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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Advanced Renal Cell Carcinoma (aRCC)

Treatments: Combination Product: Pembrolizumab + Lenvatinib combination therapy; Combination Product: Nivolumab + Ipilimumab combination therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT06345183

CA209-1275

Details and patient eligibility

About

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

Enrollment: 327 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

327 participants in 2 patient groups

Participants treated with Nivolumab + Ipilimumab combination therapy

Treatment:

Combination Product: Nivolumab + Ipilimumab combination therapy

Participants treated with Pembrolizumab + Lenvatinib combination therapy

Treatment:

Combination Product: Pembrolizumab + Lenvatinib combination therapy