Study on XL092 and Nivolumab vs Sunitinib for Advanced or Metastatic Non-Clear Cell Kidney Cancer

Sponsor: Exelixis

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05678673

This clinical trial is comparing two treatments for patients with advanced or metastatic non-clear cell kidney cancer that cannot be surgically removed. The study aims to determine which treatment is more effective in managing the disease.

Patient Parameters

Program Overview

This study is testing two different treatments for people with advanced or metastatic non-clear cell kidney cancer (nccRCC) that cannot be removed by surgery. Participants will receive either a combination of XL092 and nivolumab or the drug sunitinib. The trial is open to adults who have not received prior systemic cancer treatment for their condition.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with non-clear cell kidney cancer that cannot be surgically removed, is advanced, or has spread to other parts of the body. Specific types of this cancer, such as papillary and unclassified, are included.
  • Have measurable cancer as determined by medical scans.
  • Provide a previous tumor sample for analysis.
  • Have recovered from any side effects of past treatments to a certain level, unless deemed not significant by the doctor.
  • Be 18 years or older.
  • Have a Karnofsky Performance Status score of 70% or higher, indicating the ability to care for oneself with some assistance.
  • Have adequate organ and bone marrow function based on recent tests.
  • Agree to use effective birth control methods if sexually active and fertile.
  • Women of childbearing potential must not be pregnant at the start of the study.

Exclusion Criteria

  • Have specific types of kidney cancer, such as chromophobe or renal medullary carcinoma.
  • Have received prior systemic cancer treatment for advanced or metastatic non-clear cell kidney cancer, except for certain adjuvant therapies.
  • Have had recent radiation therapy for bone metastases or other areas within specified timeframes.
  • Have untreated or unstable brain metastases unless treated and stable for at least 4 weeks.
  • Are taking certain blood thinners or platelet inhibitors that cannot be adjusted.
  • Have had major surgery within 8 weeks or minor surgery within 10 days before starting the study.
  • Have a heart condition indicated by a specific ECG reading.
  • Are pregnant or breastfeeding.
  • Have received a live vaccine within 30 days before starting the study.

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