NCT06151236

Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma

A Phase 2, Open Label, Single Arm Clinical Trial of Neoadjuvant Nivolumab and Relatlimab in Stage I To III Resectable Merkel Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Melanoma Institute Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test neoadjuvant dual immunotherapy in Merkel cell carcinoma with the aim to improve recurrence-free survival

Detailed description

This is a phase 2, open label, single cohort, single centre, clinical trial of neoadjuvant immunotherapy with dual inhibition of PD-1 and LAG-3 immune checkpoint pathways. The hypothesis is that neoadjuvant therapy produces a higher pathological response rate (pCR) and a longer recurrence-free survival in a cohort of treatment-naïve patients with resectable stage I (≥10 mm) to stage III Merkel cell carcinoma compared to neoadjuvant nivolumab monotherapy in Checkmate 358 (n=123, NCT02488759, historical control).

Conditions

• Merkel Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination	Dual inhibition of the distinct LAG3 and PD-1 checkpoint pathways

Timeline

• Start date: 2024-03-11
• Primary completion: 2026-12-01
• Completion: 2034-04-01
• First posted: 2023-11-30
• Last updated: 2026-02-17

Locations

1 site across 1 country: Australia