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This study will characterize the movement of drugs within the body, evaluate safety and determine to which extent the body can process relatlimab in combination with nivolumab in subjects with certain advanced tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nivolumab + relatlimab + rHuPH20 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| relatlimab | Drug | Specified dose on Specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| maximum observed serum concentration (Cmax) | approximately 60 days | |
| time of maximum observed serum concentration (Tmax) | approximately 60 days | |
| area under the time-concentration curve over the dosing interval AUC (TAU) | approximately 60 days | |
| Observed concentration at the end of the dosing interval (Ctau) | approximately 60 days | |
| Incidence of Serious Adverse Events (SAEs) | approximately 2 years | |
| Incidence of Adverse Events (AEs) | approximately 2 years | |
| Incidence of Adverse Events leading to discontinuation | approximately 2 years | |
| Number of deaths | approximately 2 years | |
| Number of laboratory abnormalities | approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverese Events (AEs) in the broad SMQ of Anaphylactic Reaction | approximately 2 years | |
| Number of events within the hypersensitivity/infusion reaction select AE category | approximately 2 years |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion Criteria could apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Hackensack | New Jersey | 07601 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000721227 | relatlimab |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| nivolumab |
| Drug |
Specified dose on Specified days |
|
|
| rHuPH20 | Drug | Specified dose on Specified days |
|
|
| Incidence of anti-relatlimab antibodies and neutralizing antibodies (if applicable) | approximately 2 years |
| Incidence of anti-nivolumab antibodies and neutralizing antibodies (if applicable) | approximately 2 years |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |