Recruiting

Nivolumab and Relatlimab for Resectable Merkel Cell Carcinoma

Study Aim

This study aims to evaluate the effectiveness and safety of Nivolumab and Relatlimab in patients with resectable Merkel Cell Carcinoma by measuring the rate of complete response in tumor cells after treatment.

What is being tested

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

Drug

Who is being recruted

Adenocarcinoma+13

+ Carcinoma

+ DNA Virus Infections

Over 18 Years

+26 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: March 2024

See protocol details

Summary

Principal SponsorMelanoma Institute Australia

Study ContactMonica Osorio

Last updated: February 3, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 11, 2024

Actual date on which the first participant was enrolled.

This study focuses on testing a new treatment approach for Merkel cell carcinoma, a type of skin cancer that can be aggressive. The trial aims to see if using two immune system-boosting drugs, nivolumab and relatlimab, before surgery can improve outcomes for patients with stages I to III of this cancer. Patients in this trial have tumors that can be surgically removed and have not received any previous treatment for their cancer. The goal is to see if this combined treatment can lead to better cancer reduction and prevent the cancer from coming back compared to using nivolumab alone. In this study, participants receive the two drugs, nivolumab and relatlimab, as a neoadjuvant therapy, meaning they are given before the surgery to remove the cancer. The medications are administered to block certain pathways that may allow cancer cells to escape the immune system's attack. The effectiveness of this treatment is measured by examining how much the cancer shrinks and how long the patient remains free from cancer after the treatment. This study does not highlight potential risks or benefits beyond this aim, focusing on the potential improvement of pathological response and recurrence-free survival.

Official TitleA Phase 2, Open Label, Single Arm Clinical Trial of Neoadjuvant Nivolumab and Relatlimab in Stage I To III Resectable Merkel Cell Carcinoma

NCT06151236

Principal SponsorMelanoma Institute Australia

Study ContactMonica Osorio

Last updated: February 3, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaDNA Virus InfectionsInfectionsNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueTumor Virus InfectionsVirus DiseasesCarcinoma, Merkel CellNeuroectodermal TumorsCarcinoma, NeuroendocrineNeuroendocrine TumorsPolyomavirus Infections

Criteria

11 inclusion criteria required to participate

Aged ≥ 18 years

Written consent

Histologically confirmed, resectable Merkel cell carcinoma with AJCC (8th ed) clinical stage I (≥ 10 mm), IIA, or IIB or III disease

In-transit metastases are permitted if they are completely resectable

Show More Criteria

15 exclusion criteria prevent from participating

A diagnosis of immunodeficiency or chronic steroid therapy >10 mg OD prednisone or equivalent

Has had an allogenic tissue/solid organ transplant

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

Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis or current interstitial lung disease

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Nivolumab and relatlimab will be administered in a fixed dose combination (FDC). The FDC product contains nivolumab and relatlimab in a protein-mass ratio of 3:1 (nivolumab 240 mg and relatlimab 80 mg): in a 20 mL concentrate solution per single vial. The dose and dosing regimen for this study is nivolumab 480 mg and relatlimab 160 mg - 2 vials per infusion. This was primarily based on the observed benefit/risk profile observed in metastatic melanoma patients from Study CA224-020 pharmacokinetics (PK), pharmacodynamics, and extensive nivolumab monotherapy clinical experience. In addition, the Phase 2/3 Study CA224-047 established this dose as active in unresectable and metastatic melanoma. This study is open label and single arm, with all patients scheduled to receive two doses of nivolumab and relatlimab FDC prior to surgery on days 1 and 29.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Melanoma Institute Australia

Wollstonecraft, AustraliaOpen Melanoma Institute Australia in Google Maps

Recruiting

One Study Center