A Phase III Study of Tivozanib in Combination with Nivolumab versus Tivozanib Alone in People with Renal Cell Carcinoma that Grew after Immunotherapy

Share

Full Title

TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination with Nivolumab to Tivozanib Monotherapy in Subjects with Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line has an Immune Checkpoint Inhibitor

Purpose

Tivozanib and nivolumab are medications each used individually to treat advanced renal cell carcinoma (kidney cancer) that has continued to grow despite treatment. In this study, researchers want to see if combining tivozanib and nivolumab is more effective than tivozanib alone. Participants will be randomly assigned to receive both medications or just tivozanib.

Tivozanib blocks the development of the blood vessels that trigger the growth of cancer cells and is taken orally (by mouth). Nivolumab immunotherapy boosts the power of the immune system to detect and destroy cancer cells. It is given intravenously.

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have advanced renal cell carcinoma that has continued to grow despite one or two prior regimens of therapy, one of which was an immune checkpoint inhibitor (such as nivolumab or pembrolizumab).
  • At least 2 weeks must pass between the completion of prior chemotherapy, immunotherapy, or radiation therapy and receipt of the study treatment.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Robert Motzer at 646-888-4722.

Protocol

21-467

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators