Advanced Renal Cell Carcinoma (aRCC)NCT06345183
Real-World Outcomes of Nivolumab+Ipilimumab and Pembrolizumab+Lenvatinib Among US Advanced Renal Cell Carcinoma (aRCC) Patients
An observational study of Advanced Renal Cell Carcinoma (aRCC), run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This observational study aims to describe demographic, clinical characteristics, treatment patterns outcomes of participants with advanced Renal Cell Carcinoma (aRCC) receiving either Nivolumab + Ipilimumab, or Pembrolizumab + Lenvatinib combination therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Renal Cell Carcinoma (aRCC)
- What is being tested?
- Nivolumab + Ipilimumab combination therapy and Pembrolizumab + Lenvatinib combination therapy
- How many people
- 327 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2024to 4 Apr 2024
- 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: Adult participants diagnosed with advanced Renal Cell Carcinoma (aRCC) who received Nivolumab+Ipilimumab or Pembrolizumab+Lenvatinib combination therapy in the first line (1L) setting
Who may be able to join
- Age 18 years and older with diagnosis of Advanced Renal Cell Carcinoma (aRCC) with predominantly clear-cell histology
- Received any of the following therapies in the first-line setting:
- Nivolumab + Ipilimumab between 8/1/2021 and 6 months prior to data collection
- Pembrolizumab + Lenvatinib between 8/1/2021and 6 months prior to data collection
- Participant had at least 6 months of follow-up from initiation of index treatment (patients who deceased prior to 6 months since index treatment initiation would still be eligible)
Who cannot join
- Receipt of any immunotherapy or tyrosine kinase inhibitor (TKI) therapy as part of a Randomized Controlled Trial (RCT)
- Participant received any systemic therapy for Advanced Renal Cell Carcinoma (aRCC) prior to index therapy, including neoadjuvant or adjuvant therapy
- Any active malignancy in the 3 years prior to initiation of 1L therapy for aRCC, except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix, or breast cancer, or localized prostate cancer with a Gleason score ≤3+4 that has been treated more than 12 months prior to full study screening and considered to have a very low risk of recurrence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-World Treatment Patterns and Outcomes of Advanced Renal Cell Carcinoma (aRCC) Patients Receiving Nivolumab+Ipilimumab or Pembrolizumab+Lenvatinib in U.S. Oncology Practice
This observational study aims to describe demographic, clinical characteristics, treatment patterns outcomes of participants with advanced Renal Cell Carcinoma (aRCC) receiving either Nivolumab + Ipilimumab, or Pembrolizumab + Lenvatinib combination therapy
- Conditions
- Advanced Renal Cell Carcinoma (aRCC)
- Being tested
- Nivolumab + Ipilimumab combination therapy, Pembrolizumab + Lenvatinib combination therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab + Ipilimumab combination therapyCombination product
As per product label
Pembrolizumab + Lenvatinib combination therapyCombination product
As per product label
| Study group | Role | What they receive |
|---|---|---|
| Participants treated with Nivolumab + Ipilimumab combination therapy | Not described Receives: Combination Product: Nivolumab + Ipilimumab combination therapy | |
| Participants treated with Pembrolizumab + Lenvatinib combination therapy | Not described Receives: Combination Product: Pembrolizumab + Lenvatinib combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant year of birth
Measured: Baseline
Participant sex at birth
Measured: Baseline
Participant primary payer
Measured: Baseline
Participant race
Measured: Baseline
Participant ethnicity
Measured: Baseline
Participant U.S. state of residence
Measured: Baseline
Participant initial Renal Cell Carcinoma (RCC) diagnoses
Measured: Baseline
American Joint Committee on Cancer (AJCC) TNM stage
Measured: Baseline
Participant advanced/metastatic Renal Cell Carcinoma (RCC) diagnosis
Measured: Baseline
Participant renal cell carcinoma (RCC) histology results
Measured: Baseline
Participant tumor grade
Measured: Baseline
Participant biomarker or genetic testing method
Measured: Baseline
Participant molecular and/or genetic mutations reported
Measured: Baseline
Participant site of metastatic disease
Measured: Index date
Participant Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Measured: Baseline
Participant Karnofsky score (KPS)
Measured: Baseline
Participant comorbidities and/or chronic conditions
Measured: Baseline
Participant blood test results
Measured: Index date
Participant Memorial Sloan Kettering Cancer Center (MSKCC) score
Measured: Index date
Participant International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) score
Measured: index date
Participant smoking status
Measured: Baseline
Participant COVID-19 status
Measured: Baseline
Participant surgical history
Measured: Baseline
Participant radiation treatment history
Measured: Baseline
Participant treatment regimen received
Measured: Index date up to 32 months
Participant treatment initiation and discontinuation dates
Measured: Index date up to 32 months
Participant rationale for discontinuation of treatment
Measured: Index date up to 32 months
Participant radiation therapy prescribed
Measured: Index date up to 32 months
Participant total number of radiotherapy cycles
Measured: Index date up to 32 months
Participant initial dose and frequency/schedule of index therapy
Measured: Index date up to 32 months
Participant index treatment dose modifications
Measured: Index date up to 32 months
Participant rationale for dose modifications of index therapy
Measured: Index date up to 32 months
Participant date of dose modifications of index therapy
Measured: Index date up to 32 months
Participant last dose and frequency/schedule of index therapy
Measured: Index date up to 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start19 Feb 2024
