Actively Recruiting
Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma
Led by Melanoma Institute Australia · Updated on 2025-12-16
20
Participants Needed
1
Research Sites
627 weeks
Total Duration
On this page
Sponsors
M
Melanoma Institute Australia
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Written informed consent provided
- Histologically confirmed, resectable stage II to IV cutaneous squamous cell carcinoma
- Measurable disease by RECIST 1.1 within 2 weeks before treatment
- Tumor suitable for core biopsy that has not been previously irradiated
- Prior radiotherapy allowed only at sites not seen at baseline
- ECOG performance status of 0 or 1
- Adequate blood, liver, kidney, and thyroid function
- Expected life expectancy greater than 12 months
- Negative pregnancy test for women of childbearing potential within 24 to 72 hours before first dose
- Use of effective contraception during treatment and for 5 months after last dose
You will not qualify if you...
- Evidence of distant metastasis
- Squamous cell carcinoma of eyelid, vulva, penis, or perianus
- Contraindications to nivolumab or relatlimab
- Previous treatment with PD-1, CTLA-4, PDL-1, or LAG-3 antibodies or other immunotherapies
- Active autoimmune disease or need for chronic steroids (except stable hormone replacement)
- Immunodeficiency or recent immunosuppressive therapy
- Other active malignancies within 3 years except certain treated skin and in situ cancers
- Uncontrolled or significant cardiovascular disease
- Elevated troponin levels above specified limits
- History of pneumonitis or interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- History of allogenic tissue or organ transplant
- Known HIV, active Hepatitis B or C infection
- Pregnant or breastfeeding females
- Medical or social conditions preventing scheduled assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia, 2065
Actively Recruiting
Research Team
M
Monica Osorio
CONTACT
M
Maria Gonzalez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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