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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002993-38 | EudraCT Number |
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The purpose of this study is to compare the drug levels, immunogenicity and safety of Nivolumab Process D to Nivolumab Process C after complete resection of stage IIIa/b/c/d or stage IV melanoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Process C) | Active Comparator |
| |
| Arm B (Process D) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve in one dosing interval (AUC[TAU]) (336 h) | Over the dosing interval at Week 1 and Week 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Over the dosing interval at Week 1 and Week 17 | |
| Observed serum concentration at the end of a dosing interval (Ctau) | Over the dosing interval at Week 1 and Week 17 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria 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 - 0006 | Hartford | Connecticut | 06106 | United States | ||
| Local Institution - 0008 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls |
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| Time of maximum observed plasma concentration (Tmax) | Over the dosing interval at Week 1 and Week 17 |
| Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) | Through Week 51 Day 1 |
| Number of Participants With Serious Adverse Events (SAEs) | Up to 65 weeks |
| Number of Participants With Adverse Events leading to Discontinuation | Up to 65 weeks |
| Number of Participants With Adverse Events (AEs) | Up to 65 weeks |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Up to 65 weeks |
| Number of Participants with AEs leading to death | Up to 65 weeks |
| Minneapolis |
| Minnesota |
| 55407 |
| United States |
| Local Institution - 0035 | Charlotte | North Carolina | 28204 | United States |
| Local Institution - 0043 | Pittsburgh | Pennsylvania | 15213 | United States |
| Local Institution - 0046 | Buenos Aires | 1431 | Argentina |
| Local Institution - 0001 | Wollstonecraft | New South Wales | 2065 | Australia |
| Local Institution - 0036 | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Local Institution - 0037 | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Local Institution - 0039 | Barretos | São Paulo | 14780-070 | Brazil |
| Local Institution - 0038 | Cerqueira César | São Paulo | 01246-000 | Brazil |
| Local Institution - 0040 | São José do Rio Preto | São Paulo | 15090000 | Brazil |
| Local Institution - 0041 | Rio de Janeiro | 20230-130 | Brazil |
| Local Institution - 0013 | Edmonton | T6X 1E8 | Canada |
| Local Institution - 0024 | Independencia | Santiago Metropolitan | Chile |
| Local Institution - 0045 | Santiago | Santiago Metropolitan | 8420383 | Chile |
| Local Institution - 0023 | Santiago | Santiago Metropolitan | Chile |
| Local Institution - 0022 | Santiago | 0 | Chile |
| Local Institution - 0009 | Marseille | 13385 | France |
| Local Institution - 0010 | Nantes | 44093 | France |
| Local Institution - 0011 | Paris | 75475 | France |
| Local Institution - 0018 | Wilton | CORK | T12 DC4A | Ireland |
| Local Institution - 0032 | Dublin | Ireland |
| Local Institution - 0014 | Bergamo | 24127 | Italy |
| Local Institution - 0015 | Padova | 35128 | Italy |
| Local Institution - 0016 | Siena | 53100 | Italy |
| Local Institution - 0034 | Tlalpan | Mexico City | 14080 | Mexico |
| Local Institution - 0033 | Monterrey | Nuevo León | 64460 | Mexico |
| Local Institution - 0031 | San Pedro Garza García | Nuevo León | 66278 | Mexico |
| Local Institution - 0005 | Auckland | 1023 | New Zealand |
| Local Institution - 0004 | Christchurch | 0 | New Zealand |
| Local Institution - 0003 | Wellington | 6021 | New Zealand |
| Local Institution - 0017 | Warsaw | 02-781 | Poland |
| Local Institution - 0030 | Timișoara | 300696 | Romania |
| Local Institution - 0029 | Badalona-barcelona | 08916 | Spain |
| Local Institution - 0026 | Madrid | 28007 | Spain |
| Local Institution - 0027 | Madrid | 28040 | Spain |
| Local Institution - 0028 | Málaga | 29010 | 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 |
|---|---|
| D000077594 | Nivolumab |
| 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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