Clinical trial

Real-World Treatment Patterns and Outcomes of Advanced Renal Cell Carcinoma (aRCC) Patients Receiving Nivolumab+Ipilimumab or Pembrolizumab+Lenvatinib in U.S. Oncology Practice

Name

CA209-1275

Description

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

Trial arms

Trial start

2024-02-19

Estimated PCD

2024-04-01

Trial end

2024-12-31

Status

Recruiting

Treatment

Nivolumab + Ipilimumab combination therapy

As per product label

Arms:

Participants treated with Nivolumab + Ipilimumab combination therapy

Pembrolizumab + Lenvatinib combination therapy

As per product label

Arms:

Participants treated with Pembrolizumab + Lenvatinib combination therapy

Size

350

Primary endpoint

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

Eligibility criteria

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 350, 'type': 'ESTIMATED'}}

Updated at

2024-04-03

1 organization

2 products

1 indication

Product

Nivolumab + Ipilimumab

Indication

Advanced Renal Cell Carcinoma

Product

Pembrolizumab + Lenvatinib

Organization

Bristol-Myers Squibb