CancerNCT07636863
Treatment Patterns and Characteristics of Patients Prescribed Opdivo Qvantig
An observational study of Cancer, run by Bristol-Myers Squibb at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Nivolumab and Subcutaneous nivolumab combined with hyaluronidase
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2025to 27 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with confirmed cancer diagnoses treated with intravenous (IV) nivolumab or subcutaneous (SC) nivolumab + hyaluronidase in U.S. community oncology practices.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, 33916
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
As per product label
Subcutaneous nivolumab combined with hyaluronidaseCombination product
As per product label
| Study group | Role | What they receive |
|---|---|---|
| IV Nivolumab | Participants who receive intravenous (IV) nivolumab in community oncology settings. Receives: Drug: Nivolumab | |
| SC Nivolumab + Hyaluronidase | Participants who receive subcutaneous (SC) nivolumab combined with hyaluronidase Receives: Combination Product: Subcutaneous nivolumab combined with hyaluronidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant age
Measured: Baseline
Participant sex
Measured: Baseline
Participant race
Measured: Baseline
Participant ethnicity
Measured: Baseline
Body mass index (kg/m²)
Measured: Baseline
Smoking status
Measured: Baseline
Cancer diagnosis
Measured: Baseline
Disease stage at initial diagnosis (Stage 0-IV, unknown)
Measured: Baseline
Eastern Cooperative Oncology Group (ECOG) performance status distribution (0-4, unknown)
Measured: Baseline
Number of participants by tumor histology categories as applicable for each disease type, including unknown.
Measured: Baseline
Duration of therapy (days)
Duration of therapy defined as time in days from first administration to last administration.
Measured: 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.
Measured: Up to 6 months
Dose administered at index (mg)
Measured: Baseline
Concomitant anti-cancer therapy use
Number and proportion of participants receiving concomitant anti-cancer therapies (yes/no).
Measured: Baseline
Location of injection site (thigh or abdomen)
Cohort 2
Measured: Up to 6 months
Number of participants with treatment switches or discontinuation.
Measured: Up to 6 months
Secondary outcomes (3)
Number of participants by education level (high school, some college, completed college, graduate school).
Measured: Baseline
Number of participants by household income categories.
Measured: Baseline
Number of participants by geographic classification (urban, suburban, rural).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start21 Aug 2025
- Primary completion22 Dec 2025
- Study completion27 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636863
- Sponsor's protocol ID
- CA209-1582
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns and Characteristics of Patients Prescribed Opdivo Qvantig by Early Adopters
- ClinicalTrials.gov ID
- NCT07636863
- Acronym / sponsor ID
- CA209-1582
- Conditions
- Cancer
- Keywords
- Nivolumab; Subcutaneous nivolumab; Intravenous nivolumab; Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 27 Mar 2026 (actual)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Nivolumab | – | Drug: NivolumabParticipants who receive intravenous (IV) nivolumab in community oncology settings. |
| SC Nivolumab + Hyaluronidase | – | Combination Product: Subcutaneous nivolumab combined with hyaluronidaseParticipants who receive subcutaneous (SC) nivolumab combined with hyaluronidase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with confirmed cancer diagnoses treated with intravenous (IV) nivolumab or subcutaneous (SC) nivolumab + hyaluronidase in U.S. community oncology practices.
Key inclusion criteria (5 listed)
- Are ≥ 18 years of age at the index date
- Have a confirmed cancer diagnosis
- Received one of the following treatments:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAs per product label | Drug | IV Nivolumab |
| Subcutaneous nivolumab combined with hyaluronidaseAs per product label | Combination product | SC Nivolumab + Hyaluronidase |
Primary outcome
Participant age
Time frame: Baseline
Participant sex
Time frame: Baseline
Participant race
Time frame: Baseline
Participant ethnicity
Time frame: Baseline
Body mass index (kg/m²)
Time frame: Baseline
Smoking status
Time frame: Baseline
Cancer diagnosis
Time frame: Baseline
Disease stage at initial diagnosis (Stage 0-IV, unknown)
Time frame: Baseline
Eastern Cooperative Oncology Group (ECOG) performance status distribution (0-4, unknown)
Time frame: Baseline
Number of participants by tumor histology categories as applicable for each disease type, including unknown.
Time frame: Baseline
Duration of therapy (days)
Time frame: Up to 6 months
Duration of therapy defined as time in days from first administration to last administration.
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.
Dose administered at index (mg)
Time frame: Baseline
Concomitant anti-cancer therapy use
Time frame: Baseline
Number and proportion of participants receiving concomitant anti-cancer therapies (yes/no).
Location of injection site (thigh or abdomen)
Time frame: Up to 6 months
Cohort 2
Number of participants with treatment switches or discontinuation.
Time frame: Up to 6 months
3 secondary outcomes
Number of participants by education level (high school, some college, completed college, graduate school).
Time frame: Baseline
Number of participants by household income categories.
Time frame: Baseline
Number of participants by geographic classification (urban, suburban, rural).
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant age (time frame: Baseline). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.