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OpenTrials
Completed

NCT Number: NCT07636863

Treatment Patterns and Characteristics of Patients Prescribed Opdivo Qvantig

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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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, 33916, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Drug

As per product label

Subcutaneous nivolumab combined with hyaluronidase

Combination Product

As per product label

Primary outcomes

  1. Participant age

    Time frame: Baseline

  2. Participant sex

    Time frame: Baseline

  3. Participant race

    Time frame: Baseline

  4. Participant ethnicity

    Time frame: Baseline

  5. Body mass index (kg/m²)

    Time frame: Baseline

  6. Smoking status

    Time frame: Baseline

  7. Cancer diagnosis

    Time frame: Baseline

  8. Disease stage at initial diagnosis (Stage 0-IV, unknown)

    Time frame: Baseline

  9. Eastern Cooperative Oncology Group (ECOG) performance status distribution (0-4, unknown)

    Time frame: Baseline

  10. Number of participants by tumor histology categories as applicable for each disease type, including unknown.

    Time frame: Baseline

  11. Duration of therapy (days)

    Time frame: Up to 6 months

    Duration of therapy defined as time in days from first administration to last administration.

  12. Duration of planned therapy (days)

    Time frame: Up to 6 months

    Duration of planned therapy defined as time in days from start date to last ordered treatment.

  13. Dose administered at index (mg)

    Time frame: Baseline

  14. Concomitant anti-cancer therapy use

    Time frame: Baseline

    Number and proportion of participants receiving concomitant anti-cancer therapies (yes/no).

  15. Location of injection site (thigh or abdomen)

    Time frame: Up to 6 months

    Cohort 2

  16. Number of participants with treatment switches or discontinuation.

    Time frame: Up to 6 months

Secondary outcomes

  1. Number of participants by education level (high school, some college, completed college, graduate school).

    Time frame: Baseline

  2. Number of participants by household income categories.

    Time frame: Baseline

  3. Number of participants by geographic classification (urban, suburban, rural).

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Treatment Patterns and Characteristics of Patients Prescribed Opdivo Qvantig by Early Adopters

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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