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Renal Cell Carcinoma (aRCC)Studies 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
- Other
- Enrolment
- 327 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
- NCT06345183
- Sponsor's protocol ID
- CA209-1275
- Status last verified
- Nov 2025
- First submitted
- 28 Mar 2024
- Last updated
- 6 Nov 2025
- 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 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Treatment Patterns and Outcomes of Advanced Renal Cell Carcinoma (aRCC) Patients Receiving Nivolumab+Ipilimumab or Pembrolizumab+Lenvatinib in U.S. Oncology Practice
- ClinicalTrials.gov ID
- NCT06345183
- Acronym / sponsor ID
- CA209-1275
- Conditions
- Advanced Renal Cell Carcinoma (aRCC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 3 Apr 2024 (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 observational study aims to describe demographic, clinical characteristics, treatment patterns outcomes of participants with advanced Renal Cell Carcinoma (aRCC) receiving either Nivolumab + Ipilimumab, or Pembrolizumab + Lenvatinib combination therapy
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants treated with Nivolumab + Ipilimumab combination therapy | – | Combination Product: Nivolumab + Ipilimumab combination therapy |
| Participants treated with Pembrolizumab + Lenvatinib combination therapy | – | Combination Product: Pembrolizumab + Lenvatinib combination therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants diagnosed with advanced Renal Cell Carcinoma (aRCC) who received Nivolumab+Ipilimumab or Pembrolizumab+Lenvatinib combination therapy in the first line (1L) setting
Key inclusion criteria (5 listed)
- Age 18 years and older with diagnosis of Advanced Renal Cell Carcinoma (aRCC) with predominantly clear-cell histology
- Received any of the following therapies in the first-line setting:
- Participant had at least 6 months of follow-up from initiation of index treatment (patients who deceased prior to 6 months since index treatment initiation would still be eligible)
Key exclusion criteria (3 listed)
- Receipt of any immunotherapy or tyrosine kinase inhibitor (TKI) therapy as part of a Randomized Controlled Trial (RCT)
- Participant received any systemic therapy for Advanced Renal Cell Carcinoma (aRCC) prior to index therapy, including neoadjuvant or adjuvant therapy
- Any active malignancy in the 3 years prior to initiation of 1L therapy for aRCC, except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix, or breast cancer, or localized prostate cancer with a Gleason score ≤3+4 that has been treated more than 12 months prior to full study screening and considered to have a very low risk of recurrence.
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 |
|---|---|---|
| Nivolumab + Ipilimumab combination therapyAs per product label | Combination product | Participants treated with Nivolumab + Ipilimumab combination therapy |
| Pembrolizumab + Lenvatinib combination therapyAs per product label | Combination product | Participants treated with Pembrolizumab + Lenvatinib combination therapy |
Primary outcome
Participant year of birth
Time frame: Baseline
Participant sex at birth
Time frame: Baseline
Participant primary payer
Time frame: Baseline
Participant race
Time frame: Baseline
Participant ethnicity
Time frame: Baseline
Participant U.S. state of residence
Time frame: Baseline
Participant initial Renal Cell Carcinoma (RCC) diagnoses
Time frame: Baseline
American Joint Committee on Cancer (AJCC) TNM stage
Time frame: Baseline
Participant advanced/metastatic Renal Cell Carcinoma (RCC) diagnosis
Time frame: Baseline
Participant renal cell carcinoma (RCC) histology results
Time frame: Baseline
Participant tumor grade
Time frame: Baseline
Participant biomarker or genetic testing method
Time frame: Baseline
Participant molecular and/or genetic mutations reported
Time frame: Baseline
Participant site of metastatic disease
Time frame: Index date
Participant Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Time frame: Baseline
Participant Karnofsky score (KPS)
Time frame: Baseline
Participant comorbidities and/or chronic conditions
Time frame: Baseline
Participant blood test results
Time frame: Index date
Participant Memorial Sloan Kettering Cancer Center (MSKCC) score
Time frame: Index date
Participant International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) score
Time frame: index date
Participant smoking status
Time frame: Baseline
Participant COVID-19 status
Time frame: Baseline
Participant surgical history
Time frame: Baseline
Participant radiation treatment history
Time frame: Baseline
Participant treatment regimen received
Time frame: Index date up to 32 months
Participant treatment initiation and discontinuation dates
Time frame: Index date up to 32 months
Participant rationale for discontinuation of treatment
Time frame: Index date up to 32 months
Participant radiation therapy prescribed
Time frame: Index date up to 32 months
Participant total number of radiotherapy cycles
Time frame: Index date up to 32 months
Participant initial dose and frequency/schedule of index therapy
Time frame: Index date up to 32 months
Participant index treatment dose modifications
Time frame: Index date up to 32 months
Participant rationale for dose modifications of index therapy
Time frame: Index date up to 32 months
Participant date of dose modifications of index therapy
Time frame: Index date up to 32 months
Participant last dose and frequency/schedule of index therapy
Time frame: Index date up to 32 months
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 6 Nov 2025.
- 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 Advanced Renal Cell Carcinoma (aRCC), 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 6 Nov 2025. 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 year of birth (time frame: Baseline). The study lists 34 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 6 Nov 2025.