Spots Global Cancer Trial Database for Neoadjuvant Pembrolizumab and Lenvatinib for Mucosal Melanoma
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Trial Identification
Brief Title: Neoadjuvant Pembrolizumab and Lenvatinib for Mucosal Melanoma
Official Title: A Multicentre, Open Label, Phase II Study to Determine the Response to Neoadjuvant Pembrolizumab and Lenvatinib Followed by Adjuvant Treatment With Pembrolizumab and Lenvatinib in Mucosal Melanoma
Study ID: NCT05545969
Conditions
Study Description
Brief Summary: In many cancers, early stage diagnosis and early treatment offers the best chance of a prolonged recurrence free- and overall survival. Neoadjuvant immunotherapy involves administering immune checkpoint inhibitors before surgical resection in high-risk resectable disease, such as mucosal melanoma. In resectable cancers, immune checkpoint inhibitors can enhance anti-tumour immunity by exploiting a competent immune system prior to surgery. Activating antigen-specific T cells found in the primary or baseline tumour continue to exert anti-tumour effects on remaining neoplastic cells after the resection of the original tumour, potentially preventing recurrences from occurring. In resectable mucosal melanoma, an opportunity exists to improve clinical outcomes with the addition of neoadjuvant and adjuvant systemic therapy with nivolumab and lenvatinib as an adjunct to surgery.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Melanoma Institute Australia, Wollstonecraft, New South Wales, Australia
Contact Details
Name: Georgina Long, MBBS, PhD
Affiliation: Melanoma Institute Australia
Role: PRINCIPAL_INVESTIGATOR
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