Advanced Renal Cell Carcinoma (aRCC)
Conditions
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
Interventions
COMBINATION_PRODUCTNivolumab + Ipilimumab combination therapy
As per product label
COMBINATION_PRODUCTPembrolizumab + Lenvatinib combination therapy
As per product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant radiation treatment history | Baseline |
| Participant treatment regimen received | Index date up to 32 months |
| 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 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 COVID-19 status | Baseline |
| Participant surgical history | Baseline |
| Participant comorbidities and/or chronic conditions | Baseline |
| 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 |
Countries
United States
Outcome results
None listed