CompletedNot Applicable

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

United States327 participantsStarted 2024-02-19

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✓. Nivolumab + Ipilimumab between 8/1/2021 and 6 months prior to data collection
✓. Pembrolizumab + Lenvatinib between 8/1/2021and 6 months prior to data collection
✓. 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

✕. Receipt of any immunotherapy or tyrosine kinase inhibitor (TKI) therapy as part of a Randomized Controlled Trial (RCT)
✕. Participant received any systemic therapy for Advanced Renal Cell Carcinoma (aRCC) prior to index therapy, including neoadjuvant or adjuvant therapy
✕. 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.

What they're measuring

Participant year of birth

Timeframe: Baseline

Participant sex at birth

Timeframe: Baseline

Participant primary payer

Timeframe: Baseline

Participant race

Timeframe: Baseline

Participant ethnicity

Timeframe: Baseline

Participant U.S. state of residence

Timeframe: Baseline

Participant initial Renal Cell Carcinoma (RCC) diagnoses

Timeframe: Baseline

American Joint Committee on Cancer (AJCC) TNM stage

Timeframe: Baseline

Participant advanced/metastatic Renal Cell Carcinoma (RCC) diagnosis

Trial details

NCT IDNCT06345183

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-04-04

View on ClinicalTrials.gov More Advanced Renal Cell Carcinoma (aRCC) trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✓. Nivolumab + Ipilimumab between 8/1/2021 and 6 months prior to data collection
✓. Pembrolizumab + Lenvatinib between 8/1/2021and 6 months prior to data collection
✓. 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

✕. Receipt of any immunotherapy or tyrosine kinase inhibitor (TKI) therapy as part of a Randomized Controlled Trial (RCT)
✕. Participant received any systemic therapy for Advanced Renal Cell Carcinoma (aRCC) prior to index therapy, including neoadjuvant or adjuvant therapy
✕. 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.

What they're measuring

Participant year of birth

Timeframe: Baseline

Participant sex at birth

Timeframe: Baseline

Participant primary payer

Timeframe: Baseline

Participant race

Timeframe: Baseline

Participant ethnicity

Timeframe: Baseline

Participant U.S. state of residence

Timeframe: Baseline

Participant initial Renal Cell Carcinoma (RCC) diagnoses

Timeframe: Baseline

American Joint Committee on Cancer (AJCC) TNM stage

Timeframe: Baseline

Participant advanced/metastatic Renal Cell Carcinoma (RCC) diagnosis