Actively Recruiting
Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma
Led by Melanoma Institute Australia · Updated on 2026-02-17
20
Participants Needed
1
Research Sites
524 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 clinical trial is to test neoadjuvant dual immunotherapy in Merkel cell carcinoma with the aim to improve recurrence-free survival
CONDITIONS
Official Title
Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Provided written consent
- Histologically confirmed, resectable Merkel cell carcinoma at stage I (≥10 mm), IIA, IIB, or III
- In-transit metastases allowed if they can be fully removed
- Measurable disease by RECIST 1.1 criteria
- Previous radiotherapy allowed if disease has progressed since treatment
- Availability of archival or new biopsy tissue from tumor lesions
- ECOG performance status 0-1
- Adequate organ function based on blood tests
- Life expectancy greater than 12 months
- Female participants must use effective contraception during treatment and for 5 months after last dose
You will not qualify if you...
- Evidence of distant metastases by clinical, radiographic, or pathological evaluation
- Contraindications to nivolumab or relatlimab
- Prior exposure to anti-PD-1, CTLA-4, PDL-1, LAG-3 antibodies, or other experimental immunotherapies or chemotherapy
- Active autoimmune disease or need for chronic steroid therapy except hormone replacement
- Immunodeficiency diagnosis or chronic steroid therapy over 10 mg prednisone daily
- Active malignancy within past 3 years, except chronic lymphocytic leukemia
- Uncontrolled cardiovascular disease or history of myocarditis
- Previous allogenic tissue or solid organ transplant
- Elevated Troponin T or I over twice the institutional upper limit
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection requiring systemic treatment
- Active Hepatitis B or C infection
- Known HIV infection
- Pregnant or breastfeeding
- Medical or social conditions preventing attendance to scheduled assessments or procedures
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
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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