Clinical Trial: Pembrolizumab in Advanced/Metastatic Acral Lentiginous Melanoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: An Open-label Phase II Study of Pembrolizumab in East Asian Patients With Advanced/Metastatic Acral Lentiginous Melanoma
Brief Summary: To determine the Overall Response Rate (ORR), as defined as rate of complete response (CR) and partial response (PR) as per RECIST 1.1 in biological treatment-naïve patients with acral lentiginous melanoma treated with pembrolizumab
Detailed Summary:
Sponsor: Chinese University of Hong Kong
Current Primary Outcome: Overall Response Rate (ORR) [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- response duration [ Time Frame: 2 years ]
- Clinical Benefit Rate (CBR) [ Time Frame: 2 years ]
- Progression-free survival (PFS) [ Time Frame: 3 years ]
- Overall survival (OS) [ Time Frame: 3 years ]
- Response assessment as per the Immune-related Response Criteria (irRC) [ Time Frame: 2 years ]
- adverse events [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: Chinese University of Hong Kong
Dates:
Date Received: August 7, 2016
Date Started: February 15, 2017
Date Completion: September 2020
Last Updated: February 16, 2017
Last Verified: February 2017
