A Phase I/II Study of Pazopanib plus MK-3475 (Pembrolizumab) Immunotherapy in Patients with Previously Untreated, Inoperable Advanced Kidney Cancer

Full Title

A Phase I/II Study to Assess the Safety and Efficacy of Pazopanib and MK-3475 in Patients with Advanced Renal Cell Carcinoma

Purpose

Pazopanib is a drug approved for treating a type of kidney cancer called renal cell carcinoma (RCC). It works by inhibiting the development of the blood vessels that tumors need to grow and spread. Yet despite this therapy, the cancer often comes back.

Doctors are interested in seeing if adding the drug MK-3475 (pembrolizumab) to pazopanib therapy is more effective than pazopanib alone. Pembrolizumab will be assessed in patients with advanced RCC that cannot be surgically removed and has not yet been treated.

Pembrolizumab is a protein called an antibody which binds to PD-1, a protein on T cells (a type of white blood cell). It is a form of immunotherapy. It is hoped that when pembrolizumab binds to PD-1, it will "turn on" the T cells and cause the immune system to detect and destroy cancer cells. Pembrolizumab was recently approved by the FDA to treat a different cancer, metastatic malignant melanoma. It is given intravenously (by vein), while pazopanib is taken orally (by mouth).

This study has two parts. Patients enrolled in the first part will all receive the combination of both medications, to see what side effects arise when both are given together and which doses are best tolerated for the combination. Once this part is concluded, patients enrolled in part 2 of the trial will be randomly assigned (by chance, per choice of a computer) to receive one of three possible treatments: pazopanib alone, pembrolizumab alone, or the combination of both. The purpose of part 2 is to directly compare the effectiveness of therapy between these drugs when given individually or together.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable, previously untreated advanced RCC.
  • Tumor tissue from a prior biopsy or surgery must be available for research testing. If not, patients must undergo a new biopsy to obtain tumor tissue for this purpose.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Martin Voss at 646-422-4631.

Protocol

14-074

Phase

I/II

Investigator

Co-Investigators

Locations