Study of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-041/KEYNOTE-041)

Phase 1 Completed 42 enrolled Merck Sharp & Dohme LLC

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study will assess the safety, tolerability, and efficacy of every-3-week dosing (Q3W) of pembrolizumab (MK-3475) in participants with advanced melanoma; participants may receive pembrolizumab for up to 2 years if deriving clinical benefit. The primary study hypothesis is that treatment with single agent pembrolizumab will result in a clinically meaningful overall response rate.

Timeline

Start: 2014-07-15
Primary completion: 2017-08-31
Completion: 2017-08-31

Outcome

Met primary endpoint

registry analysis (superiority test); Advanced Cutaneous Melanoma; p = 0.0216; Exact Binomial Distribution; note: One-sided p-value. NCT02180061 ↗

registry NUMBER Advanced Cutaneous Melanoma: 24.1 (10.3 to 43.5) Percentage of Participants NCT02180061 ↗

Publications

Results Yamazaki N, Takenouchi T, Fujimoto M, Ihn H, Uchi H, Inozume T, Kiyohara Y, Uhara H, Nakagawa K, Furukawa H, Wada H, Noguchi K, Shimamoto T, Yokota K. Phase 1b study of pembrolizumab (MK-3475; anti-PD-1 monoclonal antibody) in Japanese patients with advanced melanoma (KEYNOTE-041). Cancer Chemother Pharmacol. 2017 Apr;79(4):651-660. doi: 10.1007/s00280-016-3237-x. Epub 2017 Mar 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pembrolizumab	Monoclonal antibody	2 mg/kg	Intravenous