Real-World Outcomes of Nivolumab+Ipilimumab and Pembrolizumab+Lenvatinib Among US Advanced Renal Cell Carcinoma (aRCC) Patients

November 5, 2025 updated by: Bristol-Myers Squibb

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
327

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

  • United States
    • Ohio
      • Dublin, Ohio, United States, 43017
        • Cardinal Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  1. Age 18 years and older with diagnosis of Advanced Renal Cell Carcinoma (aRCC) with predominantly clear-cell histology

  2. Received any of the following therapies in the first-line setting:

    1. Nivolumab + Ipilimumab between 8/1/2021 and 6 months prior to data collection
    2. Pembrolizumab + Lenvatinib between 8/1/2021and 6 months prior to data collection
  3. 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)

Exclusion Criteria:

  1. Receipt of any immunotherapy or tyrosine kinase inhibitor (TKI) therapy as part of a Randomized Controlled Trial (RCT)
  2. Participant received any systemic therapy for Advanced Renal Cell Carcinoma (aRCC) prior to index therapy, including neoadjuvant or adjuvant therapy
  3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants treated with Nivolumab + Ipilimumab combination therapy
Combination product: Nivolumab + Ipilimumab combination therapy
As per product label
Participants treated with Pembrolizumab + Lenvatinib combination therapy
Combination product: Pembrolizumab + Lenvatinib combination therapy
As per product label

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Participant smoking status
Time Frame: Baseline
Baseline
Participant year of birth
Time Frame: Baseline
Baseline
Participant sex at birth
Time Frame: Baseline
Baseline
Participant primary payer
Time Frame: Baseline
Baseline
Participant race
Time Frame: Baseline
Baseline
Participant ethnicity
Time Frame: Baseline
Baseline
Participant U.S. state of residence
Time Frame: Baseline
Baseline
Participant initial Renal Cell Carcinoma (RCC) diagnoses
Time Frame: Baseline
Baseline
American Joint Committee on Cancer (AJCC) TNM stage
Time Frame: Baseline
Baseline
Participant advanced/metastatic Renal Cell Carcinoma (RCC) diagnosis
Time Frame: Baseline
Baseline
Participant renal cell carcinoma (RCC) histology results
Time Frame: Baseline
Baseline
Participant tumor grade
Time Frame: Baseline
Baseline
Participant biomarker or genetic testing method
Time Frame: Baseline
Baseline
Participant molecular and/or genetic mutations reported
Time Frame: Baseline
Baseline
Participant site of metastatic disease
Time Frame: Index date
Index date
Participant Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Time Frame: Baseline
Baseline
Participant Karnofsky score (KPS)
Time Frame: Baseline
Baseline
Participant comorbidities and/or chronic conditions
Time Frame: Baseline
Baseline
Participant blood test results
Time Frame: Index date
Index date
Participant Memorial Sloan Kettering Cancer Center (MSKCC) score
Time Frame: Index date
Index date
Participant International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) score
Time Frame: index date
index date
Participant COVID-19 status
Time Frame: Baseline
Baseline
Participant surgical history
Time Frame: Baseline
Baseline
Participant radiation treatment history
Time Frame: Baseline
Baseline
Participant treatment regimen received
Time Frame: Index date up to 32 months
Index date up to 32 months
Participant treatment initiation and discontinuation dates
Time Frame: Index date up to 32 months
Index date up to 32 months
Participant rationale for discontinuation of treatment
Time Frame: Index date up to 32 months
Index date up to 32 months
Participant radiation therapy prescribed
Time Frame: Index date up to 32 months
Index date up to 32 months
Participant total number of radiotherapy cycles
Time Frame: Index date up to 32 months
Index date up to 32 months
Participant initial dose and frequency/schedule of index therapy
Time Frame: Index date up to 32 months
Index date up to 32 months
Participant index treatment dose modifications
Time Frame: Index date up to 32 months
Index date up to 32 months
Participant rationale for dose modifications of index therapy
Time Frame: Index date up to 32 months
Index date up to 32 months
Participant date of dose modifications of index therapy
Time Frame: Index date up to 32 months
Index date up to 32 months
Participant last dose and frequency/schedule of index therapy
Time Frame: Index date up to 32 months
Index date up to 32 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA209-1275

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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