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

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: Completed
• Conditions: Advanced Renal Cell Carcinoma (aRCC)
• Intervention / Treatment: Combination product: Nivolumab + Ipilimumab combination therapy; Combination product: Pembrolizumab + Lenvatinib combination therapy

• Study Type: Observational
• Enrollment (Actual): 327

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

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

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): February 19, 2024
• Primary Completion (Actual): April 4, 2024
• Study Completion (Actual): April 4, 2024

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: November 5, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma, Renal Cell; Carcinoma; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nivolumab; pembrolizumab
• Other Study ID 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