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OpenTrials
Completed

NCT Number: NCT06345183

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

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

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Key information

Conditions

Advanced Renal Cell Carcinoma (aRCC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardinal Health

Dublin, Ohio, 43017, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nivolumab + Ipilimumab combination therapy

Combination Product

As per product label

Pembrolizumab + Lenvatinib combination therapy

Combination Product

As per product label

Primary outcomes

  1. Participant year of birth

    Time frame: Baseline

  2. Participant sex at birth

    Time frame: Baseline

  3. Participant primary payer

    Time frame: Baseline

  4. Participant race

    Time frame: Baseline

  5. Participant ethnicity

    Time frame: Baseline

  6. Participant U.S. state of residence

    Time frame: Baseline

  7. Participant initial Renal Cell Carcinoma (RCC) diagnoses

    Time frame: Baseline

  8. American Joint Committee on Cancer (AJCC) TNM stage

    Time frame: Baseline

  9. Participant advanced/metastatic Renal Cell Carcinoma (RCC) diagnosis

    Time frame: Baseline

  10. Participant renal cell carcinoma (RCC) histology results

    Time frame: Baseline

  11. Participant tumor grade

    Time frame: Baseline

  12. Participant biomarker or genetic testing method

    Time frame: Baseline

  13. Participant molecular and/or genetic mutations reported

    Time frame: Baseline

  14. Participant site of metastatic disease

    Time frame: Index date

  15. Participant Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

    Time frame: Baseline

  16. Participant Karnofsky score (KPS)

    Time frame: Baseline

  17. Participant comorbidities and/or chronic conditions

    Time frame: Baseline

  18. Participant blood test results

    Time frame: Index date

  19. Participant Memorial Sloan Kettering Cancer Center (MSKCC) score

    Time frame: Index date

  20. Participant International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) score

    Time frame: index date

  21. Participant smoking status

    Time frame: Baseline

  22. Participant COVID-19 status

    Time frame: Baseline

  23. Participant surgical history

    Time frame: Baseline

  24. Participant radiation treatment history

    Time frame: Baseline

  25. Participant treatment regimen received

    Time frame: Index date up to 32 months

  26. Participant treatment initiation and discontinuation dates

    Time frame: Index date up to 32 months

  27. Participant rationale for discontinuation of treatment

    Time frame: Index date up to 32 months

  28. Participant radiation therapy prescribed

    Time frame: Index date up to 32 months

  29. Participant total number of radiotherapy cycles

    Time frame: Index date up to 32 months

  30. Participant initial dose and frequency/schedule of index therapy

    Time frame: Index date up to 32 months

  31. Participant index treatment dose modifications

    Time frame: Index date up to 32 months

  32. Participant rationale for dose modifications of index therapy

    Time frame: Index date up to 32 months

  33. Participant date of dose modifications of index therapy

    Time frame: Index date up to 32 months

  34. Participant last dose and frequency/schedule of index therapy

    Time frame: Index date up to 32 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2024
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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