Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called V940 (the study drug) when it is given with pembrolizumab to people who have had surgery to remove their bladder, kidney, or other organs for muscle-invasive urothelial carcinoma. We want to know how well this combination works compared to taking pembrolizumab on its own.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Have MIUC originating in the lower tract (bladder, urethra) or upper tract (renal pelvis, ureter)</li>
<li>Have undergone radical resection for MIUC no more than 8 weeks before joining the study</li>
<li>Have not received any previous anticancer therapy after surgery</li>
<li>Have not received prior treatment with a cancer vaccine</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: kellie.shobe@duke.edu">kellie.shobe@duke.edu</a> or 919-684-8299.
<li>Have MIUC originating in the lower tract (bladder, urethra) or upper tract (renal pelvis, ureter)</li>
<li>Have undergone radical resection for MIUC no more than 8 weeks before joining the study</li>
<li>Have not received any previous anticancer therapy after surgery</li>
<li>Have not received prior treatment with a cancer vaccine</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: kellie.shobe@duke.edu">kellie.shobe@duke.edu</a> or 919-684-8299.
What is Involved?
If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:<ul>
<li>Have a physical exam</li>
<li>Have an ECG</li>
<li>Have blood draws</li>
<li>Have a tumor biopsy</li></ul>
If you are eligible to join, you will get a random assignment (like a coin flip) to 1 of 2 groups:<ul>
<li>Group 1 will get the study drug and pembrolizumab</li>
<li>Group 2 will get a placebo (inactive substance) and pembrolizumab</li></ul>
Pembrolizumab is given by a needle in the vein. This is called intravenous (IV) infusion. It is given once every 6 weeks for up to 9 doses over approximately 1 year.
The study drug and placebo are given as shots in a muscle (shoulder, thigh, or buttock). The shots are given once every 3 weeks for up to 9 doses over approximately 6 months.
At various visits you will complete physical exams, have blood draws, an exam of your bladder, scans, ECG, and biopsy.
Your length of participation will depend on how you respond to your assigned study regimen.
<li>Have a physical exam</li>
<li>Have an ECG</li>
<li>Have blood draws</li>
<li>Have a tumor biopsy</li></ul>
If you are eligible to join, you will get a random assignment (like a coin flip) to 1 of 2 groups:<ul>
<li>Group 1 will get the study drug and pembrolizumab</li>
<li>Group 2 will get a placebo (inactive substance) and pembrolizumab</li></ul>
Pembrolizumab is given by a needle in the vein. This is called intravenous (IV) infusion. It is given once every 6 weeks for up to 9 doses over approximately 1 year.
The study drug and placebo are given as shots in a muscle (shoulder, thigh, or buttock). The shots are given once every 3 weeks for up to 9 doses over approximately 6 months.
At various visits you will complete physical exams, have blood draws, an exam of your bladder, scans, ECG, and biopsy.
Your length of participation will depend on how you respond to your assigned study regimen.
Study Details
Full Title
A Phase 2, Randomized, Double-blind, Placebo- and Active-comparator-controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-risk Muscle-invasive Urothelial Carcinoma Post-radical Resection
Principal Investigator
Christopher
Hoimes
Protocol Number
PRO00114499
NCT ID
NCT06305767
Phase
II
Enrollment Status
Open to Enrollment