RecruitingPhase 2NCT06151236

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


Sponsor

Melanoma Institute Australia

Enrollment

20 participants

Start Date

Mar 11, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether giving immunotherapy drugs nivolumab (anti-PD-1) and relatlimab (anti-LAG-3) before surgery can shrink Merkel cell carcinoma tumors and improve surgical and long-term outcomes. Merkel cell carcinoma is a rare but aggressive form of skin cancer. This neoadjuvant (pre-surgery) approach aims to boost the immune system's ability to fight the cancer before it is removed. **You may be eligible if...** - You are 18 years or older - You have been confirmed to have resectable (surgically removable) Merkel cell carcinoma, stage I (≥ 10 mm), IIA, IIB, or III - You have measurable disease on imaging and are in good health (ECOG 0–1) - You have a life expectancy of more than 12 months **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have had prior immunotherapy (anti-PD-1, CTLA-4, PD-L1, or LAG-3 antibodies) - You have an active autoimmune disease or are on significant immunosuppressive therapy - You are known to be HIV positive or have active hepatitis B or C - You are pregnant or breastfeeding - You have serious heart disease including active myocarditis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination

Dual inhibition of the distinct LAG3 and PD-1 checkpoint pathways


Locations(1)

Melanoma Institute Australia

Wollstonecraft, New South Wales, Australia

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NCT06151236


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