Clinical trial · Observational
Real-World Outcomes of Nivolumab+Ipilimumab and Pembrolizumab+Lenvatinib Among US Advanced Renal Cell Carcinoma (aRCC) Patients
Real-World Treatment Patterns and Outcomes of Advanced Renal Cell Carcinoma (aRCC) Patients Receiving Nivolumab+Ipilimumab or Pembrolizumab+Lenvatinib in U.S. Oncology Practice
NCT06345183CI-TRIAL-00097041completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Renal Cell Carcinoma (aRCC) | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab + Ipilimumab combination therapy | Combination Product | — | UNRESOLVED |
| Pembrolizumab + Lenvatinib combination therapy | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Participants treated with Nivolumab + Ipilimumab combination therapy
- interventionNames
- Combination Product: Nivolumab + Ipilimumab combination therapy
- label
- Participants treated with Pembrolizumab + Lenvatinib combination therapy
- interventionNames
- Combination Product: Pembrolizumab + Lenvatinib combination therapy
Primary outcomes (34)
- measure
- Participant year of birth
- timeFrame
- Baseline
- measure
- Participant sex at birth
- timeFrame
- Baseline
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.