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Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06151236•Melanoma Institute Australia

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged ≥ 18 years
•2. Written consent
•3. Histologically confirmed, resectable Merkel cell carcinoma with AJCC (8th ed) clinical or pathological stage I (≥ 10 mm), IIA, or IIB or III disease
•4. In-transit metastases are permitted if they are completely resectable
•5. Measurable disease according to RECIST 1.1 criteria
•6. Previous radiotherapy permitted if there is RECIST-measurable progression of disease since the completion of radiotherapy
•7. At least one of either, archival tissue from a primary or nodal MCC lesion (if applicable) for the current diagnosis and/or a newly obtained core biopsy of a lesion which has not been previously irradiated.
•8. ECOG 0-1
•9. Adequate organ function on blood pathology
•10. Life expectancy \>12 months
+1 more criteria

Exclusion Criteria

•1. Clinical, radiographic or pathological evidence of distant metastases
•2. Contraindication to nivolumab and / or relatlimab
•3. Prior anti-PD-1, CTLA-4, PDL-1 or LAG 3 antibody exposure, or an agent directed to another stimulatory or co-inhibitory T-cell receptor for any disease or any chemotherapy or experimental local or systemic drug treatment
•4. Active autoimmune disease or requirement for chronic steroid therapy other than hormone replacement therapy
•5. A diagnosis of immunodeficiency or chronic steroid therapy \>10 mg OD prednisone or equivalent
•6. Additional malignancy active within past 3 years; patients with chronic lymphocytic leukaemia can be included in this study.
•7. Uncontrolled cardiovascular disease or history of myocarditis
•8. Has had an allogenic tissue/solid organ transplant
•9. Troponin T (TnT) or I (TnI) \>2 × institutional ULN
•10. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis or current interstitial lung disease
+5 more criteria

Locations (1)

Melanoma Institute Australia

Wollstonecraft, New South Wales, Australia

Key Dates

Start Date

March 11, 2024

Primary Completion Date

December 1, 2026

Completion Date

April 1, 2034

Last Updated

February 17, 2026

Enrollment

ESTIMATED participants

Conditions

Merkel Cell Carcinoma

Interventions

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

DRUG

Contacts

Monica Osorio

CONTACT

+ 61 2 9911 7296 monica.osorio@melanoma.org.au

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma

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