Advanced Cancer
Conditions
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
Interventions
DRUGBMS-986205
Specified dose on specified days
BIOLOGICALNivolumab
Specified dose on specified day
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) | 15 months | Safety and Tolerability |
| Incidence of Serious Adverse Events (SAEs) | 15 months | Safety and Tolerability |
| Incidence of Death | 15 months | Safety and Tolerability |
| Incidence of Laboratory Abnormalities | 15 months | Safety and Tolerability |
| AEs leading to discontinuation | Up to one year | Safety and Tolerability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Incidence of anti-drug antibody (ADA) | Up to one year | To characterize the immunogenicity of nivolumab when administered in combination with BMS-986205 |
| 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 |
| 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 |
| 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 |
| Apparent total body clearance (CLT/F) | Up to one year | To characterize the PK of BMS-986205 administered alone and in combination with nivolumab |
Countries
Japan
Outcome results
None listed