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

Active, not recruiting

• Conditions: Advanced Renal Cell Carcinoma (aRCC)
• Interventions: Combination Product: Pembrolizumab + Lenvatinib combination therapy; Combination Product: Nivolumab + Ipilimumab combination therapy

• Registration Number: NCT06345183
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-19
• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-03
• Primary Completion: 2024-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 327

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants treated with Pembrolizumab + Lenvatinib combination therapy	Pembrolizumab + Lenvatinib combination therapy	-
Participants treated with Nivolumab + Ipilimumab combination therapy	Nivolumab + Ipilimumab combination therapy	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Cardinal Health; 🇺🇸 Dublin, Ohio, United States