Treatment Patterns and Characteristics of Patients Prescribed Opdivo Qvantig

NCT07636863 | Completed FDA Drug

• 1 other identifier: CA209-1582
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Nivolumab; Subcutaneous nivolumab; Intravenous nivolumab; Cancer

Outcome Measures

Primary Outcomes (16)

• 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

• 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 Outcomes (3)

• 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

Study Arms (2)

IV Nivolumab

Participants who receive intravenous (IV) nivolumab in community oncology settings.

Drug: Nivolumab

SC Nivolumab + Hyaluronidase

Participants who receive subcutaneous (SC) nivolumab combined with hyaluronidase

Combination Product: Subcutaneous nivolumab combined with hyaluronidase

Interventions

Nivolumab DRUG

As per product label

IV Nivolumab

Subcutaneous nivolumab combined with hyaluronidase COMBINATION_PRODUCT

As per product label

SC Nivolumab + Hyaluronidase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, 33916, United States

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Neoplasms

Interventions

Nivolumab; Hyaluronoglucosaminidase

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start: August 21, 2025
• Primary Completion: December 22, 2025
• Study Completion: March 27, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)