK) of BMS-986205 administered alone and in combination with nivolumab
Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] Up to one year To characterize the PK of BMS-986205 administered alone and in combination with nivolumab
Apparent total body clearance (CLT/F) Up to one year To characterize the PK of BMS-986205 administered alone and in combination with nivolumab
Incidence of anti-drug antibody (ADA) Up to one year To characterize the immunogenicity of nivolumab when administered in combination with BMS-986205
Duration of Response (DOR) Up to one year To investigate the preliminary anti-tumor activity of BMS-986205 administered in combination with nivolumab in advanced malignant tumors
Trial Locations
- Locations (1)
Local Institution
🇯🇵Chuo-ku, Tokyo, Japan