Treatment Patterns and Characteristics of Patients Prescribed Opdivo Qvantig

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: Nivolumab; Combination product: Subcutaneous nivolumab combined with hyaluronidase

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Myers, Florida, United States, 33916
      • Florida Cancer Specialists & Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with confirmed cancer diagnoses treated with intravenous (IV) nivolumab or subcutaneous (SC) nivolumab + hyaluronidase in U.S. community oncology practices.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IV Nivolumab; Participants who receive intravenous (IV) nivolumab in community oncology settings.	Drug: Nivolumab; As per product label
SC Nivolumab + Hyaluronidase; Participants who receive subcutaneous (SC) nivolumab combined with hyaluronidase	Combination product: Subcutaneous nivolumab combined with hyaluronidase; As per product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant age		Baseline
Participant sex		Baseline
Participant race		Baseline
Participant ethnicity		Baseline
Smoking status		Baseline
Body mass index (kg/m²)		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
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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2025
• Primary Completion (Actual): December 22, 2025
• Study Completion (Actual): March 27, 2026

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Nivolumab; Subcutaneous nivolumab; Intravenous nivolumab; Cancer
• Additional Relevant MeSH Terms: Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nivolumab; Hyaluronoglucosaminidase
• Other Study ID Numbers: CA209-1582

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No