RecruitingPhase 2NCT06288191

Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma

A Phase 2, Open Label, Single Arm, Clinical Trial of Neoadjuvant Nivolumab and Relatlimab in Stage II To IV (M0) Resectable Cutaneous Squamous Cell Carcinoma


Sponsor

Melanoma Institute Australia

Enrollment

20 participants

Start Date

Jun 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this study is to test neoadjuvant therapy with the dual inhibition of Programmed cell death protein 1 (PD-1) and lymphocyte activation gene 3 (LAG-3) immune checkpoint pathways in a cohort of treatment-naïve, resectable stage II to IV cutaneous squamous cell carcinoma on the pathological response rate (pCR) and recurrence-free survival.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving immunotherapy drugs nivolumab and relatlimab before surgery (neoadjuvant) can shrink cutaneous squamous cell carcinoma (a type of skin cancer) and improve surgical outcomes. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of cutaneous squamous cell carcinoma (skin cancer, not head and neck mucosal) - Your cancer is at stage II, III, or IV and is considered surgically removable - Your tumor is measurable on scans **You may NOT be eligible if...** - Your cancer has spread to distant organs beyond the regional lymph nodes - You have active autoimmune diseases that would be worsened by immunotherapy - You have had prior treatment with drugs targeting the same immune pathways (PD-1/LAG-3) - You are pregnant or breastfeeding 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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NCT06288191


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