drugset / Trial / NCT05545969

Neoadjuvant Pembrolizumab and Lenvatinib for Mucosal Melanoma

NCT05545969 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-03
Primary completion
2026-05
Completion
2036-05

Outcome

Outcome not reported

Stopped (Business): “Insufficient funding”

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenvatinib Small molecule — Oral
Subject Pembrolizumab Monoclonal antibody — —

Indications