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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants treated with Nivolumab + Ipilimumab combination therapy |
| ||
| Participants treated with Pembrolizumab + Lenvatinib combination therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab + Ipilimumab combination therapy | Combination Product | As per product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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:
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Adult participants diagnosed with advanced Renal Cell Carcinoma (aRCC) who received Nivolumab+Ipilimumab or Pembrolizumab+Lenvatinib combination therapy in the first line (1L) setting
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardinal Health | Dublin | Ohio | 43017 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| Pembrolizumab + Lenvatinib combination therapy | Combination Product | As per product label |
|
| 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 |
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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