Clinical trial NCT06345183: Real-World Outcomes of Nivolumab+Ipilimumab and Pembrolizumab+Lenvatinib Among US Advanced Renal Cell Carcinoma (aRCC) Patients
Official title: Real-World Treatment Patterns and Outcomes of Advanced Renal Cell Carcinoma (aRCC) Patients Receiving Nivolumab+Ipilimumab or Pembrolizumab+Lenvatinib in U.S. Oncology Practice
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Advanced Renal Cell Carcinoma (aRCC)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-04-03
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants diagnosed with advanced Renal Cell Carcinoma (aRCC) who received Nivolumab+Ipilimumab or Pembrolizumab+Lenvatinib combination therapy in the first line (1L) setting

Brief 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


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.

Primary outcomes:
measure: Participant year of birth
timeFrame: Baseline
measure: Participant sex at birth
timeFrame: Baseline
measure: Participant primary payer
timeFrame: Baseline
measure: Participant race
timeFrame: Baseline
measure: Participant ethnicity
timeFrame: Baseline
measure: Participant U.S. state of residence
timeFrame: Baseline
measure: Participant initial Renal Cell Carcinoma (RCC) diagnoses
timeFrame: Baseline
measure: American Joint Committee on Cancer (AJCC) TNM stage
timeFrame: Baseline
measure: Participant advanced/metastatic Renal Cell Carcinoma (RCC) diagnosis
timeFrame: Baseline
measure: Participant renal cell carcinoma (RCC) histology results
timeFrame: Baseline
measure: Participant tumor grade
timeFrame: Baseline
measure: Participant biomarker or genetic testing method
timeFrame: Baseline
measure: Participant molecular and/or genetic mutations reported
timeFrame: Baseline
measure: Participant site of metastatic disease
timeFrame: Index date
measure: Participant Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
timeFrame: Baseline
measure: Participant Karnofsky score (KPS)
timeFrame: Baseline
measure: Participant comorbidities and/or chronic conditions
timeFrame: Baseline
measure: Participant blood test results
timeFrame: Index date
measure: Participant Memorial Sloan Kettering Cancer Center (MSKCC) score
timeFrame: Index date
measure: Participant International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) score
timeFrame: index date
measure: Participant smoking status
timeFrame: Baseline
measure: Participant COVID-19 status
timeFrame: Baseline
measure: Participant surgical history
timeFrame: Baseline
measure: Participant radiation treatment history
timeFrame: Baseline
measure: Participant treatment regimen received
timeFrame: Index date up to 32 months
measure: Participant treatment initiation and discontinuation dates
timeFrame: Index date up to 32 months
measure: Participant rationale for discontinuation of treatment
timeFrame: Index date up to 32 months
measure: Participant radiation therapy prescribed
timeFrame: Index date up to 32 months
measure: Participant total number of radiotherapy cycles
timeFrame: Index date up to 32 months
measure: Participant initial dose and frequency/schedule of index therapy
timeFrame: Index date up to 32 months
measure: Participant index treatment dose modifications
timeFrame: Index date up to 32 months
measure: Participant rationale for dose modifications of index therapy
timeFrame: Index date up to 32 months
measure: Participant date of dose modifications of index therapy
timeFrame: Index date up to 32 months
measure: Participant last dose and frequency/schedule of index therapy
timeFrame: Index date up to 32 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: United States
facility: Cardinal Health
state: Ohio
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: