Study Comparing Subcutaneous and Intravenous Nivolumab in Patients with Advanced or Metastatic Clear Cell Kidney Cancer

Sponsor: Bristol-Myers Squibb

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04810078

Provider View

This clinical trial is testing two ways of giving the drug nivolumab—under the skin (subcutaneous) and through a vein (intravenous)—to see which is more effective and safe for patients with advanced or metastatic clear cell kidney cancer who have already received treatment.

Patient Parameters

Program Overview

The study aims to compare the levels, effectiveness, safety, and tolerability of nivolumab when given under the skin versus through a vein in patients with advanced or metastatic clear cell kidney cancer who have been treated before. A part of the study will also look at how similar the drug levels are when nivolumab is made using two different methods.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of kidney cancer with clear cell features, possibly with sarcomatoid features.
  • The cancer is advanced or has spread and cannot be cured with surgery or radiation.
  • Have measurable cancer as per specific medical criteria within 28 days before joining the study.
  • Have received no more than two previous treatments for cancer.
  • The cancer has worsened or the patient cannot tolerate the last treatment within six months before joining the study.
  • Have a performance status score of 70 or higher, indicating the ability to care for oneself with some help.
  • Agree to use specific birth control methods, if applicable.

Exclusion Criteria

  • Have untreated or symptomatic cancer that has spread to the brain.
  • Have another active cancer needing treatment or a history of cancer within the last two years.
  • Have an active or suspected autoimmune disease.
  • Have HIV with a recent serious infection or low CD4 count, unless on stable antiretroviral therapy and monitored by a healthcare provider.
  • Have serious or uncontrolled medical conditions, including recent severe COVID-19 infection.
  • Have previously received certain immune-targeting treatments.
  • Have received a live vaccine within 30 days before starting the study treatment.

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