Merck-U02-Substudy 02A_PD-1 Refractory Melanoma
What is the Purpose of this Study?
The study is divided into two periods: a screening period and a study dosing period.
If you choose to join this study, during the screening period you will:
- Have physical exams
- Have blood draws
- Have other tests done to assess your eligibility
The screening period will last for about one month.
If you are found to be eligible, you will continue on to the study dosing period. During this period, you will:
- Be randomly assigned (fair, 50/50 chance) to 1 of 2 groups
-- Group 1 will get pembrolizumab combined with two study drugs called MK-1308 and MK-7684
-- Group 2 will get pembrolizumab combined with lenvatinib and MK-1308
If you choose to join this study, during the screening period you will:
- Have physical exams
- Have blood draws
- Have other tests done to assess your eligibility
The screening period will last for about one month.
If you are found to be eligible, you will continue on to the study dosing period. During this period, you will:
- Be randomly assigned (fair, 50/50 chance) to 1 of 2 groups
-- Group 1 will get pembrolizumab combined with two study drugs called MK-1308 and MK-7684
-- Group 2 will get pembrolizumab combined with lenvatinib and MK-1308
What is the Condition Being Studied?
PD-1 (Programmed Cell Death Protein 1) Resistant Melanoma
Who Can Participate in this Study?
Adults ages 18+ who:
- Are diagnosed with melanoma
- Did not respond to previous treatment that used anti-PD-1/L1 therapy
For more information about who can be in this study, please contact the study team at ivy.belskie@duke.edu.
Age Group
Adults
Participating Institutions
What is Involved?
We are doing this study to find out if combining pembrolizumab and different experimental drugs are safe and effective treatments for people with melanoma that does not improve after standard therapy.
Study Details
Full Title
A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma-Substudy 02A
Principal Investigator
Protocol Number
IRB:
PRO00107343
NCT:
NCT04305041
ClinicalTrials.gov
View on ClinicalTrials.gov