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This study will review medical records of adults with cancer who received nivolumab either as an intravenous (IV) infusion or as a subcutaneous (under the skin) injection in community oncology clinics in the United States. The study will describe who receives each type of treatment, how the treatments are used, and selected safety events such as reactions at the injection or infusion site and infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Nivolumab | Participants who receive intravenous (IV) nivolumab in community oncology settings. |
| |
| SC Nivolumab + Hyaluronidase | Participants who receive subcutaneous (SC) nivolumab combined with hyaluronidase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | As per product label |
| |
| Subcutaneous nivolumab combined with hyaluronidase |
| Measure | Description | Time Frame |
|---|---|---|
| Participant age | Baseline | |
| Participant sex | Baseline | |
| Participant race | Baseline | |
| Participant ethnicity | Baseline | |
| Body mass index (kg/m²) | Baseline | |
| Smoking status | Baseline | |
| Cancer diagnosis | Baseline | |
| Disease stage at initial diagnosis (Stage 0-IV, unknown) | Baseline | |
| Eastern Cooperative Oncology Group (ECOG) performance status distribution (0-4, unknown) | Baseline | |
| Number of participants by tumor histology categories as applicable for each disease type, including unknown. | Baseline | |
| Duration of therapy (days) | Duration of therapy defined as time in days from first administration to last administration. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants by education level (high school, some college, completed college, graduate school). | Baseline | |
| Number of participants by household income categories. | Baseline | |
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Inclusion Criteria:
Are ≥ 18 years of age at the index date
Have a confirmed cancer diagnosis
Received one of the following treatments:
Exclusion Criteria:
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Adults with confirmed cancer diagnoses treated with intravenous (IV) nivolumab or subcutaneous (SC) nivolumab + hyaluronidase in U.S. community oncology practices.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cancer Specialists & Research Institute | Fort Myers | Florida | 33916 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D006821 | Hyaluronoglucosaminidase |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Combination Product |
As per product label |
|
| Duration of planned therapy (days) | Duration of planned therapy defined as time in days from start date to last ordered treatment. | Up to 6 months |
| Dose administered at index (mg) | Baseline |
| Concomitant anti-cancer therapy use | Number and proportion of participants receiving concomitant anti-cancer therapies (yes/no). | Baseline |
| Location of injection site (thigh or abdomen) | Cohort 2 | Up to 6 months |
| Number of participants with treatment switches or discontinuation. | Up to 6 months |
| Number of participants by geographic classification (urban, suburban, rural). |
| Baseline |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006026 | Glycoside Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D011133 | Polysaccharide-Lyases |
| D019757 | Carbon-Oxygen Lyases |
| D008190 | Lyases |