A031801: Advanced Renal Cell Carcinoma with Bone Metastasis

Purpose of this Study

We are doing this study to find out if using Radium-223 dichloride (the study drug) in combination with cabozantinib is a safe and effective treatment for advanced RCC that has spread to the bone. We want to know if this combination is potentially better than the standard treatment of cabozantinib on its own.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with RCC
  • Have at least 1 metastatic bone lesion that has not been treated yet
  • Have not been treated with cabozantinib in the past
For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will be randomly assigned (like a coin flip) to 1 of 2 groups:
  • You may be assigned to take cabozantinib + the study drug; OR
  • You may be assigned to take cabozantinib on its own (the standard treatment)
Cabozantinib is a pill that you take by mouth. The study drug is an infusion that you get through a vein in your arm (IV). You will get up to 6 doses of the study drug if you are assigned to the study drug group. Participants in either group will take cabozantinib for as long as they and the study doctor think is necessary and beneficial.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

Alliance A031801:A Phase II Randomized Trial of Radium-223 Dichloride and Cabozantinib in Patients with Advanced Renal Cell Carcinoma with Bone Metastasis (RADICAL)

Principal Investigator

Michael
Harrison

Protocol Number

PRO00111064

NCT ID

NCT04071223

Phase

II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov