Cancer
Conditions
Keywords
Nivolumab; Subcutaneous nivolumab; Intravenous nivolumab; Cancer
Brief summary
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.
Interventions
DRUGNivolumab
As per product label
COMBINATION_PRODUCTSubcutaneous nivolumab combined with hyaluronidase
As per product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are ≥ 18 years of age at the index date * Have a confirmed cancer diagnosis * Received one of the following treatments: * Intravenous (IV) nivolumab * Subcutaneous (SC) nivolumab + hyaluronidase
Exclusion criteria
* Currently receiving a clinical trial therapy at index * Currently receiving treatment for another active concurrent primary cancer diagnosis * Received IV nivolumab or SC nivolumab + hyaluronidase off-label
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Up to 6 months | Duration of therapy defined as time in days from first administration to last administration. |
| Duration of planned therapy (days) | Up to 6 months | Duration of planned therapy defined as time in days from start date to last ordered treatment. |
| Dose administered at index (mg) | Baseline | — |
| Concomitant anti-cancer therapy use | Baseline | Number and proportion of participants receiving concomitant anti-cancer therapies (yes/no). |
| Location of injection site (thigh or abdomen) | Up to 6 months | Cohort 2 |
| Number of participants with treatment switches or discontinuation. | Up to 6 months | — |
Secondary
| Measure | 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 |
| Number of participants by geographic classification (urban, suburban, rural). | Baseline |
Countries
United States
Contacts
STUDY_DIRECTORBristol Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed