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Skin Cancer: Safety and Efficacy of Pembrolizumab (trade name Keytruda) Compared to Placebo

Research Question:
What is the safety and effectiveness of pembrolizumab compared to placebo in participants with surgically removed stage II melanoma?

Basic Study Information

Purpose:
Pembrolizumab is an antibody that blocks a protective mechanism of cancer cells and thereby allows the immune system to destroy them. This study will evaluate pembrolizumab compared to placebo in participants after the surgical removal of stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design for up to 17 cycles. Part 2 is an open-label design for participants who receive placebo in Part 1 or who stop treatment after receiving 17 cycles of pembrolizumab in Part 1. They may be eligible to receive up to 35 additional cycles of pembrolizumab in Part 2.

Location: University of Rochester Medical Center
Study Reference #: IMEL18060

Lead Researcher (Principal Investigator)

Lead Researcher: Deepak Sahasrabudhe, MD

Study Contact Information

Study Coordinator: Park Bogan
Phone: (585) 276-4415
Email: Park_Bogan@URMC.Rochester.edu

Additional Study Details

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