Purpose of this Study
We are doing this study to find out if an experimental drug called V940 (the study drug) is a safe and effective option for melanoma patients who have had surgery when it is given in combination with pembrolizumab. We want to know how well the study drug compares to pembrolizumab taken on its own.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with stage 2, 3, or 4 melanoma</li>
<li>Have had melanoma resection surgery</li>
<li>Have not had any drug treatment yet for melanoma (radiation treatment is okay)</li></ul>
For more information about this study, please contact the study team at danielle.myers@duke.edu.
<li>Are diagnosed with stage 2, 3, or 4 melanoma</li>
<li>Have had melanoma resection surgery</li>
<li>Have not had any drug treatment yet for melanoma (radiation treatment is okay)</li></ul>
For more information about this study, please contact the study team at danielle.myers@duke.edu.
What is Involved?
If you choose to join this study, you will get a random assignment (by chance) to 1 of 2 groups:<ul>
<li>If you are in Group 1, will get the study drug and pembrolizumab. You will get pembrolizumab as an intravenous infusion (IV) into a vein in your arm every 6 weeks. You will get up to 9 doses of pembrolizumab. You will also get the study drug as an injection (shot) into a muscle every 3 weeks. You will get up to 9 doses of the study drug.</li>
<li>If you are in Group 2, will get a placebo (inactive substance) and pembrolizumab. You will get pembrolizumab as an intravenous infusion into a vein in your arm every 6 weeks. You will get up to 9 doses of pembrolizumab. You will also get injections of the placebo every 3 weeks. You will get up to 9 doses of placebo.</li></ul>
This is a "blind" study, so you will not know if you are in Group 1 or 2 while you are participating. You have a 2-in-3 chance of being in Group 1, and a 1-in-3 chance of being in Group 2. If it ever becomes medically necessary to know which group you are in, we can find out.
<li>If you are in Group 1, will get the study drug and pembrolizumab. You will get pembrolizumab as an intravenous infusion (IV) into a vein in your arm every 6 weeks. You will get up to 9 doses of pembrolizumab. You will also get the study drug as an injection (shot) into a muscle every 3 weeks. You will get up to 9 doses of the study drug.</li>
<li>If you are in Group 2, will get a placebo (inactive substance) and pembrolizumab. You will get pembrolizumab as an intravenous infusion into a vein in your arm every 6 weeks. You will get up to 9 doses of pembrolizumab. You will also get injections of the placebo every 3 weeks. You will get up to 9 doses of placebo.</li></ul>
This is a "blind" study, so you will not know if you are in Group 1 or 2 while you are participating. You have a 2-in-3 chance of being in Group 1, and a 1-in-3 chance of being in Group 2. If it ever becomes medically necessary to know which group you are in, we can find out.
Study Details
Full Title
A Phase 3, 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 Stage II-IV
Melanoma
Controlled Clinical study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus
Adjuvant Placebo Plus Pembrolizumab in Participants With High-Risk Stage II-IV
Melanoma
Principal Investigator
April
Salama
Protocol Number
PRO00113415
NCT ID
NCT05933577
Phase
III
Enrollment Status
Open to Enrollment