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

NCT06345183 | Completed FDA Drug

• 1 other identifier: CA209-1275
• Study Type: observational
• Target: 327
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Advanced Renal Cell Carcinoma (aRCC)

Outcome Measures

Primary Outcomes (34)

• 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 smoking status

  Baseline

• 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

Study Arms (2)

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

Interventions

Nivolumab + Ipilimumab combination therapy COMBINATION_PRODUCT

As per product label

Participants treated with Nivolumab + Ipilimumab combination therapy

Pembrolizumab + Lenvatinib combination therapy COMBINATION_PRODUCT

As per product label

Participants treated with Pembrolizumab + Lenvatinib combination therapy

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

Adult participants diagnosed with advanced Renal Cell Carcinoma (aRCC) who received Nivolumab+Ipilimumab or Pembrolizumab+Lenvatinib combination therapy in the first line (1L) setting

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Cardinal Health

Dublin, Ohio, 43017, United States

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

Nivolumab; pembrolizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: February 19, 2024
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)