Purpose of this Study
We are doing this study to compare two treatment options for PRCC. We want to know if adding an experimental drug called atezolimumab (the study drug) to the typical drug used in PRCC treatment, cabozantinib, can improve outcomes or extend survival time.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with metastatic PRCC, either type 1 or type 2</li>
<li>Do not require specific treatment for active brain metastases at the time of joining the study and won't require treatment until the first cycle of the study regimen is done</li>
<li>Have never used cabozantinib</li>
<li>Have not been treated with PD-1/PD-L1 checkpoint inhibitors for any reason within the past 6 months</li>
<li>Have not have received more than one prior systemic therapy for advanced or metastatic renal cell carcinoma with the exception of another VEGF inhibitor FDA-approved for advanced RCC</li></ul>
For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.
<li>Are diagnosed with metastatic PRCC, either type 1 or type 2</li>
<li>Do not require specific treatment for active brain metastases at the time of joining the study and won't require treatment until the first cycle of the study regimen is done</li>
<li>Have never used cabozantinib</li>
<li>Have not been treated with PD-1/PD-L1 checkpoint inhibitors for any reason within the past 6 months</li>
<li>Have not have received more than one prior systemic therapy for advanced or metastatic renal cell carcinoma with the exception of another VEGF inhibitor FDA-approved for advanced RCC</li></ul>
For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.
What is Involved?
If you choose to join this study, you will be randomly assigned (like a coin flip) to 1 of 2 groups:<ul>
<li>One group will get the cabozantinib. You will take cabozantinib tablets every day. Each three-week period is called a "cycle."</li>
<li>The other group will cabozantinib in combination with the study drug. You will take cabozantinib tablets every day. Each three-week period is called a cycle. The study drug is given intravenously (IV) through a vein in your arm on the first day of each cycle.</li></ul>
<li>One group will get the cabozantinib. You will take cabozantinib tablets every day. Each three-week period is called a "cycle."</li>
<li>The other group will cabozantinib in combination with the study drug. You will take cabozantinib tablets every day. Each three-week period is called a cycle. The study drug is given intravenously (IV) through a vein in your arm on the first day of each cycle.</li></ul>
Study Details
Full Title
S2200: A Phase II Randomized Trial of Cabozantinib (NSC #761968) with or Without Atezolizumab (NSC #783608) in Patients with Advanced Papillary Renal Cell Carcinoma (PAPMET2)
Principal Investigator
Michael
Harrison
Protocol Number
PRO00113295
NCT ID
NCT05411081
Phase
II
Enrollment Status
Open to Enrollment