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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000132-25 | EudraCT Number |
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Business objectives have changed.
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The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) of relatlimab in combination with ipilimumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Escalation Phase | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relatlimab | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks]) | |
| Number of Participants with Serious Adverse Events (SAEs) | Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks]) | |
| Number of Participants With Adverse Events Including Dose Limiting Toxicity | Up to 28 days after last study drug dose (approximately up to 2 years) | |
| Number of Participants with AEs resulting in Discontinuation | Up to end of study (approximately 2.4 years) | |
| Number of Participants with AEs resulting in Death | Up to end of study (approximately 2.4 years) | |
| Number of Participants with AEs resulting in Laboratory Abnormalities | Up to end of study (approximately 2.4 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0023 | Tucson | Arizona | 85724 | United States | ||
| Local Institution - 0002 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| Ipilimumab | Drug | Specified dose on specified days |
|
| Los Angeles |
| California |
| 90033 |
| United States |
| Local Institution - 0005 | Los Angeles | California | 90033 | United States |
| Local Institution - 0001 | Santa Monica | California | 90404 | United States |
| Local Institution - 0015 | Miami | Florida | 33136 | United States |
| Local Institution - 0004 | Chicago | Illinois | 60611 | United States |
| Local Institution - 0003 | Ann Arbor | Michigan | 48109 | United States |
| Local Institution - 0008 | Morristown | New Jersey | 07960 | United States |
| Local Institution - 0018 | Brussels | Brussels Capital | 1000 | Belgium |
| Local Institution - 0017 | Antwerp | 2020 | Belgium |
| Local Institution - 0016 | Brussels | 1090 | Belgium |
| Local Institution - 0038 | Brussels | 1200 | Belgium |
| Local Institution - 0044 | Ottawa | Ontario | K1H 8L6 | Canada |
| Local Institution - 0037 | Erlangen | 91054 | Germany |
| Local Institution - 0034 | Essen | 45147 | Germany |
| Local Institution - 0036 | Gera | 07548 | Germany |
| Local Institution - 0035 | Hanover | 30625 | Germany |
| Local Institution - 0033 | Heidelberg | 69120 | Germany |
| Local Institution - 0032 | Lübeck | 23562 | Germany |
| Local Institution - 0040 | Nuremberg | 90419 | Germany |
| Local Institution - 0053 | Padova | 35128 | Italy |
| Local Institution - 0055 | Siena | 53100 | Italy |
| Local Institution - 0026 | Barcelona | 08035 | Spain |
| Local Institution - 0030 | Córdoba | 14004 | Spain |
| Local Institution - 0031 | Donostia / San Sebastian | 20014 | Spain |
| Local Institution - 0027 | Hospitalet de Llobregat - Barcelona | 08908 | Spain |
| Local Institution - 0029 | Madrid | 28034 | Spain |
| Local Institution - 0028 | Valencia | 46009 | Spain |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000721227 | relatlimab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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