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A Phase II Randomized Open label Study of High Dose Interleukin 2 vs High Dose Interleukin 2 plus Entinostat in Untreated Advanced Renal Cell Carcinoma (GU17-289)

Study on the Effects of High Dose Investigational Medication in Renal Cell Carcinoma

Recruiting
18 years and older
All
Phase N/A

This study investigates the effects of using a high dose of a protein called interleukin (IL-2) along with a substance called Entinostat in treating renal cell carcinoma, a type of kidney cancer. The purpose of this study is to see if adding Entinostat to IL-2 can help control cancer better than using IL-2 alone. Renal cell carcinoma is a cancer that starts in the kidneys and can spread to other parts of the body.

Participants in the study will receive either high dose IL-2 alone or high dose IL-2 combined with Entinostat. This will help researchers compare how well these treatments work. Participants will not be paid for their participation in this study.

  • Who can participate: Adults with metastatic or surgically unresectable renal cell carcinoma, specifically clear cell carcinoma, can participate. Patients should have had up to two prior therapies, including one with an immune checkpoint inhibitor, and must have measurable lesions.
  • Study details: Participants will receive either high dose IL-2 alone or high dose IL-2 with Entinostat. A placebo is not used in this study.
Study details
    renal cell carcinoma

TX8766

19 February 2024

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