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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)
Registration Number
NCT06345183
Lead Sponsor
Bristol-Myers Squibb
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
All
Target Recruitment
327
Inclusion Criteria

Inclusion Criteria:<br><br> 1. Age 18 years and older with diagnosis of Advanced Renal Cell Carcinoma (aRCC) with<br> predominantly clear-cell histology<br><br> 2. Received any of the following therapies in the first-line setting:<br><br> 1. Nivolumab + Ipilimumab between 8/1/2021 and 6 months prior to data collection<br><br> 2. Pembrolizumab + Lenvatinib between 8/1/2021and 6 months prior to data<br> collection<br><br> 3. Participant had at least 6 months of follow-up from initiation of index treatment<br> (patients who deceased prior to 6 months since index treatment initiation would<br> still be eligible)<br><br>Exclusion Criteria:<br><br> 1. Receipt of any immunotherapy or tyrosine kinase inhibitor (TKI) therapy as part of a<br> Randomized Controlled Trial (RCT)<br><br> 2. Participant received any systemic therapy for Advanced Renal Cell Carcinoma (aRCC)<br> prior to index therapy, including neoadjuvant or adjuvant therapy<br><br> 3. Any active malignancy in the 3 years prior to initiation of 1L therapy for aRCC,<br> except for locally curable cancers that have been cured, such as basal or squamous<br> cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix, or<br> breast cancer, or localized prostate cancer with a Gleason score =3+4 that has been<br> treated more than 12 months prior to full study screening and considered to have a<br> very low risk of recurrence.

Exclusion Criteria

Not provided

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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