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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | monotherapy and combination therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986205 | Drug | Specified dose on specified days |
| |
| Nivolumab |
| 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 |
| 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) |
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Inclusion Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Chuo-ku | Tokyo | 1040045 | Japan |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| ID | Term |
|---|---|
| C000630574 | linrodostat |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Biological |
Specified dose on specified day |
|
|
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 |
| FDA Safety Alerts and Recalls | View source |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |