Merck-U02-Substudy 02B - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if two experimental drugs called MK-7684 and MK-1308 are safe and effective treatments for melanoma. We will combine these drugs with other cancer drugs in this study.

What is the Condition Being Studied?

Melanoma

Who Can Participate in the Study?

Adults ages 18+ who:
- Are diagnosed with stage III or IV melanoma

For more information about who can be in this study, please contact the study team at ivy.belskie@duke.edu.

Age Group
Adults

What is Involved?

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 a tumor biopsy
- Have heart scans (ECG and echocardiogram)
- Have images taken (CT or MRI)

If you are found to be eligible, you will continue on to the study dosing period. During this period, you will:
- Be randomly assigned to 1 of 4 groups
-- Group 1 will get pembrolizumab and MK-7684
-- Group 2 will get pembrolizumab alone
-- Group 3 will get MK-1308A (pembrolizumab + MK-1308)
-- Group 4 will get MK-1308A and lenvatinib

Pembrolizumab, MK-7684, and MK-1308 are all given as intravenous (IV) infusions. Lenvatinib is a capsule you take by mouth.

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 02B
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00107691
NCT: NCT04305054
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698