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

Bristol-Myers Squibb327 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

327

Conditions

Advanced Renal Cell Carcinoma (aRCC)

Interventions

Nivolumab + Ipilimumab combination therapyCOMBINATION_PRODUCT

As per product label

Pembrolizumab + Lenvatinib combination therapyCOMBINATION_PRODUCT

As per product label

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cardinal Health

Dublin, Ohio, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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